Lung CancerNCT02423148
Pilot Study of Novel Fluorescence Endoscopic Device for Sentinel Lymph Node Mapping in Lung Cancer
A study testing Indocyanine green (ICG) and FluoSCOPE in people with Lung Cancer, run by Dana-Farber Cancer Institute.
Trial summary
This research study is studying a new imaging method that will show lymph nodes in the lung during lung cancer surgery. The name of the study intervention involved in this study is: -- The combination of the FluoSCOPE device and Indocyanine Green Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Indocyanine green (ICG) and FluoSCOPE
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2015to 3 Nov 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet the following criteria on screening examination to be eligible to participate in the study:
- Participant must have histologically confirmed lung cancer and be deemed an appropriate surgical candidate for thoracoscopic lung resection and will have consent for a sentinel lymph node mapping by their oncologic surgeon. These patients will have invasive non-small cell lung cancers for which thoracoscopic mediastinal lymph node dissection at the time of thoracoscopic lung resection is standard of care. The extent of lung resections in potential trial patients could span from sublobar resection (i.e. wedge resection) to pneumonectomy, though it is anticipated that most patients will be undergoing the most common anatomic operation for lung cancer which is lobectomy.
- All stages of lung cancer that would otherwise be undergoing thoracoscopic lung resection and mediastinal lymph node dissection would be eligible.
- Age minimum: 18 years.
- The minimum eligible subject age for this trial is 18 years. Individuals older than age 18 are typically cared for in adult oncology clinics at our institutions. Individuals under the age of 18 are excluded because safety studies including dosing or adverse event data in this population are currently not available. Essentially all of the patients operated upon for lung cancer at the BIDMC are adult men and women. Because of the nature of this disease, we do not anticipate, and will not be, enrolling any children into the study.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
- Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Participants who are receiving any other investigational agents.
- Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to indocyanine green, including those patients with a history of iodide or seafood allergy.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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- Women who are pregnant or may become pregnant, as well as those women who are breastfeeding, will be excluded from this study. Pregnant women are excluded from this study because there is unknown risk associated with ICG (US FDA Risk Category C: there are no controlled studies in women, or no studies are available in either animals or women). Because there is an unknown, but potential, risk of adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued if the mother is treated.
- Patients in whom the tumor might not be accessible for peritumoral injection of indocyanine green, e.g. small, central tumors.
- No other appropriate agent-specific exclusion criteria.
About this study
Official title: A Pilot Study of a Novel Fluorescence Endoscopic Device for Sentinel Lymph Node Mapping in Lung Cancer in Combination With Indo-Cyanine Green
This research study is studying a new imaging method that will show lymph nodes in the lung during lung cancer surgery. The name of the study intervention involved in this study is:
-- The combination of the FluoSCOPE device and Indocyanine Green
Read the detailed description
This research study is a Pilot Study, which is the first time investigators are examining this study intervention. The FDA (the U.S. Food and Drug Administration) has not approved Indocyanine Green for your specific disease, but it has been approved for other uses.
In this research study, the investigators are interested in learning how a new investigational device, the FluoSCOPE, performs in the operating room. This study will also allow the investigators to optimize the settings of the imaging system. The investigators hope that this device, along with the local injection of Indocyanine Green around the tumor, will help find the sentinel lymph nodes in real-time during the surgery to remove lung cancer.
Although this is the first time the FluoSCOPE is being used in humans, the technology of near-infrared fluorescence imaging has been used for the detection of sentinel lymph nodes of patients with breast cancer, skin cancer and lung cancer.
- Conditions
- Lung Cancer
- Being tested
- Indocyanine green (ICG), FluoSCOPE
- Keywords
- Lung Cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine green (ICG)Drug
Also called IC-Green
FluoSCOPEDevice
| Study group | Role | What they receive |
|---|---|---|
| FluoSCOPE device | Experimental | All study interventions will occur intraoperatively during the subject's planned surgery. No deviation from standard of care will be performed with the exception of the following specific interventions:-
* Intraoperative injection of indocyanine green (ICG) around tumor and imaging with the FluoSCOPE NIR endoscopic imaging system
* Treatment will be administered on an inpatient basis Receives: Drug: Indocyanine green (ICG); Device: FluoSCOPE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sentinel lymph node(s) is identified via NIR fluorescence imaging
Measured: Day one
Secondary outcomes (2)
Signal-to-background ratio
signal-to-background ratio, determined by the relationship of field of view, fluence rate, and exposure time, is at least 2:1.
Measured: Day One
Number of Participants with Adverse Events
Measured: Day One
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startMay 2015
- Primary completion3 Nov 2016
- Study completion3 Nov 2016
Why it stopped: Co-investigator left facility. Decided not to enroll patients therefore.
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.
- More trials run by Dana-Farber Cancer 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Akorn, Inc.
- Responsible party
- Principal investigator, Sidhu Gangadharan, Beth Israel Deaconess Medical Center
- Investigators
- Sidhu Gangadharan, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423148
- Sponsor's protocol ID
- 14-441
- Status last verified
- May 2018
- First submitted
- 17 Apr 2015
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of a Novel Fluorescence Endoscopic Device for Sentinel Lymph Node Mapping in Lung Cancer in Combination With Indo-Cyanine Green
- ClinicalTrials.gov ID
- NCT02423148
- Acronym / sponsor ID
- 14-441
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Co-investigator left facility. Decided not to enroll patients therefore.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Akorn, Inc.
- Study start
- May 2015
- Primary completion
- 3 Nov 2016 (actual)
- Study completion
- 3 Nov 2016 (actual)
- First posted
- 22 Apr 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.
This research study is studying a new imaging method that will show lymph nodes in the lung during lung cancer surgery. The name of the study intervention involved in this study is:
-- The combination of the FluoSCOPE device and Indocyanine Green
Detailed description
This research study is a Pilot Study, which is the first time investigators are examining this study intervention. The FDA (the U.S. Food and Drug Administration) has not approved Indocyanine Green for your specific disease, but it has been approved for other uses.
In this research study, the investigators are interested in learning how a new investigational device, the FluoSCOPE, performs in the operating room. This study will also allow the investigators to optimize the settings of the imaging system. The investigators hope that this device, along with the local injection of Indocyanine Green around the tumor, will help find the sentinel lymph nodes in real-time during the surgery to remove lung cancer.
Although this is the first time the FluoSCOPE is being used in humans, the technology of near-infrared fluorescence imaging has been used for the detection of sentinel lymph nodes of patients with breast cancer, skin cancer and lung cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FluoSCOPE device | Experimental | Drug: Indocyanine green (ICG), Device: FluoSCOPEAll study interventions will occur intraoperatively during the subject's planned surgery. No deviation from standard of care will be performed with the exception of the following specific interventions:- * Intraoperative injection of indocyanine green (ICG) around tumor and imaging with the FluoSCOPE NIR endoscopic imaging system * Treatment will be administered on an inpatient basis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants must meet the following criteria on screening examination to be eligible to participate in the study:
- Participant must have histologically confirmed lung cancer and be deemed an appropriate surgical candidate for thoracoscopic lung resection and will have consent for a sentinel lymph node mapping by their oncologic surgeon. These patients will have invasive non-small cell lung cancers for which thoracoscopic mediastinal lymph node dissection at the time of thoracoscopic lung resection is standard of care. The extent of lung resections in potential trial patients could span from sublobar resection (i.e. wedge resection) to pneumonectomy, though it is anticipated that most patients will be undergoing the most common anatomic operation for lung cancer which is lobectomy.
- All stages of lung cancer that would otherwise be undergoing thoracoscopic lung resection and mediastinal lymph node dissection would be eligible.
- Age minimum: 18 years.
- The minimum eligible subject age for this trial is 18 years. Individuals older than age 18 are typically cared for in adult oncology clinics at our institutions. Individuals under the age of 18 are excluded because safety studies including dosing or adverse event data in this population are currently not available. Essentially all of the patients operated upon for lung cancer at the BIDMC are adult men and women. Because of the nature of this disease, we do not anticipate, and will not be, enrolling any children into the study.
Key exclusion criteria (9 listed)
- Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
- Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Participants who are receiving any other investigational agents.
- Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to indocyanine green, including those patients with a history of 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 |
|---|---|---|
| Indocyanine green (ICG)Also: IC-Green | Drug | FluoSCOPE device |
| FluoSCOPE | Device | FluoSCOPE device |
Primary outcome
Sentinel lymph node(s) is identified via NIR fluorescence imaging
Time frame: Day one
2 secondary outcomes
Signal-to-background ratio
Time frame: Day One
Number of Participants with Adverse Events
Time frame: Day One
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
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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.
Sidhu Gangadharan, MD principal investigator
Beth Israel Deaconess Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Indocyanine green (ICG) and FluoSCOPE in people with Lung Cancer, run by Dana-Farber Cancer 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 6 inclusion and 9 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: withdrawn, as of the sponsor's last update on 16 May 2018. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Sentinel lymph node(s) is identified via NIR fluorescence imaging (time frame: Day one). 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 16 May 2018.