Gallium-68 Prostate Specific Membrane Antigen (68Ga-PSMA) PET for Imaging of Thyroid Cancer: A Feasibility Study
Overview
- Phase
- Phase 2
- Intervention
- Gallium Ga 68-labeled PSMA-11
- Conditions
- Thyroid Gland Carcinoma
- Sponsor
- University of California, San Francisco
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Number of 68Ga PSMA-11 PET-positive Lesions
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
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.
Investigators
Robert Flavell, MD, PhD
Asst Professor in Residence
University of California, San Francisco
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
Arms & Interventions
Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI)
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.
Intervention: Gallium Ga 68-labeled PSMA-11
Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI)
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.
Intervention: Magnetic Resonance Imaging
Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI)
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.
Intervention: Positron Emission Tomography (PET)
Outcomes
Primary Outcomes
Number of 68Ga PSMA-11 PET-positive Lesions
Time Frame: Up to 24 months
The number of 68Ga PSMA-11 PET-positive lesions detected by staging scans will be descriptively reported.
Number of Overall Detected Thyroid Cancer Lesions
Time Frame: Up to 24 months
The number of overall thyroid cancer lesions detected by standard staging scans will be descriptively reported
Mean Standardized Uptake Value Maximum of Gallium-68 PSMA (SUVmax)
Time Frame: Up to 6 months
The mean and standard deviation for SUVmax across all lesions across all patients will be reported.
Secondary Outcomes
- Sensitivity of Gallium-68 PSMA for the Detection of Thyroid Cancers(Up to 24 months)
- Specificity of Gallium-68 PSMA for the Detection of Thyroid Cancers(Up to 24 months)