In this study, we comprehensively evaluated the clinical utility of Trop2 PET/CT (68Ga-MY6349 PET/CT) imaging for detecting recurrent and metastatic thyroid cancer, and the results were compared with those of 18F-FDG PET/CT. The primary objective of this study was to evaluate the patient-based sensitivity of 68Ga-MY6349 PET/CT in detecting recurrent and metastatic thyroid cancer. The secondary objectives included its overall specificity, lesion-based diagnostic performance, comparative tumor uptake relative to 18F-FDG PET/CT, safety profile, and the impact on clinical management.
Trophoblast cell-surface antigen 2 (Trop2), a transmembrane glycoprotein, is highly expressed in most epithelial cancers but has low expression in most normal tissues. Notably, Trop2 expression is significantly elevated in thyroid cancer, representing an important molecular hallmark of thyroid cancer. Previously, we developed a Trop2-specific radiotracer for PET/CT imaging, 68Ga-MY6349, with the potential for clinical translation across various cancer types. In particular, 68Ga-MY6349 PET/CT demonstrated the highest tumor uptake in PTC across 15 cancer types, enabling visualization of more metastatic lesions than conventional 18F-FDG PET/CT. In this study, we comprehensively evaluated the clinical utility of Trop2 PET/CT imaging for detecting recurrent and metastatic thyroid cancer, and the results were compared with standard-of-care imaging (18F-FDG PET/CT). The primary objective of this study was to evaluate the patient-based sensitivity of 68Ga-MY6349 PET/CT in detecting recurrent and metastatic thyroid cancer. The secondary objectives included its overall specificity, lesion-based diagnostic performance, comparative tumor uptake relative to 18F-FDG PET/CT, safety profile, and the impact on clinical management.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
149
Each subject receives a single intravenous injection of standard-of-care imaging radiopharmaceuticals (18F-FDG) and 68Ga-MY6349, and undergoes PET/CT imaging within the specified time. For participants who were not radioiodine-refractory or who did not have MTC or ATC, DxWBS was conducted. Each participant received an intramuscular injection of rhTSH on two consecutive days, followed by the oral administration of 131I. DxWBS was performed 2 days after 131I administration
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Diagnostic performance (patient-based)
The patient-based sensitivity of 68Ga-MY6349 and standard-of-care imaging (18F-FDG PET/CT) were calculated and compared.
Time frame: 2 years
Diagnostic performance (patient-based)
Patient-based specificity of 68Ga-MY6349 PET/CT and standard-of-care imaging (18F-FDG PET/CT) were calculated and compared.
Time frame: 2 years
Diagnostic performance
Lesion-based diagnostic accuracy (sensitivity, specificity, and accuracy) of 68Ga-MY6349 and standard-of-care imaging (18F-FDG PET/CT) were calculated and compared.
Time frame: 2 years
SUVmax and TBR
Tumor uptake comparison between 68Ga-MY6349 PET/CT and standard-of-care imaging (18F-FDG PET/CT) at the individual lesion level were calculated and compared.
Time frame: 2 years
68Ga-MY6349 safety
Patients were monitored for adverse events (AEs) during and up to 24 h after radiotracer administration. Vital signs, including body temperature, heart rate, and blood pressure, were recorded pre- and post-⁶⁸Ga-MY6349 injection.
Time frame: 24 h
The impact on clinical management
Proportion of patients with change in management plan based on 68Ga-MY6349 PET/CT versus conventional imaging or 18F-FDG PET/CT, which is defiend as the proportion of patients whose clinical management strategy was modified based on 68Ga-MY6349 PET/CT findings, compared to the initial plan derived from conventional imaging or 18F-FDG PET/CT.
Time frame: 2-4 weeks
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