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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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Initial efficacy of LUM015 in labeling peritoneal surface malignancies by molecular imaging by comparing imaging results with pathology
Secondary outcome measures
Number of patients with reported adverse events

Side effects data

From 2020 Phase 2 trial • 234 Patients • NCT03321929
91%
Chromaturia
2%
Seroma
1%
Pruritus
1%
Contusion
1%
Alanine aminotransferase increased
1%
Nausea
1%
Haematoma
1%
Incision site pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
LUM Imaging System

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

Find a Location

Who is running the clinical trial?

Lumicell, Inc.Lead Sponsor
8 Previous Clinical Trials
909 Total Patients Enrolled
James C Cusack, MDPrincipal InvestigatorMassachusetts General Hospital

Media Library

LUM Imaging System Clinical Trial Eligibility Overview. Trial Name: NCT03834272 — Phase 1 & 2
Metastases Research Study Groups: Optimal Dose Arm, 3rd Tier Dose Level- LUM Imaging System, 2nd Tier Dose Level- LUM Imaging System, 1st Tier Dose Level- LUM Imaging System
Metastases Clinical Trial 2023: LUM Imaging System Highlights & Side Effects. Trial Name: NCT03834272 — Phase 1 & 2
LUM Imaging System 2023 Treatment Timeline for Medical Study. Trial Name: NCT03834272 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment size of this research study?

"Affirmative. Per the clinicaltrials.gov, this research protocol is currently searching for participants; it was published on March 18th 2019 and updated most recently on September 10th 2021. The trial requires a total of 18 volunteers to be enrolled at 1 medical centre."

Answered by AI

Is this research initiative still open to participants?

"According to clinicaltrials.gov, this experiment is still recruiting volunteers who are willing to participate in the trial. It was originally posted on March 18th 2019 and has been edited as recently as September 10th 2021."

Answered by AI
~7 spots leftby Dec 2025