Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Clinical Trial Phase 1 study, sponsored by Lumicell.
NCT03441464 is a Phase 1 study that was terminated before completion, run by Lumicell. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Correlate the fluorescence levels in tumor tissue from ex-vivo specimen imaging to the dose of LUM015 injected.
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 |
Why NCT03441464 stopped before completion
NCT03441464 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which LUM Imaging System is the first listed.
NCT03441464 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03441464's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI