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COMPLETEDPHASE1/PHASE2

Feasibility of the LUM Imaging System for Peritoneal Surface Malignancies

Feasibility of the LUM Imaging System for Detection of Peritoneal Surface Malignancies

NCT03834272•Lumicell, Inc.

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.

Detailed Description

Subjects will be recruited and screened at a single institution, Massachusetts General Hospital. All subjects will have an established diagnosis of metastases to the peritoneum from primary colonic, appendiceal, or ovarian cancer or mesothelioma and are scheduled for surgical debulking. This study consists of a dose escalation and imaging timepoint evaluation. 18 patients will be enrolled into this study.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects must have histologically or cytologically confirmed metastases to the peritoneum from gastrointestinal cancer, ovarian cancer or mesothelioma prior to surgery.
•Subjects must be scheduled for surgical resection.
•Age of 18 years or older.
•Subjects must be able and willing to follow study procedures and instructions.
•Subjects must have received and signed an informed consent form.
•Subjects must be otherwise healthy except for the diagnosis of cancer, as per the criteria listed below.
•Subjects must have normal organ and marrow function as defined as:
•* Leukocytes \> 3,000/mcL
•* Absolute neutrophil count \> 1,500/mcL
•* Platelets \> 100,000/mcL
+4 more criteria

Exclusion Criteria

•Subjects who are pregnant or nursing at the time of diagnosis.
•Subjects who are sexually active and not willing/able to use medically acceptable forms of contraception (hormonal or barrier method of birth control, abstinence) upon entering the study and for 60 days after injection of LUM015.
•Subjects who have taken an investigational drug within 30 days of enrollment.
•Subjects who have not recovered from adverse events due to other pharmaceutical or diagnostic agents.
•Subjects with uncontrolled hypertension defined as persistent systolic blood pressure \> 180 mm Hg, or diastolic blood pressure \> 100 mm Hg; those 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.
•HIV-positive individuals on combination antiretroviral therapy are ineligible.
•Any subject for whom the investigator feels participation is not in the best interest of the subject.

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Key Dates

Start Date

March 18, 2019

Primary Completion Date

August 19, 2025

Completion Date

August 19, 2025

Last Updated

January 16, 2026

Enrollment

ACTUAL participants

Conditions

Peritoneal Metastases

Interventions

LUM Imaging System

COMBINATION_PRODUCT

Systemic Application of Cadonilimab, LM-302, and S-1 Combined With Intraperitoneal Infusion of Paclitaxel for the Treatment of Claudin 18.2-positive Gastric Cancer With Peritoneal Metastasis

NCT06519591

Gastric Cancer Stage IVPeritoneal Metastases

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RECRUITING

Prediction of Peritoneal Metastasis for Gastric Cancer Based on Radiomics

NCT05722275

Gastric CancerPeritoneal Metastases

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Feasibility of the LUM Imaging System for Peritoneal Surface Malignancies

Inclusion Criteria

Exclusion Criteria

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Prediction of Peritoneal Metastasis for Gastric Cancer Based on Radiomics

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