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 68Ga-FAPI 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 68Ga-FAPI PET/CT, and the impact on clinical management.
Adult patients (aged 18 years or older);
Patients with a history of previously treated thyroid cancer, including DTC and HGFCTC following thyroidectomy with or without 131I therapy, MTC after thyroidectomy, or ATC; either (1) evidence of structural or suspicious lesions on standard of care imaging or (2) biochemical evidence of disease in the absence of structural findings, defined as elevated thyrotropin suppressed thyroglobulin (Tgon ≥1 ng/mL after 131I ablation or ≥5 ng/mL without ablation) with negative anti thyroglobulin antibodies (<20 IU/mL) for DTC and HGFCTC or elevated calcitonin (>10 pg/mL) for MTC;
Patients who had scheduled both 68Ga-MY6349 and 68Ga-FAPI PET/CT scans;
Patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
Pregnant or lactating patients;
Patients with a second primary tumor;
The inability or unwillingness of the research participant, parent, or legal representative to provide written informed consent.
Single group
Compared the diagnostic performance of 68Ga-MY6349 PET/CT with 68Ga-FAPI PET/CT
Diagnostic testEach subject receives a single intravenous injection of 68Ga-MY6349 and 68Ga-FAPI 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
Diagnostic performance (patient-based)
The patient-based sensitivity of 68Ga-MY6349 and 68Ga-FAPI PET/CT) were calculated and compared.
Diagnostic performance (patient-based)
Patient-based specificity of 68Ga-MY6349 PET/CT and 68Ga-FAPI PET/CT) were calculated and compared.
Diagnostic performance
Lesion-based diagnostic accuracy (sensitivity, specificity, and accuracy) of 68Ga-MY6349 and 68Ga-FAPI PET/CT were calculated and compared.
SUVmax and TBR
Tumor uptake comparison between 68Ga-MY6349 PET/CT and 68Ga-FAPI PET/CT at the individual lesion level were calculated and compared.
The impact on clinical management
Proportion of patients with change in management plan based on 68Ga-MY6349 PET/CT versus conventional imaging or 68Ga-FAPI PET/CT, which is defined 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 68Ga-FAPI PET/CT.
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