An Investigational Scan (Ga-68 PSMA-11 PET/CT) for Detection of Disease Recurrence or Progression in Patients With Glioma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

This clinical trial evaluates whether gallium-68 (Ga-68) prostate specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT) imaging is useful in differentiating between disease that has come back after a period of improvement (recurrence) or that is growing, spreading, or getting worse (progression) and treatment effect in patients with glioma. Patients with glioma undergo frequent imaging for assessment of disease status. After first-line treatment however, the correlation between imaging findings and tumor activity can be confused, and surgery is often required for definitive diagnosis. The PET/CT scanner is an imaging machine that combines 2 types of imaging in a single scan. The PET scanner detects and takes pictures of where the radioactive imaging agent (68Ga PSMA-11) has gone in the body and the CT scanner uses x-rays to take structural pictures inside the body. PSMA PET also binds to neoplastic blood vessels, including those in gliomas. This study may help researchers learn whether GA-68 PSMA-11 PET/CT is useful for improving detection of tumor recurrence or progression, as opposed to treatment effects, in patients with gliomas.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

History of World Health Organization (WHO) grade III or IV infiltrating glioma previously treated with first-line chemoradiotherapy.

MRI findings compatible with contrast-enhancing recurrent infiltrating glioma.

Planned biopsy or resection of suspected disease recurrence.

Disqualifiers

Unable to undergo a PSMA PET/CT scan (e.g. body habitus, claustrophobia).

Pregnant women

Nursing women

Men or women of childbearing potential unwilling to employ adequate contraception

Trial design

Design model

Single group

Treatments tested in this trial

  • Computed Tomography

    Procedure/Surgery

    Undergo PET/CT

  • Electronic Health Record Review

    Other intervention

    Ancillary studies

  • Ga 68 PSMA-11

    Drug

    Contrast dye given IV

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET/CT

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Diagnostic (Ga-68 PSMA-11, PET/CT)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Adverse Events (safety and tolerability)

Assessed as the percentage of patients who experience Grade 3 or higher adverse effects deemed to be at least possibly related to PSMA-11. Adverse effects will be assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.

Time frame
Up to 24 hours after 68Ga-PSMA-11 injection
2

Tolerability of PSMA positron emission tomography scan

Will assess any issues in completion of the PSMA positron emission tomography scans in these patients and summarize those in a descriptive manner.

Time frame
Up to 60 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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