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NCT03441464 · ClinicalTrials.gov registry record · Phase 1
Feasibility of the LUM Imaging System for Detection of Prostate Cancer
A Phase 1 study, sponsored by Lumicell.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT03441464 is a Phase 1 study that was terminated before completion, run by Lumicell. The registered enrollment target is 9 participants.
The verdict
NCT03441464, a Phase 1 study, was terminated before completion, sponsored by Lumicell.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
The primary objective of this feasibility study is to determine if administration of LUM015 will result in positive fluorescence of tumor tissue from ex vivo specimen imaging with the LUM Imaging device from patients undergoing radical prostatectomy for prostate cancer. Both normal tissue and tumor tissue will be imaged and analyzed. The LUM Imaging System is a portable combination product consisting of an imaging device and an imaging agent (LUM015). Patients with an established diagnosis of prostate cancer and who are eligible for radical prostatectomy will be screened. Eligible patients will be enrolled and on the day of their planned surgery, LUM015 will be administered 2-6 hours prior to surgery. Patients will undergo radical prostatectomy 2-6 hours after LUM015 administration. All surgical specimens will be imaged with the LUM imaging device and have routine diagnostic assessment. Patients will be monitored for adverse events from time of injection through the first standard of care post-surgical follow-up visit.
Interventions
- COMBINATION_PRODUCT LUM Imaging System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2019-03-20 |
| Est. Completion | 2021-02-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03441464
The ClinicalTrials.gov registry entry for NCT03441464 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 9 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.
NCT03441464 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03441464 about?
NCT03441464 is a clinical study titled "Feasibility of the LUM Imaging System for Detection of Prostate Cancer". The primary objective of this feasibility study is to determine if administration of LUM015 will result in positive fluorescence of tumor tissue from ex vivo specimen imaging with the LUM Imaging device from patients undergoing radical prostatectomy for prostate cancer. Both normal tissue and tumor ...
What is the current status of trial NCT03441464?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2019-03-20. Estimated completion is 2021-02-11.
What interventions are being tested in trial NCT03441464?
The interventions under investigation include: LUM Imaging System (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03441464?
This trial is sponsored by Lumicell, which has 8 total clinical trials registered on ClinicalTrials.gov.
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