Actively Recruiting
Research on the Application of 68Ga-DOTA-CCK-FS PET/CT in MTC
Led by Luo Yaping · Updated on 2025-08-24
30
Participants Needed
1
Research Sites
185 weeks
Total Duration
On this page
Sponsors
L
Luo Yaping
Lead Sponsor
P
Peking Union Medical College Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Research on the Application of 68Ga-DOTA-CCK-FS PET/CT in MTC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Any age, male or female
- Confirmed or suspected medullary thyroid carcinoma based on fine-needle aspiration cytology, histopathology, elevated serum calcitonin/CEA with thyroid nodules, or clinical/hereditary suspicion such as MEN2 syndrome
- Other histologically confirmed tumors positive for CCK-2R, including neuroendocrine, gastric, or ovarian cancers
- Life expectancy of at least 12 weeks
- Willingness to use effective birth control if applicable
- Signed informed consent and agreement to comply with follow-up
You will not qualify if you...
- Severe liver or kidney dysfunction (e.g., ALT/AST greater than 3 times upper limit of normal, creatinine above 2.0 mg/dL)
- Pregnancy, breastfeeding, or planned pregnancy during the study
- Unable to lie still for PET/CT scanning, such as severe claustrophobia
- Any other medical conditions that may compromise safety as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
Y
Yaping Luo, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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