Trial Title:
An Investigational Scan (Ga-68 PSMA-11 PET/CT) for Detection of Disease Recurrence or Progression in Patients with Glioma
NCT ID:
NCT06444412
Condition:
WHO Grade 3 Glioma
WHO Grade 4 Glioma
Conditions: Official terms:
Glioma
Recurrence
Edetic Acid
Gallium 68 PSMA-11
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo PET/CT
Arm group label:
Diagnostic (Ga-68 PSMA-11, PET/CT)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
Computerized Tomography (CT) scan
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Ancillary studies
Arm group label:
Diagnostic (Ga-68 PSMA-11, PET/CT)
Intervention type:
Drug
Intervention name:
Ga 68 PSMA-11
Description:
Contrast dye given IV
Arm group label:
Diagnostic (Ga-68 PSMA-11, PET/CT)
Other name:
(68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
Other name:
(68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC
Other name:
(68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
Other name:
(68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
Other name:
(68Ga)Glu-urea-Lys(Ahx)-HBED-CC
Other name:
68Ga-DKFZ-PSMA-11
Other name:
68Ga-HBED-CC-PSMA
Other name:
68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
Other name:
68Ga-PSMA
Other name:
68Ga-PSMA-11
Other name:
68Ga-PSMA-HBED-CC
Other name:
[68Ga] Prostate-specific Membrane Antigen 11
Other name:
[68Ga]GaPSMA-11
Other name:
AAA 517
Other name:
AAA-517
Other name:
AAA517
Other name:
Ga PSMA
Other name:
Ga-68 labeled DKFZ-PSMA-11
Other name:
Ga-68 labeled PSMA-11
Other name:
Ga 68 PSMA-11, Intravenous Solution
Other name:
Gallium Ga 68 PSMA-11
Other name:
Gallium Ga 68-labeled PSMA-11
Other name:
Gallium-68 PSMA
Other name:
Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
Other name:
GaPSMA
Other name:
PSMA-HBED-CC GA-68
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET/CT
Arm group label:
Diagnostic (Ga-68 PSMA-11, PET/CT)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron emission tomography (procedure)
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Brian J. Burkett, MD, MPH
Start date:
July 26, 2024
Completion date:
April 30, 2026
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06444412
https://www.mayo.edu/research/clinical-trials
