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Molecular Imaging Agent

LUM Imaging System for Low Grade Glioma

N/A
Waitlist Available
Led By E. Antonio Chiocca, MD, PhD
Research Sponsored by Lumicell, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 14 days post surgery
Awards & highlights

Study Summary

This study is evaluating whether a new imaging system can detect cancer in the brain.

Eligible Conditions
  • Low Grade Glioma
  • Brain Metastasis
  • Glioblastoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 14 days post surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 days post surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Correlation of fluorescence levels in normal and tumor tissue by dose of LUM015
Secondary outcome measures
Number of reported safety events

Side effects data

From 2020 Phase 2 trial • 234 Patients • NCT03321929
91%
Chromaturia
2%
Seroma
1%
Contusion
1%
Alanine aminotransferase increased
1%
Pruritus
1%
Nausea
1%
Haematoma
1%
Incision site pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
LUM Imaging System

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: 3rd Tier Dose LevelExperimental Treatment1 Intervention
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.
Group II: 2nd Tier Dose LevelExperimental Treatment1 Intervention
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.
Group III: 1st Tier Dose LevelExperimental Treatment1 Intervention
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.
Group IV: Auto-fluorescenceActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LUM Imaging System
2018
Completed Phase 2
~240

Find a Location

Who is running the clinical trial?

Lumicell, Inc.Lead Sponsor
8 Previous Clinical Trials
903 Total Patients Enrolled
E. Antonio Chiocca, MD, PhDPrincipal InvestigatorBrigham and Women's Hospital
3 Previous Clinical Trials
129 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Feasibility of the LUM Imaging System for Detection of Cancer to the Brain
2019. "Feasibility of the LUM Imaging System for Detection of Cancer to the Brain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03717142.
~6 spots leftby Jun 2025
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