Malignant renal tumor
Conditions
Interventions
Index test:68Ga-NOTA-MW70 PET/CT
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Adult patients (18 years and older), gender not limited. 2. Patients clinically diagnosed with malignant renal tumors (discovered via CT/ultrasound/MRI). 3. Patients who can provide informed consent (signed by the individual if capable of giving informed consent; signed by the participant, family member, or legal representative if incapable of giving informed consent) and who consent according to the guidelines of the Clinical Research Ethics Committee. 4. Complete blood count: White blood cell count (WBC) 4~10×10?/L; Platelet count (PLT) 100~300 ×10?/L; Hemoglobin (HB) 120~160 g/L. 5. Renal function: Serum creatinine less than or equal to the upper limit of the normal range. 6. Liver function: Bilirubin, AST (SGOT)/ALT (SGPT) less than or equal to the upper limit of the normal range. 7. Electrocardiogram: No significant abnormalities. 8. Patients of childbearing age who can use contraception.
Exclusion criteria
Exclusion criteria: 1. The candidate study participant has contraindications to PET/CT scanning. This includes, but is not limited to, uncontrolled hyperglycemia; pregnancy, lactation, or breastfeeding women; inability to receive repeated intravenous injections; potential allergies to the drug or its components (including a history of severe allergies or allergic reactions, especially to the drug being tested); 5.claustrophobia. 2. In the past year, in addition to the radiation exposure expected in this clinical study, the candidate has participated in other research protocols or clinical care that resulted in radiation exposure exceeding the effective dose of 50 mSv. 3. The candidate study participant has the following uncontrollable clinical conditions: including but not limited to systemic diseases such as coronary artery disease, heart failure, unstable angina or arrhythmia, uremia, liver failure, sudden stroke, acute myocardial infarction, and unstable diabetes. They may have a history of head injury, intracranial surgery; hypoxia, sepsis, or severe infectious diseases; mental disorders, epilepsy, and major depressive disorder or a history of such conditions; or a history of a positive HIV test. 4. The candidate study participant has significant abnormalities in laboratory tests, which are considered clinically significant or unstable. 5. Drug abuse or alcoholism for at least 3 months. 6. The candidate study participant has any clinical condition that the study principal investigator believes may cause or has the potential to cause harm with this preparation. 7. Possible allergy to any component of 68Ga-NOTA-MW70 injection. 8. Patients with a clinical diagnosis suggestive of renal pelvis tumor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Standardized Uptake Value;Tumor-to-Background Ratio; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity, specificity, accuracy, positive predictive value, and negative predictive value;Area under the receiver operating characteristic curve; | — |
Countries
China
Contacts
Public ContactYihui Guan
Huashan Hospital, Fudan University
Outcome results
None listed