About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Compared the diagnostic performance of 68Ga-MY6349 PET/CT with 68Ga-FAPI PET/CT