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

University of California San Francisco (UCSF)

Status and phase: Terminated; Phase 2

Conditions: Thyroid Gland Carcinoma

Treatments: Drug: Gallium Ga 68-labeled PSMA-11; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography (PET)

Study type: Interventional

Funder types: Other

Identifiers

NCT03463889

NCI-2018-00055 (Registry Identifier)

172016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI)

Experimental group

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.

Treatment:

Procedure: Positron Emission Tomography (PET)

Procedure: Magnetic Resonance Imaging

Drug: Gallium Ga 68-labeled PSMA-11