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)

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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 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
Participation Requirements
Sex: All
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
Yaping Luo, MD
luoyaping@live.com
86-010-69154716
Time Frame
Start Date: 2025-05-10
Estimated Completion Date: 2028-12-01
Participants
Target number of participants: 30
Treatments
Other: 68Ga-DOTA-CCK-FS and 68Ga-DOTA-TATE PET/CT imaging
For the patients with neuroendocrine neoplasm. Intravenous administration of 1.8-2.2 MBq/kg (0.05-0.06 mCi/kg) of each radiotracer within one week. For 68Ga-DOTA-CCK-FS, imaging begins 60±5 minutes post-injection to evaluate cholecystokinin receptor (CCK-R) expression, while 68Ga-DOTA-TATE scanning starts at 45-60 minutes post-injection for somatostatin receptor (SSTR) assessment, both using a time-of-flight PET/CT system with low-dose CT (120 kVp, 30-50 mAs) for attenuation correction followed by whole-body PET acquisition (2-3 min/bed position). Images are reconstructed using OSEM algorithms
Other: 68Ga-DOTA-CCK-FS and 18F-FDG PET/CT imaging
For the patients with non-neuroendocrine neoplasm. 68Ga-DOTA-CCK-FS PET/CT was perfomed 60±5 minutes post-injection of 1.8-2.2 MBq/kg (0.05-0.06 mCi/kg) tracer. The 18F-FDG PET/CT imaging protocol requires patients to fast for at least 6 hours and maintain blood glucose levels \<150-200 mg/dL prior to intravenous administration of 3.7-5.2 MBq/kg (0.1-0.14 mCi/kg) of 18F-FDG. After a 60±5 minute uptake period , imaging is performed on a time-of-flight PET/CT system (2-3 minutes per bed position, covering skull base to mid-thigh).
Sponsors
Leads: Luo Yaping
Collaborators: Peking Union Medical College Hospital

This content was sourced from clinicaltrials.gov

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