Feasibility of the LUM Imaging System for Peritoneal Surface Malignancies

NCT ID: NCT03834272

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-18
• Study Completion Date: 2025-08-19

Brief 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.

Conditions

Peritoneal Metastases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

1st Tier Dose Level- LUM Imaging System

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.

Group Type: EXPERIMENTAL

LUM Imaging System

Intervention Type: COMBINATION_PRODUCT

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.

2nd Tier Dose Level- LUM Imaging System

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. Some patients may be imaged with an additional imaging device.

Group Type: EXPERIMENTAL

LUM Imaging System

Intervention Type: COMBINATION_PRODUCT

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.

3rd Tier Dose Level- LUM Imaging System

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. Some patients may be imaged with an additional imaging device.

Group Type: EXPERIMENTAL

LUM Imaging System

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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
• total bilirubin within normal institutional limits
• AST (SGOT)/ALT (SGPT) < 2.5 X institutional upper limit of normal
• Creatinine within normal institutional limits or creatinine clearance > 60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal.
• Subjects with ECOG performance status of 0 or 1.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lumicell, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Greer, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

CLP-00010

Identifier Type: -

Identifier Source: org_study_id