Gallium-68 Prostate Specific Membrane Antigen PET in Diagnosing Patients With Thyroid Cancer

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Brief Title

Gallium-68 Prostate Specific Membrane Antigen PET in Diagnosing Patients With Thyroid Cancer

Official Title

Gallium-68 Prostate Specific Membrane Antigen (68Ga-PSMA) PET for Imaging of Thyroid Cancer: A Feasibility Study

Brief Summary

      This pilot clinical trial studies how well Gallium-68 prostate specific membrane antigen
      positron emission tomography (PET) work in diagnosing patients with thyroid cancer.
      Diagnostic procedures, such as 68Ga-PSMA PET, may more accurately diagnose thyroid cancer and
      find out how far the disease has spread.

Detailed Description


      I. To determine the feasibility and utility of Gallium Ga 68-labeled PSMA-11 (68Ga-PSMA) PET
      imaging in patients with thyroid cancer.


      I. To assess the correlation between targeted molecular uptake of 68Ga-PSMA PET in thyroid
      cancer compared to areas identified as tumor by radioiodine uptake (in well-differentiated
      cancers) or fludeoxyglucose F-18 (18F-FDG) uptake (in poorly differentiated and/or
      radioiodine-negative cancers).

      II. To determine and compare the sensitivity and specificity of 68Ga-PSMA PET to (18F-FDG)
      PET and/or radioiodine scintigraphy.


      I. To determine if 68Ga-PSMA PET uptake is related to tumor differentiation and PSMA staining
      in tissue pathology when available.

      II. To determine the correlation between standardized uptake value maximum (SUVmax) of target
      thyroid cancer lesions on 68Ga-PSMA PET and serum thyroglobulin levels.


      Participants receive 68Ga-PSMA intravenously (IV) over 1-2 minutes and then undergo PET/MRI
      60 minutes after injection. Patients may undergo a second PET/MRI 2-6 months after completion
      of first scan.

Study Phase

Phase 2

Study Type


Primary Outcome

Number of 68Ga PSMA-11 PET-positive Lesions

Secondary Outcome

 Sensitivity of Gallium-68 PSMA for the Detection of Thyroid Cancers


Thyroid Gland Carcinoma


Gallium Ga 68-labeled PSMA-11

Study Arms / Comparison Groups

 Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI)
Description:  Participants receive 68Ga-PSMA IV over 1-2 minutes and then undergo PET/MRI 60 minutes after injection. Patients may undergo a second PET/MRI 2-6 months after completion of first scan.


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

March 19, 2018

Completion Date

October 31, 2020

Primary Completion Date

September 30, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  History of thyroid cancer

          -  Whole body 18F-FDG PET/computed tomography (CT) or I-131 scintigraphy within the past
             90 days of the scheduled 68Ga-PSMA PET demonstrating uptake

          -  Creatinine =< 3.0 mg/dL

          -  Ability to understand a written informed consent document, and the willingness to sign

        Exclusion Criteria:

          -  Patients who have had active infection within 15 days of study enrollment that may be
             considered to interfere with 68Ga-PSMA PET imaging by the study investigators

          -  Patients who are unable to have placement of intravenous line access

          -  Pregnant or breastfeeding women

          -  Patients not capable of undergoing a PET/MRI study due to weight, claustrophobia, or
             inability to lie still for the duration of the exam




18 Years - N/A

Accepts Healthy Volunteers



Robert Flavell, MD, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Secondary IDs


Responsible Party

Principal Investigator

Study Sponsor

University of California, San Francisco

Study Sponsor

Robert Flavell, MD, PhD, Principal Investigator, University of California, San Francisco

Verification Date

June 2021