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NCT03097575 · ClinicalTrials.gov registry record · Phase 1
Bronchial NIR Image-guided Resection
A Phase 1 study of Sentinel Lymph Node, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT03097575: Recruiting Phase 1 study of Sentinel Lymph Node, sponsored by Massachusetts General Hospital.
NCT03097575 is a Phase 1 study of Sentinel Lymph Node that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 100 participants, below the 311-participant average among 5 other Sentinel Lymph Node trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03097575, a Phase 1 study of Sentinel Lymph Node, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
In this initial proof-of-concept pilot trial for patients undergoing surgical resection of a suspicious lung lesion, we will translate the new technology of NIR-imaging to the OR and assess safety and feasibility of ICG delivery, optimize the ability to "NIR tattoo" and visualize lung lesions for targeted resection vs NIR-highlighted segmental resections, assess histology of the surgical margin and determine lesional characteristics which predict successful NIR imaging. Safety and feasibility wi
Conditions Studied
Interventions
- DRUG ICG Intervention
- DEVICE Near Infrared Imaging
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2015-01-06 |
| Est. Completion | 2029-01-01 |
| Phase | Phase 1 |
What NCT03097575 shows while recruiting
NCT03097575 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 311-participant average among 5 other Sentinel Lymph Node trials with a reported enrollment target (68% lower).
The record links to 1 condition, with Sentinel Lymph Node appearing as the primary indexed condition, and to 2 interventions - of which ICG Intervention is the first listed.
NCT03097575 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03097575 about?
NCT03097575 is a clinical study titled "Bronchial NIR Image-guided Resection". 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 identi...
What is the current status of trial NCT03097575?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2015-01-06. Estimated completion is 2029-01-01.
What conditions does trial NCT03097575 study?
This clinical trial studies the following conditions: Sentinel Lymph Node.
What interventions are being tested in trial NCT03097575?
The interventions under investigation include: ICG Intervention (DRUG), Near Infrared Imaging (DEVICE).
Who is sponsoring clinical trial NCT03097575?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03097575 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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