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NCT03686215 · ClinicalTrials.gov registry record · Phase 3
Investigation of Novel Surgical Imaging for Tumor Excision
A Phase 3 study of Breast Cancer, sponsored by Lumicell.
- Completed
- Registry status
- Phase 3
- Development phase
- 406
- Enrollment target
- 14
- Study locations
NCT03686215 is a Phase 3 study of Breast Cancer that has completed, run by Lumicell. The registered enrollment target is 406 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (86% lower). The trial reports 14 study locations across 11 states.
The verdict
NCT03686215, a Phase 3 study of Breast Cancer, has completed, sponsored by Lumicell.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 406 participants
- Enrollment target
- 14
- Study locations
Study Summary
This is a multi-center, two-arm randomized, blinded pivotal study to demonstrate the safety and efficacy of the LUM Imaging System (LUM015 imaging agent in conjunction with the LUM Imaging Device and decision software), in identifying residual cancer in the lumpectomy bed of female breast cancer patients undergoing breast surgery in order to assist surgeons in reducing the rates of positive margins. All enrolled subjects will be injected with LUM015 prior to surgery. Surgeons are blinded to whether a participant will be randomized into the device arm until after the standard of care lumpectomy is complete. Participants will then be randomized to receiving the device. Therapeutic (LUM guided) shaves will be removed based on the guidance of the LUM Imaging System. Patients will be followed until their first standard of care post-operative follow-up visit.
Conditions Studied
Interventions
- COMBINATION_PRODUCT Study Device Arm
Study Locations (14)
Florida
- Morton Plant Mease Health Care Oncology Research - Clearwater
- Baptist MD Anderson Cancer Center - Jacksonville
- Moffitt Cancer Center - Tampa
North Carolina
- Duke Cancer Center - Durham
- Novant Health Salem Surgical Associates - Winston-Salem
Alabama
- University of South Alabama Mitchell Cancer Institute - Mobile
Arizona
- HonorHealth Research Institute - Scottsdale
California
- Stanford Hospital and Clinics - Palo Alto
Massachusetts
- Massachusetts General Hospital - Boston
Michigan
- Comprehensive Breast Care Center/Beaumont Health - Royal Oak
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 406 participants |
| Start Date | 2019-11-04 |
| Est. Completion | 2022-05-04 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03686215
The ClinicalTrials.gov registry entry for NCT03686215 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 406 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (86% lower). The listed sponsor is Lumicell, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Study Device Arm is the first listed.
NCT03686215 reports 14 study locations spanning 11 distinct geographic areas - top geographies include Florida, North Carolina, Alabama.
Frequently Asked Questions
What is clinical trial NCT03686215 about?
NCT03686215 is a clinical study titled "Investigation of Novel Surgical Imaging for Tumor Excision". This is a multi-center, two-arm randomized, blinded pivotal study to demonstrate the safety and efficacy of the LUM Imaging System (LUM015 imaging agent in conjunction with the LUM Imaging Device and decision software), in identifying residual cancer in the lumpectomy bed of female breast cancer pat...
What is the current status of trial NCT03686215?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 406 participants. The study started on 2019-11-04. Estimated completion is 2022-05-04.
What conditions does trial NCT03686215 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT03686215?
The interventions under investigation include: Study Device Arm (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03686215?
This trial is sponsored by Lumicell, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03686215 being conducted?
This trial has 14 study locations across Alabama, Arizona, California, Florida, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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