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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 below

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I have been diagnosed with metastatic adenoid cystic carcinoma.

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I can undergo a Ga68 PSMA PET/CT scan.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 20 weeks for reporting.

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

~2740

Positron Emission Tomography

2011

Completed Phase 2

~2200