NCT06465017

ImmunoPET Targeting Trophoblast Cell-Surface Antigen 2 (Trop-2) in Thyroid Cancer

ImmunoPET Targeting Trophoblast Cell-Surface Antigen 2 (Trop-2) in Thyroid Cancer and Compared With 18F-FDG and 68Ga-FAPI

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: The First Affiliated Hospital of Xiamen University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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 and 68Ga-FAPI. 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 and 68Ga-FAPI, safety profile, and the impact on clinical management.

Detailed description

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 and 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 18F-FDG and 68Ga-FAPI PET/CT, safety profile, and the impact on clinical management.

Conditions

• Tumor
• Solid Tumor
• Thyroid Cancer
• Positron-Emission Tomography

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	standard-of-care imaging (18F-FDG and 68Ga-FAPI PET/CT), 68Ga-MY6349 PET/CT	Each subject receives a single intravenous injection of standard-of-care imaging radiopharmaceuticals (18F-FDG and 68Ga-FAPI) 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

Timeline

• Start date: 2024-01-04
• Primary completion: 2024-12-31
• Completion: 2026-01-31
• First posted: 2024-06-18
• Last updated: 2026-03-27

Locations

1 site across 1 country: China