Investigation of Novel Surgical Imaging for Tumor Excision
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.
Timeline
- Start
- 2019-11-04
- Primary completion
- 2021-12-09
- Completion
- 2022-05-04
Outcome
Mixed primary results
paper met prespecified thresholds for removal of residual tumor and specificity PMID 38320161 ↗
paper did not meet the prespecified threshold for sensitivity PMID 38320161 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PEGULICIANINE ACETATE | Diagnostic / imaging agent | 1 mg/kg | Intravenous |