About this trial
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 tumors.
Eligibility criteria
Qualifiers
Age not limited (male or female).
Performance Status: Life expectancy ≥12 weeks.
Contraception: Willingness to use effective birth control (if applicable).
Consent: Signed informed consent and compliance with follow-up.
Disqualifiers
Severe hepatic/renal dysfunction (e.g., ALT/AST >3×ULN, Cr >2.0 mg/dL).
Pregnancy/lactation or planned pregnancy during the study.
Inability to lie still for PET/CT (e.g., severe claustrophobia).
Concurrent conditions compromising study safety (investigator's judgment).
Trial design
Treatments tested in this trial
- 68Ga-DOTA-CCK-FS PET/CT
Treatment groups
Sponsors and collaborators
Luo Yaping
Lead sponsor
Peking Union Medical College Hospital
Sponsor institution
Peking Union Medical College Hospital
Collaborator