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Trial Title:
68Ga-C1 PET/ CT Imaging in Clear Cell Renal Cell Carcinoma
NCT ID:
NCT06519760
Condition:
Carbonic Anhydrase IX
PET-CT
Clear Cell Renal Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Conditions: Keywords:
Carbonic Anhydrase IX
68Ga-C1
PET-CT
Clear Cell Renal Cell Carcinoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
68Ga-C1
Description:
68Ga-C1 is injected intravenously with a dose of 0.05-0.10 mCi/kg
Arm group label:
68Ga-C1
Other name:
CAIX specific PET imaging
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.
Criteria for eligibility:
Criteria:
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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Peking University First Hospital
Address:
City:
Beijing
Zip:
100034
Country:
China
Status:
Recruiting
Contact:
Last name:
Yanyan Yu
Phone:
+86 1066119025
Email:
bdyyll@126.com
Start date:
July 30, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Peking University First Hospital
Agency class:
Other
Source:
Peking University First Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06519760
