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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

MEN-301 Trial 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.

MEN-301 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

MEN-301 Trial Design

1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
Open-label, single-arm

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Gleolan for Visualization of Newly Diagnosed or Recurrent Meningioma
2020. "Gleolan for Visualization of Newly Diagnosed or Recurrent Meningioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04305470.
All > Meningioma
~24 spots leftby Apr 2025
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