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

Status: Active

Description

This phase II 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.

Eligibility Criteria

Inclusion Criteria

  • History of thyroid cancer
  • Whole body 18F-FDG PET/computed tomography (CT), I-123 or I-131 scintigraphy within the past 360 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

Locations & Contacts

California

San Francisco
UCSF Medical Center-Mount Zion
Status: Active
Contact: Thomas Hope
Phone: 415-221-4810
Email: Thomas.Hope@ucsf.edu

Trial Objectives and Outline

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.

EXPLORATORY 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:

Patients receive 68Ga-PSMA intravenously (IV) over 1-2 minutes and then undergo PET/magnetic resonance imaging (MRI) 50-80 minutes after injection. Patients may undergo a second PET/MRI 2-6 months after completion of first scan.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Diagnostic

Lead Organization

Lead Organization
UCSF Medical Center-Mount Zion

Principal Investigator
Thomas Hope

Trial IDs

Primary ID 172016
Secondary IDs NCI-2018-00055, 17-23649
Clinicaltrials.gov ID NCT03463889