68Ga-C1 PET/ CT Imaging in Clear Cell Renal Cell Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University First Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Signed written informed consent；
Age ≥18；
Patients with confirmed or suspected clear cell renal cell carcinoma;
Expected survival ≥6 months.
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
68Ga-C1
Drug68Ga-C1 is injected intravenously with a dose of 0.05-0.10 mCi/kg
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: 68Ga-C1Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The diagnostic efficacy of 68Ga-C1 PET/CT in the evaluation of clear cell renal cell carcinoma
Compare the standardized Uptake Value (SUV) of lesions on 68Ga-C1 and 18F-FDG PET/CT
Time frame
1 year2
The diagnostic efficacy of 68Ga-C1 PET/CT in the evaluation of malignant tumors
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.
Time frame
1 yearSecondary outcomes
1
The dosimetry of 68Ga-C1
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
Time frame
1 year2
Quantitative evaluation of 68Ga-C1
Evaluation of quantitative parameters of 68Ga-C1, such as time-activity curve.
Time frame
1 year3
Correlation with pathological expression
Analyze CAIX expression at the imaging level in combination with CAIX expression in pathological specimens
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov