Investigation of Novel Surgical Imaging for Tumor Excision
Public ClinicalTrials.gov record NCT03686215. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Pivotal Study of the LUM Imaging System for Assisting Intraoperative Detection of Residual Cancer in the Tumor Bed of Female Patients With Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03686215
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 406 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 4, 2019 (Actual)
- Primary completion
- Dec 9, 2021 (Actual)
- Completion
- May 4, 2022 (Actual)
- Last update posted
- Aug 24, 2023
2019 – 2022
United States locations
- U.S. sites
- 14
- U.S. states
- 11
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of South Alabama Mitchell Cancer Institute | Mobile | Alabama | 36604 | — |
| HonorHealth Research Institute | Scottsdale | Arizona | 85258 | — |
| Stanford Hospital and Clinics | Palo Alto | California | 94304 | — |
| Morton Plant Mease Health Care Oncology Research | Clearwater | Florida | 33756 | — |
| Baptist MD Anderson Cancer Center | Jacksonville | Florida | 32207 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Comprehensive Breast Care Center/Beaumont Health | Royal Oak | Michigan | 48073 | — |
| Duke Cancer Center | Durham | North Carolina | 27710 | — |
| Novant Health Salem Surgical Associates | Winston-Salem | North Carolina | 27103 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| CHI Franciscan Research Center | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03686215, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 24, 2023 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03686215 live on ClinicalTrials.gov.