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

Phase 2

Terminated

• Conditions: Thyroid Gland Carcinoma
• Interventions: Drug: Gallium Ga 68-labeled PSMA-11; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography (PET)

• Registration Number: NCT03463889
• Lead Sponsor: University of California, San Francisco

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 Timeline

• Study First Submitted: 2018-02-09
• Study First Submitted QC: 2018-03-06
• Study First Posted: 2018-03-13
• Study Start: 2018-03-19
• Primary Completion: 2020-09-30
• Study Completion: 2020-10-31
• Results First Submitted: 2021-05-18
• Status Verified: 2021-06
• Results First Submitted QC: 2021-06-25
• Last Update Submitted: 2021-06-25
• Results First Posted: 2021-06-29
• Last Update Posted: 2021-06-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI)	Gallium Ga 68-labeled PSMA-11	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.
Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI)	Magnetic Resonance Imaging	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.
Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI)	Positron Emission Tomography (PET)	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.

Primary Outcome Measures

Name	Time	Method
Number of 68Ga PSMA-11 PET-positive Lesions	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	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)	Up to 6 months	The mean and standard deviation for SUVmax across all lesions across all patients will be reported.

Secondary Outcome Measures

Name	Time	Method
Sensitivity of Gallium-68 PSMA for the Detection of Thyroid Cancers	Up to 24 months	For each lesion detected on 18F-FDG PET or radioiodine scintigraphy (131I), the presence or absence of 68Ga-PSMA-11 uptake will be reviewed and tabulated. Presence on either 131I and 18F-FDG will be considered true positive disease. If additional lesions are detected on 68Ga-PSMA-11 as compared to 18F-FDG or 131I, the lesions will be characterized as either true or false positives in comparison to the appearance of the lesion on conventional imaging (thyroid ultrasound, CT and MRI). The gold standard for an individual lesion will be FDG or 131I, if the individual lesion is positive on either imaging study. If the lesions are not seen on either FDG or 131I, then consensus reading of conventional imaging will be performed to determine true and false positives lesions. Point estimate of the true positive rate will be calculated.
Specificity of Gallium-68 PSMA for the Detection of Thyroid Cancers	Up to 24 months	Specificity is the agents ability to exclude the disease when the disease is absent. For each lesion detected on 18F-FDG PET or radioiodine scintigraphy (131I), the presence or absence of 68Ga-PSMA-11 uptake will be reviewed and tabulated. Presence on either 131I and 18F-FDG will be considered true positive disease. If additional lesions are detected on 68Ga-PSMA-11 as compared to 18F-FDG or 131I, the lesions will be characterized as either true or false positives in comparison to the appearance of the lesion on conventional imaging (thyroid ultrasound, CT and MRI). The gold standard for an individual lesion will be FDG or 131I, if the individual lesion is positive on either imaging study. If the lesions are not seen on either FDG or 131I, then consensus reading of conventional imaging will be performed to determine true and false positives lesions. Point estimate of the true negative rate will be reported.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States