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Research on the Application of 68Ga-DOTA-CCK-FS PET/CT in MTC

RecruitingNAAges any - anyAllLuo Yaping
NCT07138716 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study explores the clinical application of 68Ga-DOTA-CCK-FS PET/CT in detecting cholecystokinin-2 receptor (CCK-2R)-positive tumors, particularly medullary thyroid cancer (MTC) and other malignancies. Led by Prof. Luo Yaping (PUMCH Nuclear Medicine) and Prof. Liu Zhibo (Peking University, radiochemistry expert), the trial will enroll 30-40 patients to compare 68Ga-DOTA-CCK-FS imaging with standard PET/CT (e.g., 18F-FDG or 68Ga-DOTATATE). The novel tracer shows higher tumor uptake and retention in preclinical studies, potentially improving diagnosis and treatment guidance for aggressive, CCK-2R-expressing cancers. The study leverages PUMCH's Class IV Radioactive Drug License for advanced radiopharmaceutical development. Risks are minimal (diagnostic radiation dose only), and participants receive free imaging assessments. Results aim to refine precision diagnostics for MTC and related

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📋 Eligibility rules (as published)
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).\*
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What it tests

  • 68Ga-DOTA-CCK-FS PET/CT
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Where

1 site
Peking Union Medical College Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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