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
PRIMARY OBJECTIVES:
I. To determine the feasibility and utility of Gallium Ga 68-labeled PSMA-11 (68Ga-PSMA) PET
imaging in patients with thyroid cancer.
SECONDARY OBJECTIVES:
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.
TERTIARY OBJECTIVES:
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.
OUTLINE:
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
Interventional
Primary Outcome
Number of 68Ga PSMA-11 PET-positive Lesions
Secondary Outcome
Sensitivity of Gallium-68 PSMA for the Detection of Thyroid Cancers
Condition
Thyroid Gland Carcinoma
Intervention
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.
Publications
* 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
Drug
Estimated Enrollment
12
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
it
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Robert Flavell, MD, PhD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03463889
Organization ID
172016
Secondary IDs
NCI-2018-00055
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