Metastatic Adenoid Cystic Carcinoma
Conditions
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.
Interventions
PROCEDUREComputed Tomography
Undergo PET/CT
OTHERElectronic Health Record Review
Ancillary studies
DRUGGa-68 PSMA-11
Given IV
PROCEDUREPositron Emission Tomography
Undergo PET/CT
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment response assessment (Feasibility) | 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. |
| Response assessment category and percent change in tumor volume | 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. |
| Incidence of adverse events | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage change of mean standardized uptake value (SUV) of index lesions | Up to 20 weeks | Will be correlated with percentage change in PSMA EVs. |
| Percentage change of PSMA-avid tumor volume | Up to 20 weeks | Will be assessed on PET correlated with percentage change in PSMA EVs. |
Countries
United States
Outcome results
None listed