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Trophoblast Cell-Surface Antigen 2 (Trop-2) Targeted PET/CT in Recurrent and Metastatic Thyroid Cancer and Compared With 68Ga-FAPI PET/CT

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The First Affiliated Hospital of Xiamen University, Xiamen, Fujian 361000
RECRUITING
Xiamen
Contact Information
Primary
Haojun Chen, MD, PhD
leochen0821@foxmail.com
18659285282
Backup
Hao Fu, MD, PhD
fuhaonuclear@163.com
15959230059
Time Frame
Start Date: 2026-08-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 120
Treatments
Experimental: 68Ga-MY6349 PET/CT
Each subject receives a single intravenous injection of 68Ga-MY6349 and undergoes PET/CT imaging within the specified time.
Related Therapeutic Areas
Sponsors
Leads: The First Affiliated Hospital of Xiamen University

This content was sourced from clinicaltrials.gov