Clinical trial NCT06521775: An Investigational Scan (Ga-68 PSMA-11 PET/CT) for the Detection of Therapy Response in Patients With Metastatic Adenoid Cystic Carcinoma
Official title: Pilot Study Evaluating PSMA PET For Metastatic Adenoid Cystic Carcinoma
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Metastatic Adenoid Cystic Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Treatment response assessment (Feasibility)
timeFrame: Up to 20 weeks
measure: Response assessment category and percent change in tumor volume
timeFrame: Up to 20 weeks
measure: Incidence of adverse events
timeFrame: Up to 20 weeks
Secondary outcomes:
measure: Percentage change of mean standardized uptake value (SUV) of index lesions
timeFrame: Up to 20 weeks
measure: Percentage change of PSMA-avid tumor volume
timeFrame: Up to 20 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Brian J. Burkett, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: