LUM Imaging for Peritoneal Tumors

Recruiting in Palo Alto (17 mi)

Overseen ByJonathan Greer, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Lumicell, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?The objective of this feasibility study is to assess the initial safety and efficacy of the LUM Imaging System for in vivo imaging of metastases to the peritoneum from primary gastrointestinal cancer, ovarian cancer and mesothelioma. This feasibility study consists of two parts: (a) a dose escalation phase to select the optimal dose followed by (b) enrollment of additional patients to develop the tumor detection algorithm.

Eligibility Criteria

This trial is for adults over 18 with peritoneal metastases from gastrointestinal, ovarian, or mesothelioma cancers. They must be scheduled for surgery and have normal organ/marrow function. Excluded are those on recent investigational drugs, pregnant/nursing individuals, uncontrolled hypertension or illness, HIV-positive on antiretrovirals, allergy to contrast agents/PEG.

Participant Groups

The LUM Imaging System is being tested for its ability to safely and effectively image cancer spread to the peritoneum in real-time during surgery. The study has two parts: a dose-finding phase followed by patient enrollment to refine the tumor detection algorithm.

4Treatment groups

Experimental Treatment

Group I: Optimal Dose ArmExperimental Treatment1 Intervention

12 patients will receive LUM015 at the dose and timepoint selected based on the analysis of the data

Group II: 3rd Tier Dose Level- LUM Imaging SystemExperimental Treatment1 Intervention

6 patients will be administered a single dose of LUM015 at 2.0 mg/kg. Imaging with the LUM imaging device will be performed in vivo on surgical tissue.

Group III: 2nd Tier Dose Level- LUM Imaging SystemExperimental Treatment1 Intervention

9 patients will be administered a single dose of LUM015 at 1.5 mg/kg. Imaging with the LUM imaging device will be performed in vivo on surgical tissue.

Group IV: 1st Tier Dose Level- LUM Imaging SystemExperimental Treatment1 Intervention

3 patients will be administered a single dose of LUM015 at 1.0 mg/kg. Imaging with the LUM imaging device will be performed in vivo on surgical tissue.