Status:
RECRUITING
Research on the Application of 68Ga-DOTA-CCK-FS PET/CT in MTC
Lead Sponsor:
Luo Yaping
Collaborating Sponsors:
Peking Union Medical College Hospital
Conditions:
Medullary Thyroid Carcinoma
Eligibility:
All Genders
Phase:
NA
Brief Summary
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 malignan...
Detailed Description
This clinical study investigates the diagnostic potential of 68Ga-DOTA-CCK-FS PET/CT, a novel radiopharmaceutical targeting the cholecystokinin-2 receptor (CCK-2R), in patients with medullary thyroid ...
Eligibility Criteria
Inclusion
- Age not limited (male or female).
- 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).
- Performance Status: Life expectancy ≥12 weeks.
- Contraception: Willingness to use effective birth control (if applicable).
- Consent: Signed informed consent and compliance with follow-up.
Exclusion
- 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).
- \*Note: CCK-2R positivity may be confirmed via prior immunohistochemistry (if available) or inferred from tumor type (e.g., MTC).\*
Key Trial Info
Start Date :
May 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07138716
Start Date
May 10 2025
End Date
December 1 2028
Last Update
August 24 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730