ImmunoPET Targeting Trophoblast Cell-Surface Antigen 2 (Trop-2) in Thyroid Cancer
NCT06465017 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 149
Last updated 2026-04-20
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. 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.
Conditions
- Tumor
- Solid Tumor
- Thyroid Cancer
- Positron-Emission Tomography
Interventions
- DIAGNOSTIC_TEST
-
standard-of-care imaging (18F-FDG PET/CT), 68Ga-MY6349 PET/CT
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
Sponsors & Collaborators
-
The First Affiliated Hospital of Xiamen University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-15
- Primary Completion
- 2024-12-31
- Completion
- 2026-01-31
Countries
- China
Study Locations
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