Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study of Breast Cancer, sponsored by Lumicell.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Residual cancer was defined as tumor found by pathology in a therapeutic shave after the SOC surgical procedure was completed; that is, tumor that current Standard of Care (SOC) surgery failed to remove. LUM Imaging System was used during the surgery, but the assessment of the outcomes was unknown until the pathology report was available.
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 |
What the finished NCT03686215 record still lists
NCT03686215 is an interventional study that assigns participants to a tested intervention. The registered 406 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (86% lower).
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 lists 14 locations in 11 states (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.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03686215's enrollment target sits among peer trials
406 227th of 1224 higher than 998 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
RECRUITING · Phase 3
-
Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy
RECRUITING · Phase 3
-
A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer
RECRUITING · Phase 3
-
A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment.
RECRUITING · Phase 3
-
A Study of a Comprehensive Prevention Program to Reduce Lymphedema After Axillary Lymph Node Dissection in People With Breast Cancer
RECRUITING · Phase 3
-
Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease
RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06223360 · 406 participants · Phase 2
A Trial to Evaluate the Safety and Efficacy of Benfotiamine in Patients With Early Alzheimer's Disease (BenfoTeam)
- NCT06411769 · 406 participants · NA
Evidence-based Intervention to Improve Walking Engagement in El Paso, Texas
- NCT06585787 · 406 participants · Phase 3
A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)
- NCT06735534 · 407 participants · NA
Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI