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Investigational Scan for Brain Tumor Recurrence

Phase 2
Recruiting
Led By Brian J. Burkett, M.D., M.P.H.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Planned craniotomy for resection of suspected disease recurrence
Age ≥ 18 years
Must not have
Men or women of childbearing potential unwilling to employ adequate contraception
Nursing women
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 weeks
Awards & highlights

Summary

"This trial evaluates whether a specific type of imaging test called gallium-68 prostate specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT) can help

Who is the study for?
This trial is for patients with glioma, a type of brain tumor. It's specifically aimed at those who have undergone treatment and need to determine if their disease has returned or worsened. Participants should be due for an imaging assessment as part of their standard care.
What is being tested?
The study tests Ga-68 PSMA-11 PET/CT scans to see if they're better than current methods at telling the difference between tumors that are growing back or getting worse and changes caused by previous treatments in glioma patients.
What are the potential side effects?
Since this trial involves diagnostic scans, side effects may include discomfort from lying still during the scan, exposure to radiation, and possible allergic reactions to the contrast agent used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for surgery to remove a suspected recurring brain tumor.
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I am 18 years old or older.
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I had a serious brain tumor treated with chemo and radiation.
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I can provide a tissue sample for research.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am of childbearing age and not using birth control.
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I am currently breastfeeding.
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I have been treated with medication to stop new blood vessels from forming.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Concordance of the PSMA uptake levels (high vs. low)
Prostate specific membrane antigen (PSMA) uptake levels
Secondary study objectives
Incidence of adverse events

Trial Design

1Treatment groups
Experimental Treatment
Group I: Diagnostic (Ga-68 PSMA-11, PET/CT)Experimental Treatment4 Interventions
Patients receive Ga-68 PSMA-11 IV and then undergo PET/CT over 1 hour, 50-100 minutes after injection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2740
Positron Emission Tomography
2011
Completed Phase 2
~2200

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,298 Previous Clinical Trials
3,958,420 Total Patients Enrolled
Brian J. Burkett, M.D., M.P.H.Principal InvestigatorMayo Clinic in Rochester
1 Previous Clinical Trials
5 Total Patients Enrolled
~17 spots leftby Apr 2026
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