An Investigational Scan (Ga-68 PSMA-11 PET/CT) for the Detection of Therapy Response in Patients With Metastatic Adenoid Cystic Carcinoma

Pilot Study Evaluating PSMA PET For Metastatic Adenoid Cystic Carcinoma

This phase II trial tests whether gallium-68 (Ga-68) prostate specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT) imaging is useful for detecting therapy response in patients with adenoid cystic carcinoma (salivary gland cancer) that has spread from where it first started (primary site) to other places in the body (metastatic). The PET scan detects and takes pictures of where the radioactive imaging agent (68Ga PSMA-11) has gone in the body and the CT scan uses x-rays to create images of the bones and internal organs within the body. Combining a PET scan with a CT scan can help make the images easier to interpret. This study may help researchers learn whether GA-68 PSMA-11 PET/CT is useful for detecting treatment response and guiding treatment decisions in patients with metastatic adenoid cystic carcinoma.

Study Overview

• Status: Completed
• Conditions: Metastatic Adenoid Cystic Carcinoma
• Intervention / Treatment: Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Other: Electronic Health Record Review; Drug: Ga-68 PSMA-11

Detailed Description

PRIMARY OBJECTIVES:

I. Evaluate the feasibility of serial Ga-68 PSMA PET/CT for response assessment in metastatic adenoid cystic carcinoma.

II. Assess the correlation of PSMA PET/CT response assessment with serum extracellular vesical (EV) PSMA levels for patients undergoing treatment for metastatic adenoid cystic carcinoma.

OUTLINE:

Patients receive Ga-68 PSMA-11 intravenously (IV) and then undergo PET/CT 50-70 minutes after injection at baseline and approximately 12-20 weeks during investigational therapy.

After completion of study intervention, patients are followed up at 1 day.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ≥ 18 years of age
• Diagnosis of metastatic adenoid cystic carcinoma
• Enrolled in protocol MC200708
• Ability to tolerate a Ga68 PSMA PET/CT imaging study
• Willingness to return for a second PSMA PET/CT scan in approximately 12-20 weeks from the baseline PET/CT
• Ability to give appropriate consent or have an appropriate representative available to do so

Exclusion Criteria:

• Unable to undergo PET/CT scan
• Not a participant in MC200708
• < 18 years of age
• Persons who are pregnant or nursing
• Persons unable to consent to the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Diagnostic (Ga-68 PSMA-11, PET/CT); Patients receive Ga-68 PSMA-11 IV and then undergo PET/CT 50-70 minutes after injection at baseline and approximately 12-20 weeks during investigational therapy.

Procedure: Computed Tomography; Undergo PET/CT; Other Names: CT; CAT; CAT Scan; Computed Axial Tomography; Computerized Axial Tomography; Computerized Tomography; CT Scan; tomography; Computerized axial tomography (procedure); Computerized Tomography (CT) scan; Procedure: Positron Emission Tomography; Undergo PET/CT; Other Names: Medical Imaging, Positron Emission Tomography; PET; PET Scan; Positron Emission Tomography Scan; Positron-Emission Tomography; proton magnetic resonance spectroscopic imaging; PT; Positron emission tomography (procedure); Other: Electronic Health Record Review; Ancillary studies; Drug: Ga-68 PSMA-11; Given IV; Other Names: (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC; (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC; (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC; (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC; (68Ga)Glu-urea-Lys(Ahx)-HBED-CC; 68Ga-DKFZ-PSMA-11; 68Ga-HBED-CC-PSMA; 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC; 68Ga-PSMA; 68Ga-PSMA-11; 68Ga-PSMA-HBED-CC; [68Ga] Prostate-specific Membrane Antigen 11; [68Ga]GaPSMA-11; Ga PSMA; Ga-68 labeled DKFZ-PSMA-11; Ga-68 labeled PSMA-11; Gallium Ga 68 PSMA-11; Gallium Ga 68-labeled PSMA-11; GALLIUM GA-68 GOZETOTIDE; Gallium-68 PSMA; Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC; GaPSMA; PSMA-HBED-CC GA-68; AAA 517; AAA-517; AAA517; Gallium Ga 68 Gozetotide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment response assessment (Feasibility)	Data from the prostate specific membrane antigen (PSMA) positron emission tomography (PET)/computerized tomography (CT) exams will be categorized into treatment response categories for each participant using the Response Evaluation Criteria in PSMA PET/CT (RECIP) 1.0 criteria. Tumor volume with PSMA expression on PET/CT will be quantified using MIM Software Version 7.2.7.	Up to 20 weeks
Response assessment category and percent change in tumor volume	Will be correlated to percent change in serial PSMA extracellular vesical (EV) from serum measurements from participant data obtained in the MC200708 trial protocol. For continuous measurements (like percent change), scatter plots and simple linear regression will be conducted. Associations of these continuous variables will be done via the Spearman's rank correlation coefficient. For assessment of changes, will use Wilcoxon Signed-Rank test. For any associations of categorical variables, will use the Fisher's Exact test.	Up to 20 weeks
Incidence of adverse events	Will be assessed by the number of adverse event incidents reported. Safety will be categorized using the the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	Up to 20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change of mean standardized uptake value (SUV) of index lesions	Will be correlated with percentage change in PSMA EVs.	Up to 20 weeks
Percentage change of PSMA-avid tumor volume	Will be assessed on PET correlated with percentage change in PSMA EVs.	Up to 20 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Brian J. Burkett, MD, MPH, Mayo Clinic in Rochester

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2024
• Primary Completion (Actual): August 12, 2025
• Study Completion (Actual): August 12, 2025

Study Registration Dates

• First Submitted: July 19, 2024
• First Submitted That Met QC Criteria: July 19, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Carcinoma, Adenoid Cystic; Investigative Techniques; Chemistry Techniques, Analytical; Spectrum Analysis; Magnetic Resonance Spectroscopy; gallium 68 PSMA-11; 68Ga-DKFZ-PSMA-11
• Other Study ID Numbers: 24-003306 (Other Identifier: Mayo Clinic Institutional Review Board); NCI-2024-05893 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No