Exploring the Clinical Application Value of CAIX-Targeted PET Imaging in Renal Cancer Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-74
SponsorThe First Affiliated Hospital of Xiamen University
About this trial
To evaluate the efficacy of targeted CAIX-specific probe PET imaging in the diagnosis and staging of kidney cancer, as well as to assess its role in prognosis prediction and treatment evaluation for kidney cancer.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Voluntary participation with the patient or their legal representative able to sign the informed consent form.
Adult patients (age between 18 and 75 years), regardless of gender.
Patients with clinically suspected or confirmed primary kidney cancer (supporting evidence includes imaging data and histopathological examination; specific case types include clear cell carcinoma, papillary renal cell carcinoma, and chromophobe renal cell carcinoma) who agree to undergo histopathological examination (if not already performed prior to imaging).
Patients must have undergone enhanced CT, with the enhanced CT examination conducted within 2 weeks prior to enrollment.
Disqualifiers
Pregnant or breastfeeding patients (all women of childbearing age must undergo pregnancy testing during the screening phase, such as a urine pregnancy test or blood HCG test, to confirm their pregnancy status).
Patients or their legal representatives who are unable or unwilling to sign the informed consent form.
Acute systemic diseases and electrolyte imbalances.
Patients unable to complete the PET/CT examination (including those unable to lie flat, those with claustrophobia, radiophobia, etc.).
Trial population
1. Adult patients (age between 18 and 75 years), regardless of gender. 2. Patients with clinically suspected or confirmed primary kidney cancer (supporting evidence includes imaging data and histopathological examination; specific case types include clear cell carcinoma, papillary renal cell carcinoma, and chromophobe renal cell carcinoma) who agree to undergo histopathological examination (if not already performed prior to imaging). 3. Patients must have undergone enhanced CT, with the enhanced CT examination conducted within 2 weeks prior to enrollment. 4. ECOG performance status score of 0-3. 5. Laboratory parameters must meet the following criteria: 1. ALT and AST must not exceed 3 times the upper limit of normal; BUN and creatinine must not exceed 1.5 times the upper limit of normal. 2. Hematological parameters: 2 x 10\^9/L ≤ WBC ≤ 2 x 10\^10/L, PLT ≥ 80 x 10\^9/L, Hb ≥ 80 g/L.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
113 Participants
are grouped into 1 trial groupGroup A: Experimental: CAIX-PET/CT
Trial outcomes
Primary outcomes
1
Evaluate the clinical diagnostic efficacy
To evaluate the clinical diagnostic efficacy (sensitivity, specificity, accuracy) of targeted CAIX PET/CT imaging in the diagnosis and staging of kidney cancer
Time frame
3 MonthsSecondary outcomes
1
Assess the clinical added value
To assess the clinical added value of targeted CAIX PET/CT molecular imaging technology in the diagnosis and staging of kidney cancer by comparing it with enhanced CT.
Time frame
6 MonthsSponsors and contacts
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Source ClinicalTrials.gov