What is 68Ga-C1 studying for clear cell renal cell carcinoma?

68Ga-C1 is being studied as a new imaging agent to better detect clear cell renal cell carcinoma using PET/CT scans. The research compares 68Ga-C1 to the standard 18F-FDG PET/CT to see which provides clearer or more accurate tumor images. This study is sponsored by Peking University First Hospital to improve diagnosis methods for this cancer type.

Who may be eligible for this clear cell renal cell carcinoma clinical trial?

Adults aged 18 years or older with confirmed or suspected clear cell renal cell carcinoma may be eligible. Both men and women can participate. Important factors include expected survival of at least six months and no recent cancer treatments in the past month. Please review eligibility criteria for more details.

Is there any cost to participate in this clear cell renal cell carcinoma clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel or other expenses may vary and are not guaranteed to be covered. Participants should plan for their own travel and accommodation costs.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

Healthy Volunteers

ID06519760

Study of 68Ga-C1 PETCT Imaging Compared to 18F-FDG PETCT for Diagnosing Clear Cell Renal Cell Carcinoma in Adults

Led by Peking University First Hospital · Updated on 2024-11-07

200

Participants Needed

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to assess the diagnostic value of a new PETCT 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 PETCT 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 mCikg, followed by PET imaging. They will also undergo a whole-body 18F-FDG PETCT scan within one week. This approach allows direct comparison of the two imaging techniques in the same patients. During the study, participants will have PETCT 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

Age: 18Years +

All Genders

Healthy Volunteers

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

Research Team

Kan Gong

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