Pulmonary Nodule, SolitaryPhase 1/2NCT03097627
Intravenous Indocyanine Green for Localization of Intra-thoracic Lesions
A Phase 1/2 study testing ICG Intervention and Near Infrared Camera in people with Pulmonary Nodule, Solitary and Pulmonary Nodule, Multiple, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This is a clinical trial to evaluate the intravenous administration of indocyanine green (ICG) as a method of intra-thoracic lesion localization. The primary purpose is to determine if intravenous ICG allows us to identify intra-thoracic lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Nodule, Solitary, Pulmonary Nodule, Multiple
- What is being tested?
- ICG Intervention and Near Infrared Camera
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2016to 28 Oct 2016
- Phase
- Phase 1/2
- 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
- Patients with intra-thoracic lesions that require resection for therapeutic or diagnostic purposes as recommended by their thoracic surgeon.
- 18 years of age or older
- Documented, signed, dated informed consent obtained prior to any study specific procedures being performed
Who cannot join
- Subjects who do not wish to have subsequent surgical resection
- A medical condition such as uncontrolled infection or cardiac disease that, in the opinion of the treating surgeon, makes resection unreasonably hazardous for the patient
- Pre-operative spirometry that suggests the patient is at high risk or cannot undergo resection of the primary tumor.
- Iodide or seafood allergy
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
This is a clinical trial to evaluate the intravenous administration of indocyanine green (ICG) as a method of intra-thoracic lesion localization. The primary purpose is to determine if intravenous ICG allows us to identify intra-thoracic lesions.
Read the detailed description
- This study is designed to determine the safety and feasibility of intra-operative localization of thoracic lesions following intravenous injection of indocyanine green (ICG), determine if intravenous ICG leads to the intra-operative detection of intra-thoracic lesions or metastatic lymph nodes not readily identifiable on conventional diagnostic imaging modalities, and determine if intravenous ICG improves surgical resection.
- At the time of surgery, the indocyanine dye will be injected intravenously. The investigators will use a dose of 0.5 mg/kg administered prior to VATS.
- The "filtered" near-infrared light causes the indocyanine green dye to fluoresce so that the surgeon can identify the lesions most likely to contain tumor cells.The surgeon will also look at lymph nodes to see if metastatic disease can be found in this location using this technique. The lymph nodes are processed to look for metastasis.
- Being tested
- ICG Intervention, Near Infrared Camera
- Keywords
- Indocyanine Green, Near-infrared imaging
- Medical subject headings
- Solitary Pulmonary Nodule, Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG InterventionDrug
Also called Indocyanine Green
The intervention to be administered is the drug indocyanine green.
Near Infrared CameraDevice
The intervention to detect the administered drug, indocyanine green.
| Study group | Role | What they receive |
|---|---|---|
| ICG Intervention | Experimental | The intervention to be administered is intravenous indocyanine green for intra-thoracic lesion localization and use of a near infrared camera to detect the ICG. All study subjects will receive this same intervention; there is only one arm. Receives: Drug: ICG Intervention; Device: Near Infrared Camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (safety and feasibility) of intra-operative localization of thoracic lesions following intravenous injection of indocyanine green (ICG)
In this initial proof-of-concept pilot trial for patients undergoing surgical resection of suspicious intra-thoracic lesions, the investigators will demonstrate that IV ICG is a safe and feasible method for lesion localization. The investigators will demonstrate this across a variety of intra-thoracic pathology including primary lung cancer, pulmonary metastases, mesothelioma, mediastinal tumors, and potentially infectious sources such as aspergilloma. The investigators will measure safety based on number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 5 years
Secondary outcomes (2)
Determine if intravenous ICG leads to the intra-operative detection of intra-thoracic lesions or metastatic lymph nodes not readily identifiable on conventional diagnostic imaging modalities
The investigators will determine if lesions can be identified that were not seen on pre-operative imaging either because they were too small, missed, or ill-defined. In addition, many lesions such as vague ground glass opacities, which could represent scarring or a slow growing bronchoalveolar cancer, may be targeted with IV ICG, and thus aiding in the decision to resect a given lesion. Lymph nodes that contain disease may also uptake IV ICG. If a lymphadenectomy is indicated for standard of care, NIR positive nodes will be noted.
Measured: 5 years
Determine if intravenous ICG improves surgical resection
In cases of malignancy, performing an adequate oncologic resection (i.e. negative margins) or debulking is crucial to the prognosis of a patient with an intra-thoracic malignancy. Simultaneously, a surgeon must minimize the amount of resected healthy tissue to preserve lung function. Therefore, the investigators will assess the histologic status of the margin in all patients in which the lesion was ICG positive. The investigators will also maintain records of patients undergoing IV ICG to obtain intra-operative characteristics (i.e. successful lesion localization) and long-term events (i.e. local recurrence).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start1 Feb 2016
- Primary completion28 Oct 2016
- Study completion28 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Nodule, SolitaryStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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 1/2
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yolonda Colson, Brigham and Women's Hospital
- Investigators
- Yolonda Colson, MD, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097627
- Sponsor's protocol ID
- 2015P002271
- Status last verified
- Dec 2017
- First submitted
- 13 Mar 2017
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan at this time to share any individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Indocyanine Green for Localization of Intra-thoracic Lesions
- ClinicalTrials.gov ID
- NCT03097627
- Acronym / sponsor ID
- 2015P002271
- Keywords
- Indocyanine Green, Near-infrared imaging
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 28 Oct 2016 (actual)
- Study completion
- 28 Oct 2016 (actual)
- First posted
- 31 Mar 2017 (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.
This is a clinical trial to evaluate the intravenous administration of indocyanine green (ICG) as a method of intra-thoracic lesion localization. The primary purpose is to determine if intravenous ICG allows us to identify intra-thoracic lesions.
Detailed description
- This study is designed to determine the safety and feasibility of intra-operative localization of thoracic lesions following intravenous injection of indocyanine green (ICG), determine if intravenous ICG leads to the intra-operative detection of intra-thoracic lesions or metastatic lymph nodes not readily identifiable on conventional diagnostic imaging modalities, and determine if intravenous ICG improves surgical resection.
- At the time of surgery, the indocyanine dye will be injected intravenously. The investigators will use a dose of 0.5 mg/kg administered prior to VATS.
- The "filtered" near-infrared light causes the indocyanine green dye to fluoresce so that the surgeon can identify the lesions most likely to contain tumor cells.The surgeon will also look at lymph nodes to see if metastatic disease can be found in this location using this technique. The lymph nodes are processed to look for metastasis.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICG Intervention | Experimental | Drug: ICG Intervention, Device: Near Infrared CameraThe intervention to be administered is intravenous indocyanine green for intra-thoracic lesion localization and use of a near infrared camera to detect the ICG. All study subjects will receive this same intervention; there is only one arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with intra-thoracic lesions that require resection for therapeutic or diagnostic purposes as recommended by their thoracic surgeon.
- 18 years of age or older
- Documented, signed, dated informed consent obtained prior to any study specific procedures being performed
Key exclusion criteria (4 listed)
- Subjects who do not wish to have subsequent surgical resection
- A medical condition such as uncontrolled infection or cardiac disease that, in the opinion of the treating surgeon, makes resection unreasonably hazardous for the patient
- Pre-operative spirometry that suggests the patient is at high risk or cannot undergo resection of the primary tumor.
- Iodide or seafood allergy
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 |
|---|---|---|
| ICG InterventionAlso: Indocyanine GreenThe intervention to be administered is the drug indocyanine green. | Drug | ICG Intervention |
| Near Infrared CameraThe intervention to detect the administered drug, indocyanine green. | Device | ICG Intervention |
Primary outcome
Incidence of treatment-emergent adverse events (safety and feasibility) of intra-operative localization of thoracic lesions following intravenous injection of indocyanine green (ICG)
Time frame: 5 years
In this initial proof-of-concept pilot trial for patients undergoing surgical resection of suspicious intra-thoracic lesions, the investigators will demonstrate that IV ICG is a safe and feasible method for lesion localization. The investigators will demonstrate this across a variety of intra-thoracic pathology including primary lung cancer, pulmonary metastases, mesothelioma, mediastinal tumors, and potentially infectious sources such as aspergilloma. The investigators will measure safety based on number of participants with treatment-related adverse events as assessed by CTCAE v4.0
2 secondary outcomes
Determine if intravenous ICG leads to the intra-operative detection of intra-thoracic lesions or metastatic lymph nodes not readily identifiable on conventional diagnostic imaging modalities
Time frame: 5 years
Determine if intravenous ICG improves surgical resection
Time frame: 5 years
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 12 Dec 2017.
- Individual participant dataSharing planned: No. There is no plan at this time to share any individual participant data with other researchers.
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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.
Yolonda Colson, MD, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ICG Intervention and Near Infrared Camera in people with Pulmonary Nodule, Solitary and Pulmonary Nodule, Multiple, run by Brigham and Women's Hospital 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 3 inclusion and 4 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 12 Dec 2017. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Incidence of treatment-emergent adverse events (safety and feasibility) of intra-operative localization of thoracic lesions following intravenous injection of indocyanine green (ICG) (time frame: 5 years). 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 12 Dec 2017.