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NCT07914764
68Ga-labeled Cholecystokinin Receptor (CCK2R) Targeted Molecular Probes in Early Tumor Diagnosis
Conditions: Medullary Thyroid Carcinoma, Small Cell Lung Cancer ( SCLC ), Gastric Adenocarcinoma
Sex: All
Ages: 18 Years – 75 Years
Enrollment: 20
Sponsor: Nanjing First Hospital, Nanjing Medical University
Location: Nanjing First Hospital Nanjing Jiangsu
Summary
Evaluate the safety of the novel radioactive nuclide-labeled cholecystokinin receptor (CCK2R) targeted molecular probe, 68Ga-YQ-CC05, in clinical application, and verify its effectiveness in tumor diagnosis.
Eligibility Criteria
Inclusion Criteria:
* Volunteer to participate in the trial, with the patient or their legal guardian signing the informed consent form;
* Volunteers are not limited by gender, and the age range is from 18 to 75 years old, inclusive;
* Other imaging examination methods (CT, MRI, etc.) reveal tumor occupying lesions;
* Tumor patients who can obtain the final pathological results.
* Kidney: GFR \> 50 ml/min, ERPF \> 280 ml/min, platelet count (PLT) \> 75,000/μL, white blood cell (WBC) \> 3,000/μL, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 3 times the normal value.
Exclusion Criteria:
* Individuals with a history of allergy to similar drugs (drugs with similar chemical or biological components to CCK2R), allergic constitution, or current allergic diseases;
* Those who are currently participating in other clinical drug studies, or have previously participated in any clinical drug studies (excluding vitamins and minerals);
* Other uncontrollable clinical issues (such as HIV, hepatitis C virus infection, active hepatitis B, or other severe chronic infections, as well as severe mental, neurological, cardiovascular, respiratory, and other systemic diseases);
* Red blood cells (RBC) count less than 4×10\^12, white blood cells (WBC) count less than 3×10\^9, hemoglobin level less than 110g/L, and platelet count (PLT) less than 75,000×10\^9;
* Obvious abnormalities in liver and kidney function, with GFR less than 50 ml/min;
* Tumor burden greater than 50%, or significant spinal cord compression;
* Expected survival duration less than half a year; chemotherapy within 6 months;
* Having severe acute concomitant diseases or severe treatment-resistant mental disorders;
* Pregnant and lactating women (where pregnancy is defined as a positive urine pregnancy test result);
* Patients who are physically unfit for radiological examinations;
* Other situations where the researcher deems it inappropriate for the participant to participate in the trial.
Source: ClinicalTrials.gov (NCT07914764). StuddyBuddy aggregates publicly available trial information.