68Ga-DOTA-CCK-FS PET/CT imaging for medullary 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 tests a novel radiotracer, 68Ga-DOTA-CCK-FS, that targets the cholecystokinin-2 receptor (CCK-2R) in patients with medullary thyroid carcinoma (MTC) or other CCK-2R–expressing tumors. About 30–40 participants with confirmed or suspected MTC (or other CCK-2R–positive malignancies) will receive the investigational PET/CT and a standard PET/CT (18F-FDG or 68Ga-DOTATATE) within two weeks for direct comparison. Imaging outcomes include visual reads and quantitative measures such as SUV to compare sensitivity, specificity, and tumor uptake/retention. The tracer is produced under PUMCH’s Class IV radioactive drug license, preclinical data show higher tumor uptake, and safety monitoring focuses on diagnostic radiation exposure and routine adverse-event surveillance.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age not limited (male or female).
2. Diagnosis:Confirmed or suspected medullary thyroid carcinoma (MTC) based on:

   Fine-needle aspiration (FNA) cytology/histopathology, or Elevated serum calcitonin/CEA with thyroid nodule(s), or Clinical/hereditary suspicion (e.g., MEN2 syndrome), or Other histologically confirmed CCK-2R-positive tumors (e.g., neuroendocrine tumors, gastric/ovarian cancers).
3. Performance Status: Life expectancy ≥12 weeks.
4. Contraception: Willingness to use effective birth control (if applicable).
5. Consent: Signed informed consent and compliance with follow-up.

Exclusion Criteria:

1. Severe hepatic/renal dysfunction (e.g., ALT/AST \>3×ULN, Cr \>2.0 mg/dL).
2. Pregnancy/lactation or planned pregnancy during the study.
3. Inability to lie still for PET/CT (e.g., severe claustrophobia).
4. Concurrent conditions compromising study safety (investigator's judgment).

\*Note: CCK-2R positivity may be confirmed via prior immunohistochemistry (if available) or inferred from tumor type (e.g., MTC).\*

Where it's running

• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Yaping LUO — Peking Union Medical College Hospital
• Study coordinator: Yaping Luo, MD
• Email: luoyaping@live.com
• Phone: 86-010-69154716

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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.