Feasibility of the LUM Imaging System for Detection of Cancer to the Brain

NCT03717142 | Terminated FDA Device

• 1 other identifier: CL0004
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of this study is to assess the safety and efficacy of the LUM Imaging System in imaging primary and metastatic cancer in the brain. This includes selecting a dose to determine the initial efficacy of LUM015 for the molecular imaging of low-grade gliomas, glioblastomas and cancer masses that have metastasized to the brain.

Conditions

Low Grade Glioma of Brain; Glioblastoma; Metastasis to Brain

Keywords

Fluorescence; Brain; Cancer detection

Outcome Measures

Primary Outcomes (1)

• Correlation of fluorescence levels in normal and tumor tissue by dose of LUM015

  Correlate the fluorescence levels in normal and tumor tissue from specimen imaging to the dose of LUM015 injected, or if not injected. Determine initial efficacy of LUM015 in labeling primary and metastatic cancer in the Brain by molecular imaging compared with imaging results in pathology.

  Day 1

Secondary Outcomes (1)

• Number of reported safety events

  up to 14 days post surgery

Study Arms (4)

Auto-fluorescence

NO INTERVENTION

No LUM015 injection will be given to three (3) patients, in each indication, to measure baseline tissue fluorescence. Imaging with the LUM imaging device will be performed in vivo and ex vivo on surgical tissue.

1st Tier Dose Level

EXPERIMENTAL

3 patients, in each indication, will be administered a single dose of LUM015 at 1.0 mg/kg.Imaging with the LUM imaging device will be performed in vivo and ex vivo on surgical tissue.

Combination Product: LUM Imaging System

2nd Tier Dose Level

EXPERIMENTAL

3 patients, in each indication, will be administered a single dose of LUM015 at 2.0 mg/kg. Imaging with the LUM imaging device will be performed in vivo and ex vivo on surgical tissue.

Combination Product: LUM Imaging System

3rd Tier Dose Level

EXPERIMENTAL

After an interim analysis, the dosing for the 3 patients, in each indication, will be administered a single dose of LUM015 of no greater than 3.0 mg/kg. Imaging with the LUM imaging device will be performed in vivo and ex vivo on surgical tissue.

Combination Product: LUM Imaging System

Interventions

LUM Imaging System COMBINATION_PRODUCT

Patients will be injected with one of 3 study doses of LUM015, or have no LUM015 intervention, and tissue will be imaged in vivo and ex vivo with the LUM imaging device.

1st Tier Dose Level; 2nd Tier Dose Level; 3rd Tier Dose Level

Eligibility Criteria

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

You may qualify if:

• Has radiologic imaging with a presumed diagnosis of low grade gliomas, glioblastoma/ grade III glioma or cancer metastases to the brain and must be scheduled for surgical resection
• Male or female subjects 18 years of age or older
• Subjects must have normal liver, kidney, and bone marrow function as defined below:
• Leukocytes \> 3,000/mcL
• Platelets \> 100,000/mcL
• total bilirubin within normal institutional limits
• AST (SGOT)/ALT (SGPT) \< 2.5 X institutional upper limit of normal
• Creatinine ≤ 1.5 mg/dL or creatinine clearance \> 60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal.
• Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) starting the day entering the study, and for 60 days after injection of the imaging agent
• Subjects with ECOG performance status of 0 or 1

You may not qualify if:

• Subjects previously treated with systemic therapies to treat the cancer to be removed during this clinical investigation, such as neo-adjuvant chemotherapy or hormonal therapy.
• Subjects with a known current condition of substance addiction.
• Subjects who have taken an investigational drug within 30 days of enrollment or those who have not recovered from adverse events due to pharmaceutical or diagnostic agents.
• Subjects with uncontrolled hypertension defined as persistent systolic blood pressure \> 180 mm Hg, or diastolic blood pressure \> 110 mm Hg; those subjects with known HTN should be stable within these ranges 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.
• Subjects who are pregnant or nursing.
• Subjects who are sexually active and not willing/able to use medically acceptable forms of contraception upon entering the study.
• HIV-positive individuals on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with LUM015.

Sponsors & Collaborators

• Lumicell, Inc.: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• E. Antonio Chiocca, MD, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: October 22, 2018
• First Posted: October 24, 2018
• Study Start: May 3, 2019
• Primary Completion: September 13, 2023
• Study Completion: June 14, 2024
• Last Updated: January 15, 2025

Record last verified: 2024-03

Locations

US (1)