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Ga-68 PSMA-11 PET/CT Scan for Cancer
Phase 2
Waitlist Available
Led By Brian J. Burkett, M.D., M.P.H.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of metastatic adenoid cystic carcinoma
Ability to tolerate a Ga68 PSMA PET/CT imaging study
Must not have
< 18 years of age
Persons unable to consent to the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 20 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether a special imaging technique called gallium-68 prostate specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT) can help detect
Who is the study for?
This trial is for patients with adenoid cystic carcinoma, a type of salivary gland cancer that has spread to other body parts. The eligibility criteria are not fully listed but typically include factors like the stage of cancer, prior treatments received, and overall health status.
What is being tested?
The trial is testing if a new scan using Ga-68 PSMA-11 PET/CT can effectively detect how well treatment is working in patients with metastatic adenoid cystic carcinoma. It combines radioactive imaging and x-ray technology to create detailed images of the body's response to therapy.
What are the potential side effects?
Since this trial focuses on diagnostic imaging rather than drug treatment, side effects may be minimal but could include discomfort from injection of the tracer, allergic reactions to it, or exposure to radiation during the scans.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with metastatic adenoid cystic carcinoma.
Select...
I can undergo a Ga68 PSMA PET/CT scan.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am under 18 years old.
Select...
I am unable to give consent for the study on my own.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 20 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 20 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events
Response assessment category and percent change in tumor volume
Treatment response assessment (Feasibility)
Secondary study objectives
Percentage change of PSMA-avid tumor volume
Percentage change of mean standardized uptake value (SUV) of index lesions
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Diagnostic (Ga-68 PSMA-11, PET/CT)Experimental Treatment4 Interventions
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2790
Positron Emission Tomography
2011
Completed Phase 2
~2200
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,362 Previous Clinical Trials
3,066,001 Total Patients Enrolled
Brian J. Burkett, M.D., M.P.H.Principal InvestigatorMayo Clinic in Rochester
1 Previous Clinical Trials
25 Total Patients Enrolled
Brian J. Burkett, MD, MPHPrincipal InvestigatorMayo Clinic in Rochester
1 Previous Clinical Trials
25 Total Patients Enrolled