Trop-2 Targeted PET/CT for Recurrent and Metastatic Thyroid Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares 68Ga-MY6349 PET/CT imaging against 68Ga-FAPI PET/CT in adults with previously treated thyroid cancer and suspected recurrent or metastatic disease. Primary goal is to measure patient-based sensitivity for detecting recurrent/metastatic thyroid cancer, with secondary goals including specificity, lesion-level performance, comparative uptake, and impact on clinical management. Participants undergo both imaging modalities to allow direct comparison. The study builds on prior work suggesting Trop-2–targeted imaging may improve lesion detection in thyroid cancer. Key eligibility includes adult patients with various thyroid cancer histologies, evidence of disease, and no recent anticancer therapy within four weeks of imaging. Conducted at The First Affiliated Hospital of Xiamen University in Xiamen, China, under sponsor oversight.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of Xiamen University, Xiamen, Fujian 361000
  Xiamen, Fujian, China Recruiting

Study contacts

• Study coordinator: Haojun Chen, MD, PhD
• Email: leochen0821@foxmail.com
• Phone: 18659285282

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.