Gallium-68 Prostate Specific Membrane Antigen PET in Diagnosing Patients With Thyroid Cancer
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|ClinicalTrials.gov Identifier: NCT03463889|
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : August 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Thyroid Gland Carcinoma||Drug: Gallium Ga 68-labeled PSMA-11 Procedure: Magnetic Resonance Imaging Procedure: Positron Emission Tomography (PET)||Phase 2|
I. To determine the feasibility and utility of Gallium Ga 68-labeled PSMA-11 (68Ga-PSMA) PET imaging in patients with thyroid cancer.
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.
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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Gallium-68 Prostate Specific Membrane Antigen (68Ga-PSMA) PET for Imaging of Thyroid Cancer: A Feasibility Study|
|Actual Study Start Date :||March 19, 2018|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: 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.
Drug: Gallium Ga 68-labeled PSMA-11
Procedure: Magnetic Resonance Imaging
Undergo MRI in combination with PET
Procedure: Positron Emission Tomography (PET)
Undergo PET in combination with MRI
- Number of Gallium-68 prostate specific membrane antigen (68Ga PSMA-11) positron emission tomography (PET) - positive lesions [ Time Frame: Up to 24 months ]Will be descriptively reported for each patient and correlated with the lesions observed in standard magnetic resonance imaging (MRI).
- Number of overall detected thyroid cancer lesions [ Time Frame: Up to 24 months ]Will be descriptively reported for each patient and correlated with the lesions observed in standard MRI.
- Standardized uptake value maximum (SUVmax) [ Time Frame: Up to 24 months ]Mean SUVmax across all visualized lesions per patient will be descriptively reported.
- Comparison of SUVmax-average (avg) by group [ Time Frame: Up to 24 months ]The patient cohort will be dichotomized by thyroglobulin level. The mean SUVmax-avg between dichotomized subgroups will be compared using the non-parametric Mann-Whitney U test and across all patients in the study cohort will be descriptively reported.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03463889
|Contact: Madeleine Welshemail@example.com|
|United States, California|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94115|
|Contact: Madeleine Welsh 877-827-3222 firstname.lastname@example.org|
|Principal Investigator: Robert Favell, MD, PhD|
|Principal Investigator:||Robert Flavell, MD, PhD||University of California, San Francisco|