Trophoblast Cell-Surface Antigen 2 (Trop-2) Targeted PET/CT in Recurrent and Metastatic Thyroid Cancer

Sponsor
The First Affiliated Hospital of Xiamen University
Study ID
NCT07753499
Status
Recruiting
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Conditions

  • Solid Tumor
  • Thyroid Cancer
  • Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Compared the diagnostic performance of 68Ga-MY6349 PET/CT with 68Ga-FAPI PET/CT — DIAGNOSTIC_TEST
    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

Study Details

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.

Key Dates

First listed
Aug 7, 2026
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 68Ga-MY6349 PET/CT
    Each subject receives a single intravenous injection of 68Ga-MY6349 and undergoes PET/CT imaging within the specified time.

Primary Outcome Measure

Diagnostic performance (patient-based) [ Time Frame: 2 years ]

Central Contacts

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