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NCT03321929 · ClinicalTrials.gov registry record · Phase 2
Intraoperative Detection of Residual Cancer in Breast Cancer
A Phase 2 study, sponsored by Lumicell.
- Completed
- Registry status
- Phase 2
- Development phase
- 234
- Enrollment target
NCT03321929 is a Phase 2 study that has completed, run by Lumicell. The registered enrollment target is 234 participants.
The verdict
NCT03321929, a Phase 2 study, has completed, sponsored by Lumicell.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 234 participants
- Enrollment target
Study Summary
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.
Interventions
- COMBINATION_PRODUCT LUM Imaging System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 234 participants |
| Start Date | 2018-02-06 |
| Est. Completion | 2020-04-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03321929
The ClinicalTrials.gov registry entry for NCT03321929 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 234 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lumicell, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which LUM Imaging System is the first listed.
NCT03321929 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03321929 about?
NCT03321929 is a clinical study titled "Intraoperative Detection of Residual Cancer in Breast Cancer". 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. ...
What is the current status of trial NCT03321929?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 234 participants. The study started on 2018-02-06. Estimated completion is 2020-04-10.
What interventions are being tested in trial NCT03321929?
The interventions under investigation include: LUM Imaging System (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03321929?
This trial is sponsored by Lumicell, which has 8 total clinical trials registered on ClinicalTrials.gov.
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