NCT03097575 Bronchial NIR Image-guided Resection
| NCT ID | NCT03097575 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Massachusetts General Hospital |
| Condition | Sentinel Lymph Node |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2015-01-06 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2015-01-06 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a clinical trial to evaluate the use of peritumoral injection of near-infrared dye indocyanine green to identify lung lesions and sentinel lymph nodes. The primary purpose is to determine if the use of ICG injected via navigational bronchoscopy, CT-guided or transthoracic allows us to identify the first lymph node that drains from the tumor, and thus would be the most likely site for metastatic disease, and remove it for analysis to improve the ability to detect tumor in this node and to remove this additional site that potentially contains tumor cells. Using this intraoperative imaging technique, we aim to improve the identification of lung nodules for resection and the intraoperative identification of sentinel lymph nodes in the event that a lymphadenectomy is performed.
Eligibility Criteria
Inclusion Criteria: * Patients that have agreed to undergo video assisted thoracoscopic surgery or thoracotomy for surgical resection 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 Exclusion Criteria: * Pregnant women are excluded and women of childbearing potential without a negative pregnancy test prior to study procedures. All patients with Iodine allergies will be excluded.
Contact & Investigator
Yolonda L Colson, MD, PhD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT03097575 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sentinel Lymph Node. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03097575 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03097575 currently recruiting?
Yes, NCT03097575 is actively recruiting participants. Contact the research team at ycolson@partners.org for enrollment information.
Where is the NCT03097575 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT03097575 clinical trial?
NCT03097575 is sponsored by Massachusetts General Hospital. The principal investigator is Yolonda L Colson, MD, PhD at Massachusetts General Hospital. The trial plans to enroll 100 participants.