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Completed

NCT Number: NCT06521775

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

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Key information

Conditions

Metastatic Adenoid Cystic Carcinoma Adenocarcinoma Carcinoma Carcinoma, Adenoid Cystic Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computed Tomography

Procedure

Undergo PET/CT

Other names: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Electronic Health Record Review

Other

Ancillary studies

Ga-68 PSMA-11

Drug

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, AAA 517, AAA-517, AAA517, 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, Gallium Ga 68 Gozetotide

Positron Emission Tomography

Procedure

Undergo PET/CT

Other names: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT

Primary outcomes

  1. Treatment response assessment (Feasibility)

    Time frame: Up to 20 weeks

    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.

  2. Response assessment category and percent change in tumor volume

    Time frame: Up to 20 weeks

    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.

  3. Incidence of adverse events

    Time frame: Up to 20 weeks

    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.

Secondary outcomes

  1. Percentage change of mean standardized uptake value (SUV) of index lesions

    Time frame: Up to 20 weeks

    Will be correlated with percentage change in PSMA EVs.

  2. Percentage change of PSMA-avid tumor volume

    Time frame: Up to 20 weeks

    Will be assessed on PET correlated with percentage change in PSMA EVs.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Pilot Study Evaluating PSMA PET For Metastatic Adenoid Cystic Carcinoma

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 26, 2024
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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