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

Mayo Clinic

Status and phase: Completed; Phase 2

Conditions: Metastatic Adenoid Cystic Carcinoma

Treatments: Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Other: Electronic Health Record Review; Drug: Ga-68 PSMA-11

Study type: Interventional

Funder types: Other

Identifiers

NCT06521775

NCI-2024-05893 (Registry Identifier)

24-003306 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Diagnostic (Ga-68 PSMA-11, PET/CT)

Experimental group

Description:

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.

Treatment:

Drug: Ga-68 PSMA-11

Procedure: Positron Emission Tomography

Other: Electronic Health Record Review

Procedure: Computed Tomography