Lung CancerEarly Phase 1NCT05039905
SLN Detection With Tc-MSA-ICG in Lung Cancer Patients
A Early Phase 1 study testing 99mTc-MSA-ICG in people with Lung Cancer, run by Korea University Guro Hospital at 1 site in South Korea.
Trial summary
It is necessary to develop a technique of sentinel lymph node detection using radioactive fluorescent dual contrast agent consisting targetable albumin for specific marker to accurately determine whether or not the sentinel lymph nodes have metastasized or non-metastasized. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- 99mTc-MSA-ICG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Feb 2021to 31 Dec 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Preoperative examinations (chest CT, PET/CT, bone scan, brain MRI) diagnosed the clinical stage as T1a or T1b with the size the cancer less than 2 cm and adenocarcinoma or square cell carcinoma through preoperative biopsy, with no lymph node or other diseases and lung disease. A person who meets the conditions described below and does not fall under the exclusion criteria is selected as an adult.
- Eastern cooperative oncology group (ECOG) performance scale: 0~2
- White blood cell count ≥ 3,000/㎣ and ≤ 12,000/㎣
- Neutrophil count ≥ 1,500/㎣
- Platelet count ≥ 100,000/㎣
- AST, ALT ≤ 2.5 times the upper limit
- Total bilirubin ≤ 2.5 times the upper limit
- Serum creatinine ≤ 1.5 time the upper limit
Who cannot join
- Those who do not agree or refuse to participate in the research
- A person who is not suitable for general anesthesia
- A person with a clinically significant acute or unstable condition
- A person with the following serious heart disease
- congestive heart failure with symptoms
- New York Heart Association III/IV Class Heart Disease
Show all 20Show fewer
- Unstable angina
- Symptom or unregulated heart arrhythmia
- Myocardial infarction within the past three months
- QT interval (QTcF) using Fridricia calibration
- Family history of long QT syndrome
- Those who cannot be scanned (e.g., patients with claustrophobia, ect.)
- A person who received a therapeutic radiation dose within four weeks prior to participation in the study ([18F]FDG has a half-life of 109 minutes, so after 18.2 hours, 99mTc-MDP has a half-life of 6 hours, that is after 2.5 days)
- A person who is being administered drugs such as a drug metabolic enzyme inducer or inhibitor within four weeks before participating in the study
- A person who has overreacted or had side effects on clinical research medications (ICG or 99mTc).
- Patients with closed diseases
- Patients with iodine intolerance
- In the case of pregnant women/feeding mothers or pregnant women, those who do not agree to the use of appropriate contraception methods during the research period;
- A person who participated in another clinical study within 12 weeks before participating in the study and administered clinical research medications or received medical device procedures for clinical research.
- Those who are unfit to participate in this clinical study in the judgment of the research manager
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Guro Hospital
Seoul, 08308
Jiyun Rho, BA, 82-2-2626-1978, jiyun.r1219@gmail.com
Seunghoe Song, MBE, 82-2-2626-1635, ssessong@korea.ac.kr
About this study
Official title: Development of the Surgical Technique Using Radioactive Fluorescent Dual Contrast Agent for Intraoperative Sentinel Lymph Node Detection in Lung Cancer Patients
It is necessary to develop a technique of sentinel lymph node detection using radioactive fluorescent dual contrast agent consisting targetable albumin for specific marker to accurately determine whether or not the sentinel lymph nodes have metastasized or non-metastasized. Therefore, investigators would like to conduct a clinical trial to evaluate the effectiveness of radioactive fluorescent dual contrast agent to detect sentinel lymph nodes for patient-specific minimally invasive surgery.
Read the detailed description
It is necessary to develop a technique of sentinel lymph node detection using radioactive fluorescent dual contrast agent consisting targetable albumin for specific marker to accurately determine whether or not the sentinel lymph nodes have metastasized or non-metastasized. Therefore, investigators would like to conduct a clinical trial to evaluate the effectiveness of radioactive fluorescent dual contrast agent (99mTc-MSA-ICG) to detect sentinel lymph nodes for patient-specific minimally invasive surgery.
To analyze the effectiveness of radioactive fluorescent dual contrast agent (99mTc-MSA-ICG) for detecting sentinel lymph node, total 10 lung cancer patients will participate in this study.
- Conditions
- Lung Cancer
- Being tested
- 99mTc-MSA-ICG
- Keywords
- Lung Cancer, Sentinel lymph node, Radioactive fluorescent dual contrast agent
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
99mTc-MSA-ICGDrug
Intratumoral injection of 99mTechnetium-manosylated albumin-indocyanine green to lung cancer patients
| Study group | Role | What they receive |
|---|---|---|
| 99mTc-MSA-ICG injection | Experimental | 99mTc-MSA-ICG injection
1mCi of 99mTc
1mg of MSA 0.1mg of ICG Total 1cc injection volume at 2 hours before the surgery Receives: Drug: 99mTc-MSA-ICG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical chemistry examination-1 (CRP,Cholesterol,Ca,total,TotalBilirubin,directBilirubin,BUN,Creatinine,Phosphorus, inorganic)
Carrying out the clinical chemistry examination(CRP,Cholesterol,Ca,total,TotalBilirubin,directBilirubin,BUN,Creatinine,Phosphorus, inorganic) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery. (mg/dL)
Measured: Within two weeks before surgery
Clinical chemistry examination-2
Carrying out the clinical chemistry examination(CRP,Cholesterol,Ca,total,TotalBilirubin,directBilirubin,BUN,Creatinine,Phosphorus, inorganic) to check the drug-related safety in 10 lung cancer patients on postoperativeday(POD) 0 (mg/dL)
Measured: postoperative day 0
Clinical chemistry examination-3
Carrying out the clinical chemistry examination(CRP,Cholesterol,Ca,total,TotalBilirubin,directBilirubin,BUN,Creatinine,Phosphorus, inorganic) to check the drug-related safety in 10 lung cancer patients on POD 1 (mg/dL)
Measured: postoperative day 1
Clinical chemistry examination-4
Carrying out the clinical chemistry examination(CRP,Cholesterol,Ca,total,TotalBilirubin,directBilirubin,BUN,Creatinine,Phosphorus, inorganic) to check the drug-related safety in 10 lung cancer patients on POD 5 (mg/dL)
Measured: postoperative day 5
Clinical chemistry examination-5
Carrying out the clinical chemistry examination (Procalcitonin) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery. (ng/mL)
Measured: within two weeks before surgery
Clinical chemistry examination-6
Carrying out the clinical chemistry examination (Procalcitonin) to check the drug-related safety in 10 lung cancer patients on POD 0 (ng/mL)
Measured: postoperative day 0
Clinical chemistry examination-7
Carrying out the clinical chemistry examination (Procalcitonin) to check the drug-related safety in 10 lung cancer patients on POD 1 (ng/mL)
Measured: postoperative day 1
Clinical chemistry examination-8
Carrying out the clinical chemistry examination (Procalcitonin) to check the drug-related safety in 10 lung cancer patients on POD 5 (ng/mL)
Measured: postoperative day 5
Clinical chemistry examination-9
Carrying out the clinical chemistry examination (AST,ALT,LDH,ALP,GGT) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (IU/L)
Measured: within two weeks before surgery
Clinical chemistry examination-10
Carrying out the clinical chemistry examination (AST,ALT,LDH,ALP,GGT) to check the drug-related safety in 10 lung cancer patients on POD 0 (IU/L)
Measured: postoperative day 0
Clinical chemistry examination-11
Carrying out the clinical chemistry examination (AST,ALT,LDH,ALP,GGT) to check the drug-related safety in 10 lung cancer patients on POD 1 (IU/L)
Measured: postoperative day 1
Clinical chemistry examination-12
Carrying out the clinical chemistry examination (AST,ALT,LDH,ALP,GGT) to check the drug-related safety in 10 lung cancer patients on POD 5 (IU/L)
Measured: postoperative day 5
Clinical chemistry examination-13
Carrying out the clinical chemistry examination (Na, K, Cl) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (mmol/L)
Measured: within two weeks before surgery
Clinical chemistry examination-14
Carrying out the clinical chemistry examination (Na, K, Cl) to check the drug-related safety in 10 lung cancer patients on POD 0 (mmol/L)
Measured: postoperative day 0
Clinical chemistry examination-15
Carrying out the clinical chemistry examination (Na, K, Cl) to check the drug-related safety in 10 lung cancer patients on POD 1 (mmol/L)
Measured: postoperative day 1
Clinical chemistry examination-16
Carrying out the clinical chemistry examination (Na, K, Cl) to check the drug-related safety in 10 lung cancer patients on POD 5 (mmol/L)
