Metastatic Adenoid Cystic CarcinomaPhase 2NCT06521775
An Investigational Scan (Ga-68 PSMA-11 PET/CT) for the Detection of Therapy Response in Patients With Metastatic Adenoid Cystic Carcinoma
A Phase 2 study testing Computed Tomography, Electronic Health Record Review and Ga-68 PSMA-11 in people with Metastatic Adenoid Cystic Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Adenoid Cystic Carcinoma
- What is being tested?
- Computed Tomography, Electronic Health Record Review and Ga-68 PSMA-11
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2024to 12 Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Pilot Study Evaluating PSMA PET For Metastatic Adenoid Cystic Carcinoma
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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
- Metastatic Adenoid Cystic Carcinoma
- Being tested
- Computed Tomography, Electronic Health Record Review, Ga-68 PSMA-11, Positron Emission Tomography
- Medical subject headings
- Carcinoma, Adenoid Cystic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo PET/CT
Electronic Health Record ReviewOther
Ancillary studies
Ga-68 PSMA-11Drug
Also called (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
Given IV
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET/CT
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Computed Tomography; Other: Electronic Health Record Review; Drug: Ga-68 PSMA-11; Procedure: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to 20 weeks
Secondary outcomes (2)
Percentage change of mean standardized uptake value (SUV) of index lesions
Will be correlated with percentage change in PSMA EVs.
Measured: Up to 20 weeks
Percentage change of PSMA-avid tumor volume
Will be assessed on PET correlated with percentage change in PSMA EVs.
Measured: Up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start12 Aug 2024
- Primary completion12 Aug 2025
- Study completion12 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Adenoid Cystic CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian J. Burkett, MD, MPH, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521775
- Sponsor's protocol ID
- 24-003306
- Other IDs
- NCI-2024-05893, 24-003306
- Status last verified
- Sep 2025
- First submitted
- 19 Jul 2024
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating PSMA PET For Metastatic Adenoid Cystic Carcinoma
- ClinicalTrials.gov ID
- NCT06521775
- Acronym / sponsor ID
- 24-003306
- Conditions
- Metastatic Adenoid Cystic Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- 12 Aug 2025 (actual)
- Study completion
- 12 Aug 2025 (actual)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (Ga-68 PSMA-11, PET/CT) | Experimental | Procedure: Computed Tomography, Other: Electronic Health Record Review, Drug: Ga-68 PSMA-11, Procedure: Positron Emission TomographyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo PET/CT | Procedure or surgery | Diagnostic (Ga-68 PSMA-11, PET/CT) |
| Electronic Health Record ReviewAncillary studies | Other | Diagnostic (Ga-68 PSMA-11, PET/CT) |
| Ga-68 PSMA-11Also: (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-CCGiven IV | Drug | Diagnostic (Ga-68 PSMA-11, PET/CT) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)Undergo PET/CT | Procedure or surgery | Diagnostic (Ga-68 PSMA-11, PET/CT) |
Primary outcome
Treatment response assessment (Feasibility)
Time frame: 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
Time frame: 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
Time frame: 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.
2 secondary outcomes
Percentage change of mean standardized uptake value (SUV) of index lesions
Time frame: Up to 20 weeks
Percentage change of PSMA-avid tumor volume
Time frame: Up to 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian J. Burkett, MD, MPH principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Computed Tomography, Electronic Health Record Review and Ga-68 PSMA-11 in people with Metastatic Adenoid Cystic Carcinoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment response assessment (Feasibility) (time frame: Up to 20 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.