An interventional study of Compared the diagnostic performance of 68Ga-MY6349 PET/CT with 68Ga-FAPI PET/CT in Tumor, Solid Tumor and Thyroid Cancer, sponsored by The First Affiliated Hospital of Xiamen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by The First Affiliated Hospital of Xiamen University · Not applicable, Interventional, and Diagnostic
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.
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 evaluated the diagnostic performance of 68Ga-MY6349 PET/CT in recurrent and metastatic thyroid cancer and compared it with 18F-FDG PET/CT. The results demonstrated that 68Ga-MY6349 PET/CT was superior to 18F-FDG PET/CT for lesion detection, particularly in patients with PTC and TENIS. In addition, fibroblast activation protein is highly expressed in cancer-associated fibroblasts in thyroid cancer. 68Ga-labeled FAP inhibitor (FAPI) has demonstrated favorable in vivo pharmacokinetics and higher diagnostic accuracy than 18F-FDG in various types of cancers, including thyroid cancer.
In this study, we comprehensively evaluated the clinical utility of 68Ga-MY6349 PET/CT imaging for detecting recurrent and metastatic thyroid cancer, and the results were compared with 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.
785 studies on the registry are indexed under Thyroid Neoplasms; 204 are open to participants now.
This study's planned enrollment of 120 is above the median of 53 across 520 interventional studies indexed under Thyroid Neoplasms.
Browse Thyroid Neoplasms studies →The First Affiliated Hospital of Xiamen University is the lead sponsor of 119 studies on the registry; 80 are open to participants now.
Compared within Thyroid Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Each subject receives a single intravenous injection of 68Ga-MY6349 and undergoes PET/CT imaging within the specified time.
Diagnostic Test: Compared the diagnostic performance of 68Ga-MY6349 PET/CT with 68Ga-FAPI PET/CT
Each 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.
Time frame: 2 years
Diagnostic performance (patient-based)
Patient-based specificity of 68Ga-MY6349 PET/CT and 68Ga-FAPI PET/CT) were calculated and compared.
Time frame: 2 years
Diagnostic performance
Lesion-based diagnostic accuracy (sensitivity, specificity, and accuracy) of 68Ga-MY6349 and 68Ga-FAPI PET/CT were calculated and compared.
Time frame: 2 years
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.
Time frame: 2 years
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.
Time frame: 2-4 weeks
Start is estimated for Aug 2026; primary completion for Dec 2026, 4 months later.
Of 126 non-industry interventional studies with no phase under Thyroid Neoplasms, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 78. This study's planned 4 months is below that.
Counting every sponsor, half of 127 studies reached it within 46 months; a quarter within 14 and three quarters within 78.
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The First Affiliated Hospital of Xiamen University →