Measured: postoperative day 5
Hematology examination-1
Carrying out the clinical chemistry examination (Mg) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery(mEq/L)
Measured: within two weeks before surgery
Hematology examination-2
Carrying out the clinical chemistry examination (Mg) to check the drug-related safety in 10 lung cancer patients on POD 0 (mEq/L)
Measured: postoperative day 0
Hematology examination-3
Carrying out the clinical chemistry examination (Mg) to check the drug-related safety in 10 lung cancer patients on POD 1 (mEq/L)
Measured: postoperative day 1
Hematology examination-4
Carrying out the clinical chemistry examination (Mg) to check the drug-related safety in 10 lung cancer patients on POD 5 (mEq/L)
Measured: postoperative day 5
Hematology examination-5
Carrying out the clinical hematology examination (hemoglobin, MCHC) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (g/dL)
Measured: within two weeks before surgery
Hematology examination-6
Carrying out the clinical hematology examination (hemoglobin, MCHC) to check the drug-related safety in 10 lung cancer patients on POD 0 (g/dL)
Measured: postoperative day 0
Hematology examination-7
Carrying out the clinical hematology examination (hemoglobin, MCHC) to check the drug-related safety in 10 lung cancer patients on POD 1 (g/dL)
Measured: postoperative day 1
Hematology examination-8
Carrying out the clinical hematology examination (hemoglobin, MCHC) to check the drug-related safety in 10 lung cancer patients on POD 5 (g/dL)
Measured: postoperative day 5
Hematology examination-9
Carrying out the clinical hematology examination (hematocrit, WBC differential) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (%)
Measured: within two weeks before surgery
Hematology examination-10
Carrying out the clinical hematology examination (hematocrit, WBC differential) to check the drug-related safety in 10 lung cancer patients on POD0 (%)
Measured: postoperative day 0
Hematology examination-11
Carrying out the clinical hematology examination (hematocrit, WBC differential) to check the drug-related safety in 10 lung cancer patients on POD1 (%)
Measured: postoperative day 1
Hematology examination-12
Carrying out the clinical hematology examination (hematocrit, WBC differential) to check the drug-related safety in 10 lung cancer patients on POD5 (%)
Measured: postoperative day 5
Hematology examination-13
Carrying out the clinical hematology examination (RBC count, WBC count, platelet count) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (10³/μl)
Measured: within two weeks before surgery
Hematology examination-14
Carrying out the clinical hematology examination (RBC count, WBC count, platelet count) to check the drug-related safety in 10 lung cancer patients on POD0 (10³/μl)
Measured: postoperative day 0
Hematology examination-15
Carrying out the clinical hematology examination (RBC count, WBC count, platelet count) to check the drug-related safety in 10 lung cancer patients on POD1 (10³/μl)
Measured: postoperative day 1
Hematology examination-16
Carrying out the clinical hematology examination (RBC count, WBC count, platelet count) to check the drug-related safety in 10 lung cancer patients on POD5 (10³/μl)
Measured: postoperative day 5
Hematology examination-17
Carrying out the clinical hematology examination (MCV) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery(fL)
Measured: within two weeks before surgery
Hematology examination-18
Carrying out the clinical hematology examination (MCV) to check the drug-related safety in 10 lung cancer patients on POD 0 (fL)
Measured: postoperative day 0
Hematology examination-19
Carrying out the clinical hematology examination (MCV) to check the drug-related safety in 10 lung cancer patients on POD 1(fL)
Measured: postoperative day 1
Hematology examination-20
Carrying out the clinical hematology examination (MCV) to check the drug-related safety in 10 lung cancer patients on POD 5 (fL)
Measured: postoperative day 5
Hematology examination- 21
Carrying out the clinical hematology examination (MCH) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (pg)
Measured: within two weeks before surgery
Hematology examination- 22
Carrying out the clinical hematology examination (MCH) to check the drug-related safety in 10 lung cancer patients and POD 0 (pg)
Measured: postoperative day 0
Hematology examination- 23
Carrying out the clinical hematology examination (MCH) to check the drug-related safety in 10 lung cancer patients on POD 1 (pg)
Measured: postoperative day 1
Hematology examination- 24
Carrying out the clinical hematology examination (MCH) to check the drug-related safety in 10 lung cancer patients on POD 5 (pg)
Measured: postoperative day 5
Hematology examination- 25
Carrying out the clinical hematology examination (PT, aPTT) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (sec)
Measured: within two weeks before surgery
Hematology examination- 26
Carrying out the clinical hematology examination (PT, aPTT) to check the drug-related safety in 10 lung cancer patients on POD 0 (sec)
Measured: postoperative day 0
Hematology examination- 27
Carrying out the clinical hematology examination (PT, aPTT) to check the drug-related safety in 10 lung cancer patients on POD 1 (sec)
Measured: postoperative day 1
Hematology examination- 28
Carrying out the clinical hematology examination (PT, aPTT) to check the drug-related safety in 10 lung cancer patients on POD 5 (sec)
Measured: postoperative day 5
Check for changes of urinalysis-1
Carrying out the urinalysis examination(specific gravity, pH, glucose, bilirubin in urine) within two weeks before surgery (number)
Measured: within two weeks before surgery
Check for changes of urinalysis-2
Carrying out the urinalysis examination(specific gravity, pH, glucose, bilirubin in urine) on POD 0 (number)
Measured: postoperative day 0
Check for changes of urinalysis-3
Carrying out the urinalysis examination(specific gravity, pH, glucose, bilirubin in urine) on POD 1(number)
Measured: postoperative day 1
Check for changes of urinalysis-4
Carrying out the urinalysis examination(specific gravity, pH, glucose, bilirubin in urine) on POD 5 (number)
Measured: postoperative day 5
Check for changes of urinalysis-5
Carrying out the urinalysis examination(ketone, blood, protein, urobilinogen, nitrate in urine) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (0 or +1)
Measured: within two weeks before surgery
Check for changes of urinalysis-6
Carrying out the urinalysis examination(ketone, blood, protein, urobilinogen, nitrate in urine) to check the drug-related safety in 10 lung cancer patients on POD 0 (0 or +1)
Measured: postoperative day 0
Check for changes of urinalysis-7
Carrying out the urinalysis examination(ketone, blood, protein, urobilinogen, nitrate in urine) to check the drug-related safety in 10 lung cancer patients on POD 1 (0 or +1)
Measured: postoperative day 1
Check for changes of urinalysis-8
Carrying out the urinalysis examination(ketone, blood, protein, urobilinogen, nitrate in urine) to check the drug-related safety in 10 lung cancer patients on POD 5 (0 or +1)
Measured: postoperative day 5
Check for changes of urinalysis-9
Carrying out the urinalysis examination(WBC in urine) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery(4 - 0 / HPF
Measured: within two weeks before surgery
Check for changes of urinalysis-10
Carrying out the urinalysis examination(WBC in urine) to check the drug-related safety in 10 lung cancer patients on POD 0 (4 - 0 / HPF)
Measured: postoperative day 0
Check for changes of urinalysis-11
Carrying out the urinalysis examination(WBC in urine) to check the drug-related safety in 10 lung cancer patients on POD 1 (4 - 0 / HPF)
Measured: postoperative day 1
Check for changes of urinalysis-12
Carrying out the urinalysis examination(WBC in urine) to check the drug-related safety in 10 lung cancer patients on POD 5 (4 - 0 / HPF)
Measured: postoperative day 5
Observation of the irritable adverse reaction
Observation of the irritable adverse reaction (Urticaria, angioedema, allergic rhinitis, anaphylaxis, exanthermatous eruption, fixed drug eruption, acneiform eruption, purpura eruption, urticarial eruption, bullous eruption, lichenoid eruption, Stevens-Johnson syndrom, acute generalized exanthematous pustulosis, toxic epidermal necrolysis) to check the drug-related safety in 10 lung cancer patients
Measured: Up to 2 hours after drug injection
Effective dose measurement
Measured: Up to five days after surgery
Secondary outcomes (2)
Confirm the sentinel lymph node identification rate
Calculation the percentage of cancer cells found in pathological test among sentinel lymph nodes where fluorescent or nuclear signal are detected.
