NeoplasmsPhase 1ICGNCT02621268
Minimally Invasive Imagery With Indocyanine Green
A Phase 1 study testing Indocyanine Green in people with Neoplasms, run by University of Pennsylvania at 1 site in United States.
Trial summary
Determine if ICG administered pre-operatively, then imaged intraoperatively using our cameras, will aid in the identification of a suspected thoracic nodules, margins, lymph nodes and satellite nodules during minimally invasive procedures. The investigators intend on enrolling 48 Subjects in this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Indocyanine Green
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Nov 2016
- Phase
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients over 18 years of age
- Patients presenting with a thoracic nodule presumed to be resectable cancer on pre-operative assessment
- Good minimally invasive operative candidates as determined by a thoracic oncology multidisciplinary team
- Subject capable of giving informed consent and participating in the process of consent.
Who cannot join
- Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hCG) within 72 hours of surgery
- Subjects with a history of iodide allergies
- At-risk patient populations
- Homeless patients
- Patients with drug or alcohol dependence
- Children and neonates
- Patients unable to participate in the consent process
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Pilot & Feasibility Study of the Imaging Potential of Indocyanine Green in Subjects Undergoing Minimally Invasive Thoracic Surgery Presenting With Thoracic Nodules
Determine if ICG administered pre-operatively, then imaged intraoperatively using our cameras, will aid in the identification of a suspected thoracic nodules, margins, lymph nodes and satellite nodules during minimally invasive procedures. The investigators intend on enrolling 48 Subjects in this study. The study is focusing on patients presenting with suspected thoracic cancers who are considered to be good minimally invasive surgical candidates
Read the detailed description
According to the World Health Organization, lung cancer is the most common cause of cancer-related death in men and women, and is responsible for 1.3 million deaths worldwide annually as of 2004.
Surgery remains the best option for patients presenting with operable Stage I or II cancers, however the five year survival rate for these candidates remains at a dismal 53% for Stage I and 32% for Stage II (1). The high rates of recurrence suggest that surgeons are unable to completely detect and remove primary tumor nodules in a satisfactory manner as well as lingering metastases in sentinel lymph nodes. By ensuring a negative margin through near-infrared imagery it would be possible for us to improve the rates of recurrence free patients and thus overall survival.
The use of an ICG probe will allow for the operating field and lung tissue to be observed in real-time.
ICG has been used in the clinical settings since 1957. There is a wealth of data available attesting to the safety of this drug injected at its current clinically indicated dosing level. ICG has been shown to preferentially uptake in esophageal tumors as opposed to surrounding epithelial lumen after one minute of IV exposure (2). Additionally, the same group reported being able to better characterize the vascularization of the tumor to further clarify the invasiveness of the cancer. ICG usage has been shown to be safe in a similar clinical setting by the Gotoh group, who used ICG to detect and characterize bullous and emphysematous lesion of the lung in video assisted thoracoscopic surgeries (VATS) with Infrared Thoracoscopy that were not previously detectable by white light (3).
The currently proposed trial is a single center, open-label pilot/observational cohort study. Patients with a diagnosis of resectable thoracic nodule/mass who are presumed to be resectable via minimally invasive surgery as determined by pre-operative assessment at the Hospital of the University of Pennsylvania will be included.
- Conditions
- Neoplasms
- Being tested
- Indocyanine Green
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine GreenDrug
Also called ICG
Infusion of ICG 24 hours prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| Indocyanine Green | Experimental | Dosage calculated by weight of individual, 5mg/kg. Receives: Drug: Indocyanine Green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of imaging system to detect expression of ICG in nodule/mass (i.e. tumor) and discern uptake of dye by tumor
Detected with imaging probe during minimally invasive procedure
Measured: 36 months
Secondary outcomes (1)
Incidence rates of all adverse events, treatment-emergent adverse events, and adverse device events from time of ICG administration through participants' first, post-operative appointment with surgeon
Measured: 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startNov 2014
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sunil Singhall, University of Pennsylvania
- Investigators
- Sunil Singhal, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621268
- Sponsor's protocol ID
- 820766
- Acronym
- ICG
- Status last verified
- Mar 2018
- First submitted
- 1 Dec 2015
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mountain CF, Dresler CM. Regional lymph node classification for lung cancer staging. Chest. 1997 Jun;111(6):1718-23. doi: 10.1378/chest.111.6.1718.
PubMed 9187199Kimura T, Muguruma N, Ito S, Okamura S, Imoto Y, Miyamoto H, Kaji M, Kudo E. Infrared fluorescence endoscopy for the diagnosis of superficial gastric tumors. Gastrointest Endosc. 2007 Jul;66(1):37-43. doi: 10.1016/j.gie.2007.01.009.
PubMed 17591472Gotoh M, Yamamoto Y, Igai H, Chang S, Huang C, Yokomise H. Clinical application of infrared thoracoscopy to detect bullous or emphysematous lesions of the lung. J Thorac Cardiovasc Surg. 2007 Dec;134(6):1498-501. doi: 10.1016/j.jtcvs.2007.07.051.
