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Gleolan for Visualization of Newly Diagnosed or Recurrent Meningioma

NCT04305470 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2026-05-18

Study results available
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Summary

This Phase 3 open-label single-arm study is designed to investigate the safety, diagnostic performance, and clinical usefulness of Gleolan for the real time detection and visualization of meningiomas during tumor resection surgery. The study is planned to run for 15 months with individual study participation lasting for approximately 2 months.

Conditions

  • Meningioma

Interventions

DRUG

Gleolan

One time oral dose on day of surgery (20 mg/kg bodyweight)

Sponsors & Collaborators

  • NX Development Corp

    lead INDUSTRY

Principal Investigators

  • Walter Stummer, MD · Universitätsklinikum Münster

  • Bernard Bendok, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-28
Primary Completion
2022-11-07
Completion
2022-12-13
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Germany

Study Locations

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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 NCT04305470 on ClinicalTrials.gov