Measured: Through study completion, an average of 1 year
Confirm the false negative rate
Calculation the proportion of cancer cells found in pathological tests among non-sentinel lymph nodes where no fluorescent or nuclear signals were detected.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start15 Feb 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Lung cancer patient
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun Koo Kim, Korea University Guro Hospital
- Investigators
- Hyun Koo Kim, MD, PhD, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039905
- Sponsor's protocol ID
- 2020GR0436
- Status last verified
- Sep 2021
- First submitted
- 15 Feb 2021
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of the Surgical Technique Using Radioactive Fluorescent Dual Contrast Agent for Intraoperative Sentinel Lymph Node Detection in Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT05039905
- Acronym / sponsor ID
- 2020GR0436
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer, Sentinel lymph node, Radioactive fluorescent dual contrast agent
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 10 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is necessary to develop a technique of sentinel lymph node detection using radioactive fluorescent dual contrast agent consisting targetable albumin for specific marker to accurately determine whether or not the sentinel lymph nodes have metastasized or non-metastasized. Therefore, investigators would like to conduct a clinical trial to evaluate the effectiveness of radioactive fluorescent dual contrast agent to detect sentinel lymph nodes for patient-specific minimally invasive surgery.
Detailed description
It is necessary to develop a technique of sentinel lymph node detection using radioactive fluorescent dual contrast agent consisting targetable albumin for specific marker to accurately determine whether or not the sentinel lymph nodes have metastasized or non-metastasized. Therefore, investigators would like to conduct a clinical trial to evaluate the effectiveness of radioactive fluorescent dual contrast agent (99mTc-MSA-ICG) to detect sentinel lymph nodes for patient-specific minimally invasive surgery.
To analyze the effectiveness of radioactive fluorescent dual contrast agent (99mTc-MSA-ICG) for detecting sentinel lymph node, total 10 lung cancer patients will participate in this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Lung cancer patient
| Arm | Type | Receives |
|---|---|---|
| 99mTc-MSA-ICG injection | Experimental | Drug: 99mTc-MSA-ICG99mTc-MSA-ICG injection 1mCi of 99mTc 1mg of MSA 0.1mg of ICG Total 1cc injection volume at 2 hours before the surgery |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Preoperative examinations (chest CT, PET/CT, bone scan, brain MRI) diagnosed the clinical stage as T1a or T1b with the size the cancer less than 2 cm and adenocarcinoma or square cell carcinoma through preoperative biopsy, with no lymph node or other diseases and lung disease. A person who meets the conditions described below and does not fall under the exclusion criteria is selected as an adult.
