Clinical trial · Interventional
Feasibility of the LUM Imaging System for Detection of Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Interim analysis indicated a change in study design to collect in vivo data
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasm, Residual | Neoplasm | CURATED_BROADER | 0.78 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LUM Imaging System | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- 1st Tier Dose Level
- description
- 3 patients administered single dose of LUM015 at 0.5 mg/kg. Imaging with the LUM imaging device will be performed ex vivo on resected tissue.
- interventionNames
- Combination Product: LUM Imaging System
- type
- EXPERIMENTAL
- label
- 2nd Tier Dose Leel
- description
- 3 patients administered single dose of LUM015 at 1.0 mg/kg. Imaging with the LUM imaging device will be performed ex vivo on resected tissue.
- interventionNames
- Combination Product: LUM Imaging System
- type
- EXPERIMENTAL
- label
- 3rd Tier Dose Level
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with clinically localized or locally advanced prostate cancer and scheduled for radical prostatectomy * Age 40 years or older * Able and willing to follow study procedures and instructions * Received and signed informed consent form * Otherwise healthy except for diagnosis of cancer * Normal organ and marrow function as defined below: * Hemoglobin 13.9 - 16.3 g/dL * Leukocytes 4500 - 11,000 uL * Platelets 150,000 - 450,000 uL * Total bilirubin within normal institutional limits * AST (SGOT)/ALT (SGPT) within normal institutional limits * Creatinine within normal institutional limits or creatinine clearance within normal institutional limits * ECOG performance status of 0 or 1 Exclusion Criteria: * Known current substance addiction * Have taken an investigational drug within 30 days of enrollment * Received methylene blue prior to tissue excision * QT Interval \> 480ms * Have not recovered from an adverse event due to pharmaceutical or diagnostic agent * Uncontrolled hypertension defined as persistent systolic blood pressure \> 180 mm Hg, or diastolic blood pressure \> 100 mm Hg; subjects with known HTN should be under these values while under pharmaceutical therapy * History of allergic reaction attributed to drugs containing polyethylene glycol (PEG). * History of allergic reaction to any oral or intravenous contrast agents. * Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, COPD or asthma requiring hospitalization within the past 12 months, or psychiatric illness/social situations that would limit compliance with study requirements * Sexually active subjects unwilling/unable to use medically acceptable forms of contraception during study participation * HIV-positive subjects on combination antiretroviral therapy * Investigator feels subject's participation is not in the best interest of the subject * Previously treated with local or systemic therapies to treat prostate cancer
References
Publications (0)
Data not yet available