NCT06521775

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2024

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 26, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

August 12, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2025

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

July 19, 2024

Last Update Submit

September 11, 2025

Conditions

Metastatic Adenoid Cystic Carcinoma

Outcome Measures

Primary Outcomes (3)

  • Treatment response assessment (Feasibility)

    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.

    Up to 20 weeks

  • Response assessment category and percent change in tumor volume

    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.

    Up to 20 weeks

  • Incidence of adverse events

    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.

    Up to 20 weeks

Secondary Outcomes (2)

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

    Up to 20 weeks

  • Percentage change of PSMA-avid tumor volume

    Up to 20 weeks

Study Arms (1)

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

EXPERIMENTAL

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.

Procedure: Computed TomographyOther: Electronic Health Record ReviewDrug: Ga-68 PSMA-11Procedure: Positron Emission Tomography

Interventions

Computed TomographyPROCEDURE

Undergo PET/CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography
Diagnostic (Ga-68 PSMA-11, PET/CT)
Electronic Health Record ReviewOTHER

Ancillary studies

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

Given IV

Also known as: (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
Diagnostic (Ga-68 PSMA-11, PET/CT)
Positron Emission TomographyPROCEDURE

Undergo PET/CT

Also known as: 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
Diagnostic (Ga-68 PSMA-11, PET/CT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Adenoid Cystic

Interventions

gallium 68 PSMA-1168Ga-DKFZ-PSMA-11Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Brian J. Burkett, MD, MPH

    Mayo Clinic in Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2024

First Posted

July 26, 2024

Study Start

August 12, 2024

Primary Completion

August 12, 2025

Study Completion

August 12, 2025

Last Updated

September 12, 2025

Record last verified: 2025-09

Locations

US(1)