- Eastern cooperative oncology group (ECOG) performance scale: 0~2
- White blood cell count ≥ 3,000/㎣ and ≤ 12,000/㎣
- Neutrophil count ≥ 1,500/㎣
- Platelet count ≥ 100,000/㎣
Key exclusion criteria (20 listed)
- Those who do not agree or refuse to participate in the research
- A person who is not suitable for general anesthesia
- A person with a clinically significant acute or unstable condition
- A person with the following serious heart disease
- Those who cannot be scanned (e.g., patients with claustrophobia, ect.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 99mTc-MSA-ICGIntratumoral injection of 99mTechnetium-manosylated albumin-indocyanine green to lung cancer patients | Drug | 99mTc-MSA-ICG injection |
Primary outcome
Clinical chemistry examination-1 (CRP,Cholesterol,Ca,total,TotalBilirubin,directBilirubin,BUN,Creatinine,Phosphorus, inorganic)
Time frame: Within two weeks before surgery
Carrying out the clinical chemistry examination(CRP,Cholesterol,Ca,total,TotalBilirubin,directBilirubin,BUN,Creatinine,Phosphorus, inorganic) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery. (mg/dL)
Clinical chemistry examination-2
Time frame: postoperative day 0
Carrying out the clinical chemistry examination(CRP,Cholesterol,Ca,total,TotalBilirubin,directBilirubin,BUN,Creatinine,Phosphorus, inorganic) to check the drug-related safety in 10 lung cancer patients on postoperativeday(POD) 0 (mg/dL)
Clinical chemistry examination-3
Time frame: postoperative day 1
Carrying out the clinical chemistry examination(CRP,Cholesterol,Ca,total,TotalBilirubin,directBilirubin,BUN,Creatinine,Phosphorus, inorganic) to check the drug-related safety in 10 lung cancer patients on POD 1 (mg/dL)
Clinical chemistry examination-4
Time frame: postoperative day 5
Carrying out the clinical chemistry examination(CRP,Cholesterol,Ca,total,TotalBilirubin,directBilirubin,BUN,Creatinine,Phosphorus, inorganic) to check the drug-related safety in 10 lung cancer patients on POD 5 (mg/dL)
Clinical chemistry examination-5
Time frame: within two weeks before surgery
Carrying out the clinical chemistry examination (Procalcitonin) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery. (ng/mL)
Clinical chemistry examination-6
Time frame: postoperative day 0
Carrying out the clinical chemistry examination (Procalcitonin) to check the drug-related safety in 10 lung cancer patients on POD 0 (ng/mL)
Clinical chemistry examination-7
Time frame: postoperative day 1
Carrying out the clinical chemistry examination (Procalcitonin) to check the drug-related safety in 10 lung cancer patients on POD 1 (ng/mL)
Clinical chemistry examination-8
Time frame: postoperative day 5
Carrying out the clinical chemistry examination (Procalcitonin) to check the drug-related safety in 10 lung cancer patients on POD 5 (ng/mL)
Clinical chemistry examination-9
Time frame: within two weeks before surgery
Carrying out the clinical chemistry examination (AST,ALT,LDH,ALP,GGT) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (IU/L)
Clinical chemistry examination-10
Time frame: postoperative day 0
Carrying out the clinical chemistry examination (AST,ALT,LDH,ALP,GGT) to check the drug-related safety in 10 lung cancer patients on POD 0 (IU/L)
Clinical chemistry examination-11
Time frame: postoperative day 1
Carrying out the clinical chemistry examination (AST,ALT,LDH,ALP,GGT) to check the drug-related safety in 10 lung cancer patients on POD 1 (IU/L)
Clinical chemistry examination-12
Time frame: postoperative day 5
Carrying out the clinical chemistry examination (AST,ALT,LDH,ALP,GGT) to check the drug-related safety in 10 lung cancer patients on POD 5 (IU/L)
Clinical chemistry examination-13
Time frame: within two weeks before surgery
Carrying out the clinical chemistry examination (Na, K, Cl) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (mmol/L)
Clinical chemistry examination-14
Time frame: postoperative day 0
Carrying out the clinical chemistry examination (Na, K, Cl) to check the drug-related safety in 10 lung cancer patients on POD 0 (mmol/L)
Clinical chemistry examination-15
Time frame: postoperative day 1
Carrying out the clinical chemistry examination (Na, K, Cl) to check the drug-related safety in 10 lung cancer patients on POD 1 (mmol/L)
Clinical chemistry examination-16
Time frame: postoperative day 5
Carrying out the clinical chemistry examination (Na, K, Cl) to check the drug-related safety in 10 lung cancer patients on POD 5 (mmol/L)
Hematology examination-1
Time frame: within two weeks before surgery
Carrying out the clinical chemistry examination (Mg) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery(mEq/L)