PubMed 18023672
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot & Feasibility Study of the Imaging Potential of Indocyanine Green in Subjects Undergoing Minimally Invasive Thoracic Surgery Presenting With Thoracic Nodules
- ClinicalTrials.gov ID
- NCT02621268
- Acronym / sponsor ID
- ICG / 820766
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 3 Dec 2015 (estimated)
- 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.
Determine if ICG administered pre-operatively, then imaged intraoperatively using our cameras, will aid in the identification of a suspected thoracic nodules, margins, lymph nodes and satellite nodules during minimally invasive procedures. The investigators intend on enrolling 48 Subjects in this study. The study is focusing on patients presenting with suspected thoracic cancers who are considered to be good minimally invasive surgical candidates
Detailed description
According to the World Health Organization, lung cancer is the most common cause of cancer-related death in men and women, and is responsible for 1.3 million deaths worldwide annually as of 2004.
Surgery remains the best option for patients presenting with operable Stage I or II cancers, however the five year survival rate for these candidates remains at a dismal 53% for Stage I and 32% for Stage II (1). The high rates of recurrence suggest that surgeons are unable to completely detect and remove primary tumor nodules in a satisfactory manner as well as lingering metastases in sentinel lymph nodes. By ensuring a negative margin through near-infrared imagery it would be possible for us to improve the rates of recurrence free patients and thus overall survival.
The use of an ICG probe will allow for the operating field and lung tissue to be observed in real-time.
ICG has been used in the clinical settings since 1957. There is a wealth of data available attesting to the safety of this drug injected at its current clinically indicated dosing level. ICG has been shown to preferentially uptake in esophageal tumors as opposed to surrounding epithelial lumen after one minute of IV exposure (2). Additionally, the same group reported being able to better characterize the vascularization of the tumor to further clarify the invasiveness of the cancer. ICG usage has been shown to be safe in a similar clinical setting by the Gotoh group, who used ICG to detect and characterize bullous and emphysematous lesion of the lung in video assisted thoracoscopic surgeries (VATS) with Infrared Thoracoscopy that were not previously detectable by white light (3).
The currently proposed trial is a single center, open-label pilot/observational cohort study. Patients with a diagnosis of resectable thoracic nodule/mass who are presumed to be resectable via minimally invasive surgery as determined by pre-operative assessment at the Hospital of the University of Pennsylvania will be included.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Indocyanine Green | Experimental | Drug: Indocyanine GreenDosage calculated by weight of individual, 5mg/kg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients over 18 years of age
- Patients presenting with a thoracic nodule presumed to be resectable cancer on pre-operative assessment
- Good minimally invasive operative candidates as determined by a thoracic oncology multidisciplinary team
- Subject capable of giving informed consent and participating in the process of consent.
Key exclusion criteria (7 listed)
- Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hCG) within 72 hours of surgery
- Subjects with a history of iodide allergies
- At-risk patient populations
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 |
|---|---|---|
| Indocyanine GreenAlso: ICGInfusion of ICG 24 hours prior to surgery | Drug | Indocyanine Green |
Primary outcome
Ability of imaging system to detect expression of ICG in nodule/mass (i.e. tumor) and discern uptake of dye by tumor
Time frame: 36 months
Detected with imaging probe during minimally invasive procedure
1 secondary outcome
Incidence rates of all adverse events, treatment-emergent adverse events, and adverse device events from time of ICG administration through participants' first, post-operative appointment with surgeon
Time frame: 36 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
- Background: PubMed 9187199Mountain CF, Dresler CM. Regional lymph node classification for lung cancer staging. Chest. 1997 Jun;111(6):1718-23. doi: 10.1378/chest.111.6.1718.
- Background: PubMed 17591472Kimura T, Muguruma N, Ito S, Okamura S, Imoto Y, Miyamoto H, Kaji M, Kudo E. Infrared fluorescence endoscopy for the diagnosis of superficial gastric tumors. Gastrointest Endosc. 2007 Jul;66(1):37-43. doi: 10.1016/j.gie.2007.01.009.
- Background: PubMed 18023672Gotoh M, Yamamoto Y, Igai H, Chang S, Huang C, Yokomise H. Clinical application of infrared thoracoscopy to detect bullous or emphysematous lesions of the lung. J Thorac Cardiovasc Surg. 2007 Dec;134(6):1498-501. doi: 10.1016/j.jtcvs.2007.07.051.
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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.
Sunil Singhal, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Indocyanine Green in people with Neoplasms, run by University of Pennsylvania at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 20 Mar 2018. 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 United States. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability of imaging system to detect expression of ICG in nodule/mass (i.e. tumor) and discern uptake of dye by tumor (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02621268, which also lists 3 linked publications.
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 20 Mar 2018.