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Multispectral Bimodal Fluorescence Guided Surgery of High-grade Glioma With Cetuximab-800CW and 5-ALA (5-aminolevulinic Acid)

NCT05929456 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2023-07-03

No results posted yet for this study

Summary

The MIRROR study is a prospective, single center phase I feasibility and dose finding study in patients with high-grade glioma, to establish the safety, feasibility, and optimal dosage of Cetuximab-IRDye800CW for fluorescence guided surgery, in comparison to the standard of care (SOC), 5-ALA fluorescent imaging agent. The main research objectives of this study are:

1. To determine the optimal dosage of Cetuximab-IRDye800CW for fluorescence guided surgery
2. To assess the safety and tolerability
3. To correlate fluorescent signals measured by in vivo multispectral imaging with Cetuximab-IRDye800CW and 5-ALA with those measured by ex vivo imaging

The study population will consist of patients, aged ≥18 years, diagnosed with high-grade glioma and scheduled for surgery.

Conditions

Interventions

DRUG

Cetuximab-IRDye800

patients will receive a single IV injection of Cetuximab-IRDye800CW 2-4 days prior to surgert. The IMP (Investigational medicinal product)/tracer will be used for fluorescence guided surgery.

Sponsors & Collaborators

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Rob Groen, MD, PhD · University Medical Center Groningen

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-05
Primary Completion
2024-10-01
Completion
2025-01-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05929456 on ClinicalTrials.gov