Carbonic Anhydrase IX, Clear Cell Renal Cell Carcinoma, PET-CT
Conditions
Keywords
Carbonic Anhydrase IX, 68Ga-C1, PET-CT, Clear Cell Renal Cell Carcinoma
Brief summary
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
DRUG68Ga-C1
68Ga-C1 is injected intravenously with a dose of 0.05-0.10 mCi/kg
Sponsors
Peking University First Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Signed written informed consent； 2. Age ≥18； 3. Patients with confirmed or suspected clear cell renal cell carcinoma; 4. Expected survival ≥6 months.
Exclusion criteria
1. Renal mass is known to be a metastasis of another primary tumor; 2. Have other malignancies that require treatment; 3. Have received chemotherapy, radiotherapy, or immunotherapy within 4 weeks; 4. Renal insufficiency with glomerular filtration rate (GFR) ≤ 60 mL/min/1.73 m²; 5. Pregnant and lactating women or female patients plan to become pregnant within 6 months; 6. Uncontrolled psychiatric disorders; 7. Vulnerable population (e.g., being in detention) or have a serious non-malignant disease (e.g., infectious disease, autoimmune disease, or metabolic disease).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The diagnostic efficacy of 68Ga-C1 PET/CT in the evaluation of clear cell renal cell carcinoma | 1 year | Compare the standardized Uptake Value (SUV) of lesions on 68Ga-C1 and 18F-FDG PET/CT |
| The diagnostic efficacy of 68Ga-C1 PET/CT in the evaluation of malignant tumors | 1 year | Compare the number of lesions detected by 68Ga-C1 and 18F-FDG PET/CT, based on the pathology or clinical follow-up as gold standard. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The dosimetry of 68Ga-C1 | 1 year | Research on the dose distribution of 68Ga-C1 in healthy volunteers and cancer patients by 1-hour dynamic PET/CT acquisition and analyze by the dosimetry software |
| Quantitative evaluation of 68Ga-C1 | 1 year | Evaluation of quantitative parameters of 68Ga-C1, such as time-activity curve. |
| Correlation with pathological expression | 1 year | Analyze CAIX expression at the imaging level in combination with CAIX expression in pathological specimens |
Countries
China
Contacts
Primary ContactKan Gong
Outcome results
None listed