Stomach NeoplasmNCT06435741
Molecular Imaging of Gastric Cancer Metastatic Lymph Nodes with 99mTc-3PRGD2 Probe.
A study testing 99mTc-3PRGD2 Spect-CT scan in people with Stomach Neoplasm and Lymph Node Metastasis, run by Peking University Cancer Hospital & Institute.
Trial summary
Surgical lymph node dissection is the key to advanced gastric cancer. In recent years, after the overall implementation of standard D2 dissection, lymph node dissection for gastric cancer began to explore the direction of D1+ again. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stomach Neoplasm, Lymph Node Metastasis, RADIONUCLIDE IMAGING
- What is being tested?
- 99mTc-3PRGD2 Spect-CT scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 6 Jun 2024to 31 Dec 2025
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gastric adenocarcinoma was confirmed by histological examination, and the clinical stage was cT2-4N+M0 locally advanced stage;
- Age 18-75 years old;
- No previous drug treatment, radiotherapy and other treatments;
- ECOG 0~1 points, KPS>70 points;
- The baseline blood routine and biochemical indexes of the subjects meet the following criteria: hemoglobin ≥90g/L; Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet ≥100×109/L; ALT, AST≤2.5 times the normal upper limit; ALP≤2.5 times the normal upper limit; Serum total bilirubin <1.5 times the normal upper limit; Serum creatinine <1 times the normal upper limit; Serum albumin ≥30g/L;
- Radical surgical resection (D2 lymph dissection) was performed in all patients.
- Willing and able to comply with the plan during the study;
- Provide written informed consent before entering the study screening, and the patient has understood that he or she can withdraw from the study at any time of the study with no loss.
Who cannot join
- Pregnant or nursing women;
- Clinically serious (i.e., active) heart disease, such as symptomatic coronary heart disease, NYHA Class II or worse congestive heart failure, or severe arrhythmia requiring medical intervention (see Appendix 12), or a history of myocardial infarction within the last 12 months;
- Moderate or severe renal impairment [creatinine clearance equal to or less than 50 ml/min (calculated from Cockroft and Gault equations)], or serum creatinine > the upper limit of normal (ULN);
- Patients with impaired liver function, ALT or AST less than or equal to 3×ULN, total bilirubin less than or equal to 1.5 ×ULN, or with proven Gilbert syndrome at baseline (unbound hyperbilirubinemia), serum albumin greater than or equal to 3.0 g/dL;
- History of iodine allergy (ICG contains iodine) or allergy to ICG;
- History of hyperthyroidism;
- Under the physiological function state of the general elderly, the drug should be administered with caution.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Lymph Node Dissection of Gastric Cancer Based on Molecular Imaging of Metastatic Lymph Nodes of Gastric Cancer with 99mTc-3PRGD2 Probes
Surgical lymph node dissection is the key to advanced gastric cancer. In recent years, after the overall implementation of standard D2 dissection, lymph node dissection for gastric cancer began to explore the direction of D1+ again. Current clinical studies of gastric cancer lymph node dissection based on intraoperative fluorescence navigation show that non-tumor specific lymph node fluorescence navigation surgery can only increase the total number of lymph nodes detected and ensure the completion of the dissection but not the accuracy. The sensitivity and specificity of the tracer metastatic lymph nodes are 56.3% (410/728), respectively. Specificity 46.1% (2669/5785). Tumor specific tracing of positive lymph nodes is the key to achieve accurate lymph node dissection for gastric cancer. Although tumor specific tracers are developing rapidly and related clinical studies are gradually being carried out, there are few reports on specific clinical studies on lymph node metastasis, suggesting that lymph node tracing is still a difficult problem. Previous basic studies have suggested that integrins play an important molecular biological role in the process of tumor lymph node metastasis. In the early stage, 99mTc3PRGD2 SPECT-CT showed good lymph node imaging effect in lung cancer and breast cancer, and 99mTc-oncoFAPI PET-CT also showed good lymph node imaging effect in gastric cancer. Therefore, this study aims to explore the application prospect of 99mTc3PRGD2 and other probes in molecular imaging of gastric cancer metastatic lymph nodes and guidance of lymph node dissection and tracer, so as to accumulate preliminary clinical data for exploring corresponding fluorescent probes for intraoperative tracer of gastric cancer lymph nodes.
- Being tested
- 99mTc-3PRGD2 Spect-CT scan
- Keywords
- Gastric cancer, Lymph node metastasis, Tumor molecular imaging, Integrin, Fibroblast activating protein
- Medical subject headings
- Stomach Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
99mTc-3PRGD2 Spect-CT scanDiagnostic test
Before the operation，SPECT-CT imaging of lymph nodes was performed by integrin αvβ3-specific 99mTc-3PRGD2 probe. The locations of 99mTc-3PRGD2 SPECT-CT were determined by preoperative CT scan. During the operation, D2 lymph node dissection of gastric cancer was performed under the guidance of fluorescent laparoscopy。
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | there is only one arm the included patients in which receive 99mTc-3PRGD2 Spect-CT scan. Receives: Diagnostic Test: 99mTc-3PRGD2 Spect-CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of 99mTc-3PRGD2 SPECT-CT imaging of metastatic lymph nodes in gastric cancer.
Measured: the sensitivity and specificity were determined according to pathological finding after operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start6 Jun 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, jiayongning, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435741
- Sponsor's protocol ID
- QNJJ2022017
- Status last verified
- Sep 2023
- First submitted
- 26 May 2024
- Last updated
- 30 May 2024
- 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 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymph Node Dissection of Gastric Cancer Based on Molecular Imaging of Metastatic Lymph Nodes of Gastric Cancer with 99mTc-3PRGD2 Probes
- ClinicalTrials.gov ID
- NCT06435741
- Acronym / sponsor ID
- QNJJ2022017
- Keywords
- Gastric cancer, Lymph node metastasis, Tumor molecular imaging, Integrin, Fibroblast activating protein
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 6 Jun 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 May 2024 (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.
Surgical lymph node dissection is the key to advanced gastric cancer. In recent years, after the overall implementation of standard D2 dissection, lymph node dissection for gastric cancer began to explore the direction of D1+ again. Current clinical studies of gastric cancer lymph node dissection based on intraoperative fluorescence navigation show that non-tumor specific lymph node fluorescence navigation surgery can only increase the total number of lymph nodes detected and ensure the completion of the dissection but not the accuracy. The sensitivity and specificity of the tracer metastatic lymph nodes are 56.3% (410/728), respectively. Specificity 46.1% (2669/5785). Tumor specific tracing of positive lymph nodes is the key to achieve accurate lymph node dissection for gastric cancer. Although tumor specific tracers are developing rapidly and related clinical studies are gradually being carried out, there are few reports on specific clinical studies on lymph node metastasis, suggesting that lymph node tracing is still a difficult problem. Previous basic studies have suggested that integrins play an important molecular biological role in the process of tumor lymph node metastasis. In the early stage, 99mTc3PRGD2 SPECT-CT showed good lymph node imaging effect in lung cancer and breast cancer, and 99mTc-oncoFAPI PET-CT also showed good lymph node imaging effect in gastric cancer. Therefore, this study aims to explore the application prospect of 99mTc3PRGD2 and other probes in molecular imaging of gastric cancer metastatic lymph nodes and guidance of lymph node dissection and tracer, so as to accumulate preliminary clinical data for exploring corresponding fluorescent probes for intraoperative tracer of gastric cancer lymph nodes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Diagnostic Test: 99mTc-3PRGD2 Spect-CT scanthere is only one arm the included patients in which receive 99mTc-3PRGD2 Spect-CT scan. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Gastric adenocarcinoma was confirmed by histological examination, and the clinical stage was cT2-4N+M0 locally advanced stage;
- Age 18-75 years old;
- No previous drug treatment, radiotherapy and other treatments;
- ECOG 0~1 points, KPS>70 points;
- The baseline blood routine and biochemical indexes of the subjects meet the following criteria: hemoglobin ≥90g/L; Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet ≥100×109/L; ALT, AST≤2.5 times the normal upper limit; ALP≤2.5 times the normal upper limit; Serum total bilirubin <1.5 times the normal upper limit; Serum creatinine <1 times the normal upper limit; Serum albumin ≥30g/L;
Key exclusion criteria (7 listed)
- Pregnant or nursing women;
- Clinically serious (i.e., active) heart disease, such as symptomatic coronary heart disease, NYHA Class II or worse congestive heart failure, or severe arrhythmia requiring medical intervention (see Appendix 12), or a history of myocardial infarction within the last 12 months;
- Moderate or severe renal impairment [creatinine clearance equal to or less than 50 ml/min (calculated from Cockroft and Gault equations)], or serum creatinine > the upper limit of normal (ULN);
- Patients with impaired liver function, ALT or AST less than or equal to 3×ULN, total bilirubin less than or equal to 1.5 ×ULN, or with proven Gilbert syndrome at baseline (unbound hyperbilirubinemia), serum albumin greater than or equal to 3.0 g/dL;
- History of iodine allergy (ICG contains iodine) or allergy to ICG;
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-3PRGD2 Spect-CT scanBefore the operation，SPECT-CT imaging of lymph nodes was performed by integrin αvβ3-specific 99mTc-3PRGD2 probe. The locations of 99mTc-3PRGD2 SPECT-CT were determined by preoperative CT scan. During the operation, D2 lymph node dissection of gastric cancer was performed under the guidance of fluorescent laparoscopy。 | Diagnostic test | Experimental arm |
Primary outcome
Sensitivity and specificity of 99mTc-3PRGD2 SPECT-CT imaging of metastatic lymph nodes in gastric cancer.
Time frame: the sensitivity and specificity were determined according to pathological finding after operation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Individual participant dataSharing planned: No
Related trials for Stomach Neoplasm
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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.
Questions about this trial
What is this clinical trial studying?
A study testing 99mTc-3PRGD2 Spect-CT scan in people with Stomach Neoplasm and Lymph Node Metastasis, run by Peking University Cancer Hospital & Institute.
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 7 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 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
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 yongning Jia (0086-10-88196606, yongningjia@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of 99mTc-3PRGD2 SPECT-CT imaging of metastatic lymph nodes in gastric cancer. (time frame: the sensitivity and specificity were determined according to pathological finding after operation.). 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 30 May 2024.