RecruitingNot ApplicableNCT07138716

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)

Sponsor

Luo Yaping

Enrollment

30 participants

Start Date

May 10, 2025

Study Type

INTERVENTIONAL

Conditions

Medullary Thyroid Carcinoma

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

Plain Language Summary

Simplified for easier understanding

This study is using a specialized PET/CT scan with a tracer called 68Ga-DOTA-CCK-FS to image medullary thyroid cancer — a rare type of thyroid cancer — with the goal of detecting where the cancer has spread and whether this imaging approach is more accurate than current methods. **You may be eligible if...** - You have been diagnosed with medullary thyroid cancer (MTC) - Your doctor suspects the cancer may have returned or spread and standard imaging has been inconclusive - You are able to undergo a PET/CT scan **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have kidney problems that could affect how the tracer is processed - You have significant allergies to the scan tracer components - You are unable to hold still during the imaging procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TEST68Ga-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

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NCT07138716

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