Clear cell renal cell carcinoma
Conditions
Interventions
Index test:[68Ga]DPI-4452 PET/CT
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years, male or female; 2. A) Patients with imaging findings (CT/MRI/ultrasound) suggestive of renal cell carcinoma and scheduled to undergo surgical resection (partial or radical nephrectomy) or core needle biopsy within 4 weeks after the PET/CT scan may be enrolled in Cohort A; B) Patients with suspected or confirmed locally advanced or metastatic clear cell renal cell carcinoma who agree to undergo two PET/CT scans ([68Ga]-DPI-4452 and ¹8F-FDG) prior to treatment, and for those receiving combined targeted therapy and immunotherapy, a follow-up [68Ga]-DPI-4452 PET/CT scan after the fourth cycle of systemic therapy; 3. Subjects voluntarily participate in this study and sign an ethics committee-approved informed consent form; 4. Sexually active males and females of childbearing potential must agree to use reliable contraceptive measures from the time of signing the informed consent form until 6 months after the end of treatment; female subjects must have a negative serum pregnancy test within 7 days before enrollment; women who have undergone sterilization or are postmenopausal are considered not of childbearing potential and are eligible for enrollment; 5. Eastern Cooperative Oncology Group (ECOG) performance status <= 2; 6. Subjects are willing and able to comply with study procedures.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women; 2. Known history of severe allergic reaction to [68Ga]-DPI-4452 or ¹8F-FDG, or to any of their excipients; 3. Serum creatinine level > 2.0 mg/dL or eGFR < 30 mL/min/1.73 m² within 24 hours prior to the planned injection of [68Ga]-DPI-4452 or ¹8F-FDG, indicating severe renal impairment; 4. Any serious or unstable medical condition (e.g., uncontrolled infection, severe heart failure, etc.) that, in the investigator's judgment, may significantly affect study execution or interpretation of results; 5. Participation in another clinical trial involving use of an investigational drug within 30 days prior to tracer injection in this study; 6. Any condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy(Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall accuracy.); | — |
Secondary
| Measure | Time frame |
|---|---|
| Concordance between tracer uptake in lesions and therapeutic response;Concordance between tracer uptake in lesions and expression levels in pathology; | — |
Countries
China
Contacts
Public ContactGu Liangyou/Zhang Jinming
Chinese PLA General Hospital
Outcome results
None listed