Clinical trial NCT06444412: An Investigational Scan (Ga-68 PSMA-11 PET/CT) for Detection of Disease Recurrence or Progression in Patients with Glioma
Official title: GA-68 PSMA-11 PET to Evaluate Malignant Glioma Recurrence - a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: WHO Grade 3 Glioma
WHO Grade 4 Glioma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: PRIMARY OBJECTIVE:

I. To assess uptake of Ga-68 labeled PSMA-11 in regions of high tumor cell density (tumor recurrence) and low tumor cell density/treatment effect to determine whether PSMA-11 uptake differs significantly between true tumor progression versus (vs.) in radiation treatment effects.

SECONDARY OBJECTIVE:

I. To evaluate the immediate safety and tolerability of PSMA PET in patients with glioma.

EXPLORATORY OBJECTIVES:

I. To identify optimal maximum standardized uptake value (SUVmax) thresholds for differentiating viable tumor from treatment effect.

II. To perform a radiology-pathology correlation of PSMA uptake at PET with tumor PSMA immunohistochemistry (IHC) immunostaining, tumor pathology features, and signal and enhancement characteristics at magnetic resonance imaging (MRI) (no research MRI will be obtained, based on MRI images obtained for clinical use).

III. To evaluate the added diagnostic value of gallium Ga 68 (Ga-68 PSMA-11) PET beyond MRI (using information from a clinical MRI\[s\] obtained prior to enrollment in the study) for detecting viable enhancing tumor from treatment effects.

OUTLINE:

Patients receive Ga-68 PSMA-11 intravenously (IV) and then undergo PET/CT over 1 hour, 50-100 minutes after injection.

Eligibility criteria: Inclusion Criteria:

* 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 craniotomy for resection of suspected disease recurrence.
* Willing to sign release of information for any radiation and/or follow-up records.
* Ability to provide informed written consent.
* Ability to provide tissue for mandatory correlative research component.

Exclusion Criteria:

* Previous treatment with antiangiogenic therapy (e.g. bevacizumab).
* Unable to undergo a PSMA PET/CT scan (e.g. body habitus, claustrophobia).
* Any of the following:

  * Pregnant women
  * Nursing women
  * Men or women of childbearing potential unwilling to employ adequate contraception

Primary outcomes:
measure: Prostate specific membrane antigen (PSMA) uptake levels
timeFrame: Up to 2 weeks
measure: Concordance of the PSMA uptake levels (high vs. low)
timeFrame: Up to 2 weeks
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: Up to 2 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Brian J. Burkett, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: