Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Investigation of Novel Surgical Imaging for Tumor Excision
NCT03686215 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 406 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lumicell, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03686215 reports 14 study locations spanning 11 distinct geographic areas — top geographies include Florida, North Carolina, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03686215?
The interventions under investigation include: Study Device Arm (COMBINATION_PRODUCT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03686215?
This trial is sponsored by Lumicell, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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