Clinical trial NCT03463889: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Thyroid Gland Carcinoma
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2018-03-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Number of 68Ga PSMA-11 PET-positive Lesions
timeFrame: Up to 24 months
measure: Number of Overall Detected Thyroid Cancer Lesions
timeFrame: Up to 24 months
measure: Mean Standardized Uptake Value Maximum of Gallium-68 PSMA (SUVmax)
timeFrame: Up to 6 months
Secondary outcomes:
measure: Sensitivity of Gallium-68 PSMA for the Detection of Thyroid Cancers
timeFrame: Up to 24 months
measure: Specificity of Gallium-68 PSMA for the Detection of Thyroid Cancers
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Robert Flavell, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: