Feasibility of the LUM Imaging System for Detection of Prostate Cancer
Public ClinicalTrials.gov record NCT03441464. 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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03441464
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 9 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years and older
- Sex
- Male
- 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
- Mar 19, 2019
- Primary completion
- Feb 10, 2021
- Completion
- Feb 10, 2021
- Last update posted
- Feb 24, 2022
2019 – 2021
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10044 | — |
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 NCT03441464, 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 Feb 24, 2022 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03441464 live on ClinicalTrials.gov.