68Ga-DOTA-CCK-FS PET/CT imaging for medullary thyroid cancer

Application Study of 68Ga-DOTA-CCK-FS PET/CT in Medullary Thyroid Carcinoma (MTC) and Various Other Tumors With Positive Expression of Cholecystokinin-2 Receptor (CCK-2R)

This trial will test whether a new PET tracer, 68Ga-DOTA-CCK-FS, can better find medullary thyroid cancer and other CCK-2R–positive tumors than standard PET scans.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07138716 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with confirmed or suspected medullary thyroid carcinoma (based on pathology, elevated calcitonin/CEA, or MEN2 history) or other confirmed CCK-2R–positive tumors who can consent, tolerate PET/CT, and have life expectancy of at least 12 weeks.

Not a fit: Patients unlikely to benefit include those with non–CCK-2R-expressing tumors, severe hepatic or renal dysfunction, pregnancy or lactation, inability to undergo PET/CT, or other conditions that make participation unsafe per the investigator.

Why it matters

Potential benefit: If successful, the tracer could improve detection and localization of aggressive, CCK-2R–expressing MTC and help guide treatment decisions.

How similar studies have performed: Preclinical studies report higher tumor uptake and retention for this tracer, but clinical data are limited and the application in MTC is relatively novel.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality

• 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

Conditions Medullary Thyroid Carcinoma; MTC; CCK-2R; PET/CT