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Photosensitizing Agent

Single Arm for Meningioma (MEN-301 Trial)

Phase 3
Waitlist Available
Led By Bernard Bendok, MD
Research Sponsored by NX Development Corp
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 surgery (day 1)
Awards & highlights

Summary

This trial is testing a new way to detect and remove brain tumors. It is open to people with a specific type of brain tumor, and will last 15 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~surgery (day 1)
This trial's timeline: 3 weeks for screening, Varies for treatment, and surgery (day 1) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The proportion of participants who have at least one indeterminate tissue or unexpected fluorescent End of Surgery (EOS) tissue where Gleolan-induced PpIX fluorescence status is consistent with histology.
Secondary study objectives
Diagnostic accuracy of Gleolan-induced PpIX fluorescence among indeterminate tissue and unexpected fluorescent EOS tissue locations is at least 20% greater than the diagnostic accuracy of the surgeons' assessment.
Diagnostic performance of Gleolan-induced PpIX fluorescence will be computed for indeterminate tissue biopsies, unexpected fluorescent EOS tissue biopsies.
Positive Predicted Value (PPV) of Gleolan-induced PpIX fluorescence of the single bulk tumor tissue obtained from each study participant
+2 more

Side effects data

From 2019 Phase 4 trial • 30 Patients • NCT02075671
10%
Contact Dermatitis
10%
Post-Treatment Erythema
10%
Hyperpigmentation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Levulan and Blu-U Light
Vehicle and Blu-U Light
Vehicle Only

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
Open-label, single-arm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gleolan (Aminolevulinic Acid Hydrochloride/ALA/ALA-HCI)
2020
Completed Phase 3
~110

Find a Location

Who is running the clinical trial?

NX Development CorpLead Sponsor
3 Previous Clinical Trials
233 Total Patients Enrolled
Bernard Bendok, MDPrincipal InvestigatorMayo Clinic
Walter Stummer, MDPrincipal InvestigatorUniversitätsklinikum Münster
~22 spots leftby Sep 2025
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