Feasibility of the LUM Imaging System for Peritoneal Surface Malignancies

NCT03834272 | Completed Phase 1 FDA Drug FDA Device

• 1 other identifier: CLP-00010
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Peritoneal Metastases

Keywords

Gastrointestinal Cancer; Ovarian Cancer; Mesothelioma; Peritoneal surface malignancies

Outcome Measures

Primary Outcomes (1)

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

  Correlate the fluorescence levels in tumor tissue imaging to the dose of LUM015 injected.

  1 Day

Secondary Outcomes (1)

• Number of patients with reported adverse events

  up to 5 weeks post surgery

Study Arms (3)

1st Tier Dose Level- LUM Imaging System

EXPERIMENTAL

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.

Combination Product: LUM Imaging System

2nd Tier Dose Level- LUM Imaging System

EXPERIMENTAL

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.

Combination Product: LUM Imaging System

3rd Tier Dose Level- LUM Imaging System

EXPERIMENTAL

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.

Combination Product: LUM Imaging System

Interventions

LUM Imaging System 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.

1st Tier Dose Level- LUM Imaging System; 2nd Tier Dose Level- LUM Imaging System; 3rd Tier Dose Level- LUM Imaging System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lumicell, Inc.: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Ovarian Neoplasms; Mesothelioma; Peritoneal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial; Abdominal Neoplasms; Peritoneal Diseases

Study Officials

• Jonathan Greer, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose Escalation

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 7, 2019
• Study Start: March 18, 2019
• Primary Completion: August 19, 2025
• Study Completion: August 19, 2025
• Last Updated: January 16, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)