Hematology examination-2
Time frame: postoperative day 0
Carrying out the clinical chemistry examination (Mg) to check the drug-related safety in 10 lung cancer patients on POD 0 (mEq/L)
Hematology examination-3
Time frame: postoperative day 1
Carrying out the clinical chemistry examination (Mg) to check the drug-related safety in 10 lung cancer patients on POD 1 (mEq/L)
Hematology examination-4
Time frame: postoperative day 5
Carrying out the clinical chemistry examination (Mg) to check the drug-related safety in 10 lung cancer patients on POD 5 (mEq/L)
Hematology examination-5
Time frame: within two weeks before surgery
Carrying out the clinical hematology examination (hemoglobin, MCHC) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (g/dL)
Hematology examination-6
Time frame: postoperative day 0
Carrying out the clinical hematology examination (hemoglobin, MCHC) to check the drug-related safety in 10 lung cancer patients on POD 0 (g/dL)
Hematology examination-7
Time frame: postoperative day 1
Carrying out the clinical hematology examination (hemoglobin, MCHC) to check the drug-related safety in 10 lung cancer patients on POD 1 (g/dL)
Hematology examination-8
Time frame: postoperative day 5
Carrying out the clinical hematology examination (hemoglobin, MCHC) to check the drug-related safety in 10 lung cancer patients on POD 5 (g/dL)
Hematology examination-9
Time frame: within two weeks before surgery
Carrying out the clinical hematology examination (hematocrit, WBC differential) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (%)
Hematology examination-10
Time frame: postoperative day 0
Carrying out the clinical hematology examination (hematocrit, WBC differential) to check the drug-related safety in 10 lung cancer patients on POD0 (%)
Hematology examination-11
Time frame: postoperative day 1
Carrying out the clinical hematology examination (hematocrit, WBC differential) to check the drug-related safety in 10 lung cancer patients on POD1 (%)
Hematology examination-12
Time frame: postoperative day 5
Carrying out the clinical hematology examination (hematocrit, WBC differential) to check the drug-related safety in 10 lung cancer patients on POD5 (%)
Hematology examination-13
Time frame: within two weeks before surgery
Carrying out the clinical hematology examination (RBC count, WBC count, platelet count) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (10³/μl)
Hematology examination-14
Time frame: postoperative day 0
Carrying out the clinical hematology examination (RBC count, WBC count, platelet count) to check the drug-related safety in 10 lung cancer patients on POD0 (10³/μl)
Hematology examination-15
Time frame: postoperative day 1
Carrying out the clinical hematology examination (RBC count, WBC count, platelet count) to check the drug-related safety in 10 lung cancer patients on POD1 (10³/μl)
Hematology examination-16
Time frame: postoperative day 5
Carrying out the clinical hematology examination (RBC count, WBC count, platelet count) to check the drug-related safety in 10 lung cancer patients on POD5 (10³/μl)
Hematology examination-17
Time frame: within two weeks before surgery
Carrying out the clinical hematology examination (MCV) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery(fL)
Hematology examination-18
Time frame: postoperative day 0
Carrying out the clinical hematology examination (MCV) to check the drug-related safety in 10 lung cancer patients on POD 0 (fL)
Hematology examination-19
Time frame: postoperative day 1
Carrying out the clinical hematology examination (MCV) to check the drug-related safety in 10 lung cancer patients on POD 1(fL)
Hematology examination-20
Time frame: postoperative day 5
Carrying out the clinical hematology examination (MCV) to check the drug-related safety in 10 lung cancer patients on POD 5 (fL)
Hematology examination- 21
Time frame: within two weeks before surgery
Carrying out the clinical hematology examination (MCH) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (pg)
Hematology examination- 22
Time frame: postoperative day 0
Carrying out the clinical hematology examination (MCH) to check the drug-related safety in 10 lung cancer patients and POD 0 (pg)
Hematology examination- 23
Time frame: postoperative day 1
Carrying out the clinical hematology examination (MCH) to check the drug-related safety in 10 lung cancer patients on POD 1 (pg)
Hematology examination- 24
Time frame: postoperative day 5
Carrying out the clinical hematology examination (MCH) to check the drug-related safety in 10 lung cancer patients on POD 5 (pg)
Hematology examination- 25
