RECRUITINGINTERVENTIONAL

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

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)

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 diagnosed by tissue sample (biopsy-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 willing to sign a consent form and compliance with follow-up. Who Should NOT Join This Trial: 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).\* Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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).\*

Treatments Being Tested

DIAGNOSTIC_TEST

68Ga-DOTA-CCK-FS PET/CT

For 68Ga-DOTA-CCK-FS, imaging begins 60±5 minutes post-injection to evaluate cholecystokinin receptor (CCK-R) expression, 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.

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China