68Ga-C1 PET/ CT Imaging in Clear Cell Renal Cell Carcinoma
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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 68Ga-C1.
- Who it may be relevant to
- Registry conditions: Carbonic Anhydrase IX, PET-CT, Clear Cell Renal Cell Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Diagnostic Value of 68Ga-C1 PET/ CT Imaging in Clear Cell Renal Cell Carcinoma
Overview
The goal of this clinical trial is to evaluate the diagnostic value of CAIX protein specific probe 68Ga-C1 in PET/CT imaging in clear cell renal cell carcinoma patients. It will also learn about the safety, tolerability and radiation dosimetry of 68Ga-C1. Researchers will compare the diagnostic value of 68Ga-C1 PET/CT and 18F-FDG PET/CT in Chinese patients with indeterminate renal masses or confirmed clear cell renal cell carcinoma.
Detailed description
Carbonic anhydrase IX (CAIX) is a transmembrane protein which is highly expressed in approximately 95% of clear cell renal cell carcinomas, and it is closely related to tumor progression, patients prognosis and treatment response. Here, we developed a CAIX specific small molecule probe 68Ga-C1, which has shown a good diagnostic accuracy in PET/CT imaging in our preclinical mouse model of clear cell renal cell carcinoma. This enables high-contrast imaging of clear cell renal carcinoma, providing a new imaging method for the precise diagnosis of clear cell renal carcinoma. In this clinical trail, we will compare the diagnostic value of 68Ga-C1 PET/CT and 18F-FDG PET/CT in Chinese patients with indeterminate renal masses or confirmed clear cell renal cell carcinoma.
Interventions
- Drug 68Ga-C1
68Ga-C1 is injected intravenously with a dose of 0.05-0.10 mCi/kg
Primary outcome measures
- The diagnostic efficacy of 68Ga-C1 PET/CT in the evaluation of clear cell renal cell carcinoma [Time frame: 1 year]
- The diagnostic efficacy of 68Ga-C1 PET/CT in the evaluation of malignant tumors [Time frame: 1 year]
Secondary outcome measures (3)
- The dosimetry of 68Ga-C1 [Time frame: 1 year]
- Quantitative evaluation of 68Ga-C1 [Time frame: 1 year]
- Correlation with pathological expression [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- Signed written informed consent；
- Age ≥18；
- Patients with confirmed or suspected clear cell renal cell carcinoma;
- Expected survival ≥6 months.
Exclusion criteria
- Renal mass is known to be a metastasis of another primary tumor;
- Have other malignancies that require treatment;
- Have received chemotherapy, radiotherapy, or immunotherapy within 4 weeks;
- Renal insufficiency with glomerular filtration rate (GFR) ≤ 60 mL/min/1.73 m²;
- Pregnant and lactating women or female patients plan to become pregnant within 6 months;
- Uncontrolled psychiatric disorders;
- Vulnerable population (e.g., being in detention) or have a serious non-malignant disease (e.g., infectious disease, autoimmune disease, or metabolic disease).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Peking University First Hospital — Beijing
Identifiers
NCT: NCT06519760 · 2024#07-17