Research on the Application of 68Ga-DOTA-CCK-FS PET/CT in MTC
ConditionMedullary Thyroid Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorLuo Yaping
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age not limited (male or female).
Performance Status: Life expectancy ≥12 weeks.
Contraception: Willingness to use effective birth control (if applicable).
Consent: Signed informed consent and compliance with follow-up.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
68Ga-DOTA-CCK-FS PET/CT
Diagnostic testFor 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: 68Ga-DOTA-CCK-FS and 68Ga-DOTA-TATE PET/CT imagingOther 1 intervention
Group B: 68Ga-DOTA-CCK-FS and 18F-FDG PET/CT imagingOther 1 intervention
Trial outcomes
Primary outcomes
1
diagnostic performance
Diagnostic performance of 68Ga-DOTA-CCK-FS PET/CT in detecting CCK-2R-positive tumors, as measured by sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy using histopathology or clinical follow-up as the reference standard.
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Comparative efficacy
Comparative efficacy of 68Ga-DOTA-CCK-FS PET/CT versus standard imaging (18F-FDG PET/CT for non-neuroendocrine tumors or 68Ga-DOTATATE PET/CT for neuroendocrine tumors) in: Tumor detection rate (number and location of lesions) Target-to-background ratio (TBR) based on SUVmax (tumor vs. liver/blood pool/muscle)
Time frame
through study completion, an average of 1 year2
Correlation
Correlation between 68Ga-DOTA-CCK-FS uptake (SUVmax/SUVpeak) and Serum tumor markers (e.g., calcitonin, CEA for MTC); Tumor differentiation status (if histopathology is available)
Time frame
through study completion, an average of 1 year3
Safety profile
Safety profile of 68Ga-DOTA-CCK-FS, assessed by Incidence of adverse events (AEs) related to tracer administration and Radiation dosimetry estimates
Time frame
through study completion, an average of 1 yearOther outcomes
1
Exploratory Outcomes
Potential utility of 68Ga-DOTA-CCK-FS PET/CT for: Staging/restaging of MTC and other CCK-2R-positive tumors Predicting eligibility for future peptide receptor radionuclide therapy (PRRT) Inter-reader agreement in image interpretation (kappa statistics)
Time frame
through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Luo Yaping
Lead sponsor
Peking Union Medical College Hospital
Sponsor institution
Peking Union Medical College Hospital
Collaborator
Source ClinicalTrials.gov