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Clinical Trials in China / NCT07753499
Recruiting Not applicable

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

NCT07753499 · tracked via the Priya Life Science China tracker
Sponsor
The First Affiliated Hospital of Xiamen University
Phase
Not applicable
Started
2026-08-01
Last updated
2026-08-07

Condition(s) studied

TumorSolid TumorThyroid Cancer

Investigational drug(s) / intervention(s)

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

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

Study 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 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

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria: * 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. * No other anticancer therapy within four weeks prior to PET imaging. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Diagnostic performance (patient-based) — 2 years
    The patient-based sensitivity of 68Ga-MY6349 and 68Ga-FAPI PET/CT) were calculated and compared.

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Xiamen University, Xiamen, Fujian 361000 Xiamen Fujian Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07753499 on ClinicalTrials.gov ↗ ← All trials in China