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Completed Phase 3 Interventional Results available

Gleolan for Visualization of Newly Diagnosed or Recurrent Meningioma

ClinicalTrials.gov ID: NCT04305470

Public ClinicalTrials.gov record NCT04305470. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 5:34 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3 Multicenter Study of Gleolan (Aminolevulinic Acid Hydrochloride) to Enhance Visualization of Tumor in Patients With Newly Diagnosed or Recurrent Meningiomas

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04305470
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
NX Development Corp
Industry
Enrollment
108 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 28, 2020 (Actual)
Primary completion
Nov 7, 2022 (Actual)
Completion
Dec 13, 2022 (Actual)
Last update posted
May 18, 2026

2020 – 2022

United States locations

U.S. sites
15
U.S. states
11
U.S. cities
15
Facility City State ZIP Site status
Mayo Clinic Phoenix Arizona 85054 —
University of California San Diego La Jolla California 92093 —
Keck Hospital of USC Los Angeles California 90033 —
Providence St. Joseph Hospital Orange California 92868 —
Swedish Medical Center Englewood Colorado 80113 —
University of Miami Coral Gables Florida 33136 —
Baptist Health South Florida Miami Florida 33176 —
Southern Illinois University Springfield Illinois 62702 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Henry Ford Health System Detroit Michigan 48202 —
Mayo Clinic Rochester Rochester Minnesota 55905 —
NYU Langone Health Brooklyn New York 11220 —
University of Pennsylvania- Penn Medicine Philadelphia Pennsylvania 19104 —
UPMC Pittsburgh Pennsylvania 15213 —
MD Anderson Houston Texas 77030 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04305470, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 18, 2026 · Synced Oct 21, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04305470 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →