The First Affiliated Hospital of Xiamen University
Phase
Observational
Started
2025-05-09
Last updated
2025-05-29
Condition(s) studied
TumorCarbonic Anhydrase IX
Study summary
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
Sex
ALL
Min age
18 Years
Max age
74 Years
Healthy volunteers
Accepted
Inclusion Criteria:
1. Voluntary participation with the patient or their legal representative able to sign the informed consent form.
2. Adult patients (age between 18 and 75 years), regardless of gender.
3. 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).
4. Patients must have undergone enhanced CT, with the enhanced CT examination conducted within 2 weeks prior to enrollment.
5. ECOG performance status score of 0-3.
6. 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.
7. Willing and able to comply with follow-up visits, treatment plans, and related laboratory examinations.
Exclusion Criteria:
1. 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).
2. Patients or their legal representatives who are unable or unwilling to sign the informed consent form.
3. Acute systemic diseases and electrolyte imbalances.
4. Patients unable to complete the PET/CT examination (including those unable to lie flat, those with claustrophobia, radiophobia, etc.).
5. Researchers believe that the patient has poor compliance or has other factors making them unsuitable for participation in this study.
Primary outcome measure(s)
Evaluate the clinical diagnostic efficacy — 3 Months To evaluate the clinical diagnostic efficacy (sensitivity, specificity, accuracy) of targeted CAIX PET/CT imaging in the diagnosis and staging of kidney cancer
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Xiamen University, Xiamen, Fujian 361000
Xiamen
China
Recruiting
More The First Affiliated Hospital of Xiamen University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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