Intraoperative Detection of Residual Cancer in Breast Cancer
Public ClinicalTrials.gov record NCT03321929. 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
Feasibility Study Phase C: Expansion Into Multiple Institutions for Training in the Use of the LUM Imaging System for Intraoperative Detection of Residual Cancer in the Tumor Bed of Female Subjects With Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a non-randomized, open-label, multi-site study to collect safety and efficacy data on an intraoperative imaging system, the LUM Imaging System (LUM015 imaging agent in conjunction with the LUM imaging device), in identifying residual cancer in the tumor bed of female breast cancer patients. During the study, study physicians and clinical staff will complete hands-on training in anticipation of the upcoming pivotal study. Site-specific or user-specific issues related to the use of the device will be identified and addressed. Additionally, the data collected in the study will be used to continue training the tumor detection algorithm of the device. In this study, patients will be injected with LUM015 prior to surgery. The study physicians will perform lumpectomy procedures according to his or her institution's standard of care practice. After the main specimen removal is completed, the study physician will use the LUM Imaging Device to image the tumor bed. Therapeutic shaves will be removed based on the recommendation of the LUM Imaging System. Patients will be followed until their first standard of care post-operative follow-up visit.
Study identification
- NCT ID
- NCT03321929
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 234 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
- Feb 5, 2018
- Primary completion
- Apr 9, 2020
- Completion
- Apr 9, 2020
- Last update posted
- Apr 30, 2023
2018 – 2020
United States locations
- U.S. sites
- 16
- U.S. states
- 11
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of South Alabama | Mobile | Alabama | 36604 | — |
| Stanford University Medical Center | Palo Alto | California | 94304 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06511 | — |
| Comprehensive Breast Care Center | Clearwater | Florida | 33756 | — |
| Baptist MD Anderson Cancer Physicians | Jacksonville | Florida | 32207 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Lahey Hospital and Medical Center | Burlington | Massachusetts | 01805 | — |
| Beaumont Royal Oak | Royal Oak | Michigan | 48073 | — |
| Beaumont Troy | Troy | Michigan | 48098 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Novant Health | Winston-Salem | North Carolina | 27103 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Penn State Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Dallas Breast Center | Dallas | Texas | 75231 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Franciscan Breast Surgery | 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 NCT03321929, 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 Apr 30, 2023 · Synced Sep 2, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03321929 live on ClinicalTrials.gov.