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NCT05929456: MIRROR

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

Status unknown Phase 1 Last updated 3 July 2023
What this trial tests

Phase 1 trial testing Cetuximab-IRDye800 in Glioblastoma in 21 participants. Status unknown.

Timeline
5 May 2023
Primary endpoint
1 October 2024
1 January 2025

Quick facts

Lead sponsorUniversity Medical Center Groningen
PhasePhase 1
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment21
Start date5 May 2023
Primary completion1 October 2024
Estimated completion1 January 2025
Sites1 location across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

University Medical Center Groningen

Who can join

18 and older, any sex, with Glioblastoma or High-grade Glioma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Increasing the Dye Payload of Cetuximab-IRDye800CW Enables Photodynamic Therapy.
    Nguyen A, Bhandari C, Keown M, Malkoochi A, et al · · 2024 · cited 6× · PMID 38861020 · DOI 10.1021/acs.molpharmaceut.4c00046

Verify or expand the search:

Other trials of Cetuximab-IRDye800

Trials testing the same drug.

Other recruiting trials for Glioblastoma

Currently open trials in the same condition.

Other University Medical Center Groningen trials

Trials by the same sponsor.

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Data sources for this page

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