Time frame: within two weeks before surgery
Carrying out the clinical hematology examination (PT, aPTT) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (sec)
Hematology examination- 26
Time frame: postoperative day 0
Carrying out the clinical hematology examination (PT, aPTT) to check the drug-related safety in 10 lung cancer patients on POD 0 (sec)
Hematology examination- 27
Time frame: postoperative day 1
Carrying out the clinical hematology examination (PT, aPTT) to check the drug-related safety in 10 lung cancer patients on POD 1 (sec)
Hematology examination- 28
Time frame: postoperative day 5
Carrying out the clinical hematology examination (PT, aPTT) to check the drug-related safety in 10 lung cancer patients on POD 5 (sec)
Check for changes of urinalysis-1
Time frame: within two weeks before surgery
Carrying out the urinalysis examination(specific gravity, pH, glucose, bilirubin in urine) within two weeks before surgery (number)
Check for changes of urinalysis-2
Time frame: postoperative day 0
Carrying out the urinalysis examination(specific gravity, pH, glucose, bilirubin in urine) on POD 0 (number)
Check for changes of urinalysis-3
Time frame: postoperative day 1
Carrying out the urinalysis examination(specific gravity, pH, glucose, bilirubin in urine) on POD 1(number)
Check for changes of urinalysis-4
Time frame: postoperative day 5
Carrying out the urinalysis examination(specific gravity, pH, glucose, bilirubin in urine) on POD 5 (number)
Check for changes of urinalysis-5
Time frame: within two weeks before surgery
Carrying out the urinalysis examination(ketone, blood, protein, urobilinogen, nitrate in urine) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (0 or +1)
Check for changes of urinalysis-6
Time frame: postoperative day 0
Carrying out the urinalysis examination(ketone, blood, protein, urobilinogen, nitrate in urine) to check the drug-related safety in 10 lung cancer patients on POD 0 (0 or +1)
Check for changes of urinalysis-7
Time frame: postoperative day 1
Carrying out the urinalysis examination(ketone, blood, protein, urobilinogen, nitrate in urine) to check the drug-related safety in 10 lung cancer patients on POD 1 (0 or +1)
Check for changes of urinalysis-8
Time frame: postoperative day 5
Carrying out the urinalysis examination(ketone, blood, protein, urobilinogen, nitrate in urine) to check the drug-related safety in 10 lung cancer patients on POD 5 (0 or +1)
Check for changes of urinalysis-9
Time frame: within two weeks before surgery
Carrying out the urinalysis examination(WBC in urine) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery(4 - 0 / HPF
Check for changes of urinalysis-10
Time frame: postoperative day 0
Carrying out the urinalysis examination(WBC in urine) to check the drug-related safety in 10 lung cancer patients on POD 0 (4 - 0 / HPF)
Check for changes of urinalysis-11
Time frame: postoperative day 1
Carrying out the urinalysis examination(WBC in urine) to check the drug-related safety in 10 lung cancer patients on POD 1 (4 - 0 / HPF)
Check for changes of urinalysis-12
Time frame: postoperative day 5
Carrying out the urinalysis examination(WBC in urine) to check the drug-related safety in 10 lung cancer patients on POD 5 (4 - 0 / HPF)
Observation of the irritable adverse reaction
Time frame: Up to 2 hours after drug injection
Observation of the irritable adverse reaction (Urticaria, angioedema, allergic rhinitis, anaphylaxis, exanthermatous eruption, fixed drug eruption, acneiform eruption, purpura eruption, urticarial eruption, bullous eruption, lichenoid eruption, Stevens-Johnson syndrom, acute generalized exanthematous pustulosis, toxic epidermal necrolysis) to check the drug-related safety in 10 lung cancer patients
Effective dose measurement
Time frame: Up to five days after surgery
2 secondary outcomes
Confirm the sentinel lymph node identification rate
Time frame: Through study completion, an average of 1 year
Confirm the false negative rate
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyun Koo Kim, MD, PhD principal investigator
Korea University Guro Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 99mTc-MSA-ICG in people with Lung Cancer, run by Korea University Guro Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyun Koo Kim, MD, PhD (82-2-2626-3106, kimhyunkoo@korea.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical chemistry examination-1 (CRP,Cholesterol,Ca,total,TotalBilirubin,directBilirubin,BUN,Creatinine,Phosphorus, inorganic) (time frame: Within two weeks before surgery). The study lists 58 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2021.