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LUM Imaging for Peritoneal Tumors

Phase 1 & 2

Recruiting

Led By James C Cusack, MD

Research Sponsored by Lumicell, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 weeks post surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new imaging system to see if it can detect cancer in the abdomen. The system will be given to patients in two parts: first to see what dose is safe, then to a larger group of people to test its effectiveness.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of the LUM Imaging System aren't detailed here, potential risks may include reactions related to imaging agent administration such as allergic reactions or issues due to contrast sensitivity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 weeks post surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 weeks post surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 weeks post surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Initial efficacy of LUM015 in labeling peritoneal surface malignancies by molecular imaging by comparing imaging results with pathology

Secondary study objectives

Number of patients with reported adverse events

Side effects data

From 2020 Phase 2 trial • 234 Patients • NCT03321929

91%

Chromaturia

Seroma

Contusion

Alanine aminotransferase increased

Pruritus

Nausea

Haematoma

Incision site pain

100%

80%

60%

40%

20%

Study treatment Arm

LUM Imaging System

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LUM Imaging System

2018

Completed Phase 2

~240

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