Actively Recruiting
Evaluation of Diagnostic Value of 68Ga-C1 PET/CT Imaging in Clear Cell Renal Cell Carcinoma
Led by Peking University First Hospital · Updated on 2024-11-07
200
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to assess the diagnostic value of a new PET/CT imaging probe called 68Ga-C1, which specifically targets the CAIX protein found in about 95% of clear cell renal cell carcinomas. The study will also investigate the safety, tolerability, and radiation exposure from 68Ga-C1. Researchers will compare this new imaging method with the standard 18F-FDG PET/CT scan in Chinese patients who have unclear kidney masses or confirmed clear cell renal cell carcinoma. Participants with suspected or confirmed clear cell renal cell carcinoma will receive an intravenous injection of 68Ga-C1 at a dose of 0.05-0.10 mCi/kg, followed by PET imaging. They will also undergo a whole-body 18F-FDG PET/CT scan within one week. This approach allows direct comparison of the two imaging techniques in the same patients. During the study, participants will have PET/CT scans with both imaging agents to evaluate tumor detection and characteristics. Researchers will measure diagnostic accuracy, radiation dosimetry, and quantitative uptake of 68Ga-C1 over one year. Correlation with tumor pathology will also be assessed. The study will monitor safety and tolerability throughout, with the overall participation lasting at least one year.
CONDITIONS
Brief Title
68Ga-C1 PET/ CT Imaging in Clear Cell Renal Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent
- Age 18 years or older
- Patients with confirmed or suspected clear cell renal cell carcinoma
- Expected survival of at least 6 months
You will not qualify if you...
- Renal mass known to be metastasis from another primary tumor
- Other malignancies requiring treatment
- Received chemotherapy, radiotherapy, or immunotherapy within 4 weeks
- Renal insufficiency with glomerular filtration rate of 60 mL/min/1.73 m² or less
- Pregnant or breastfeeding women, or planning pregnancy within 6 months
- Uncontrolled psychiatric disorders
- Vulnerable populations or serious non-malignant diseases such as infectious, autoimmune, or metabolic diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 1 week
Participants receive an intravenous injection of 68Ga-C1 followed by PET/CT imaging and a whole-body 18F-FDG PET/CT scan within one week to evaluate clear cell renal cell carcinoma.
2 imaging visits (in-person)
Duration - Up to 1 year
Participants are monitored for up to 1 year to assess diagnostic efficacy, dosimetry, and correlation with pathological expression.
Follow-up visits as needed
Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
Research Team
K
Kan Gong
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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