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

NCT ID: NCT06521775

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-12

Study Completion Date

2025-08-12

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Metastatic Adenoid Cystic Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Computed Tomography

Intervention Type PROCEDURE

Undergo PET/CT

Electronic Health Record Review

Intervention Type OTHER

Ancillary studies

Ga-68 PSMA-11

Intervention Type DRUG

Given IV

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET/CT

Interventions

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Computed Tomography

Undergo PET/CT

Intervention Type PROCEDURE

Electronic Health Record Review

Ancillary studies

Intervention Type OTHER

Ga-68 PSMA-11

Given IV

Intervention Type DRUG

Positron Emission Tomography

Undergo PET/CT

Intervention Type PROCEDURE

Other Intervention Names

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CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized axial tomography (procedure) Computerized Tomography Computerized Tomography (CT) scan CT CT Scan tomography (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 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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian J. Burkett, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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NCI-2024-05893

Identifier Type: REGISTRY

Identifier Source: secondary_id

24-003306

Identifier Type: OTHER

Identifier Source: secondary_id

24-003306

Identifier Type: -

Identifier Source: org_study_id

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