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Feasibility of the LUM Imaging System for Peritoneal Surface Malignancies

NCT03834272 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-01-16

No results posted yet for this study

Summary

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 a dose escalation phase to select the optimal dose.

Conditions

  • Peritoneal Metastases

Interventions

COMBINATION_PRODUCT

LUM Imaging System

Patients will be injected with one of 3 study doses of LUM015 and tissue will be imaged in vivo with the LUM imaging device. Some patients may be imaged with an additional imaging device.

Sponsors & Collaborators

  • Lumicell, Inc.

    lead INDUSTRY

Principal Investigators

  • Jonathan Greer, MD · Massachusetts General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-18
Primary Completion
2025-08-19
Completion
2025-08-19
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03834272 on ClinicalTrials.gov