Status:
RECRUITING
Exploring the Clinical Application Value of CAIX-Targeted PET Imaging in Renal Cancer Patients
Lead Sponsor:
The First Affiliated Hospital of Xiamen University
Conditions:
Tumor
Carbonic Anhydrase IX
Eligibility:
All Genders
18-74 years
Brief 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 k...
Detailed Description
Images will be analyzed by at least two physicians with extensive experience in nuclear medicine and radiological diagnostics. Regions of interest (ROIs) will be delineated for the lesion tissues to m...
Eligibility Criteria
Inclusion
- 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.
- ECOG performance status score of 0-3.
- Laboratory parameters must meet the following criteria:
- 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.
- Hematological parameters: 2 x 10\^9/L ≤ WBC ≤ 2 x 10\^10/L, PLT ≥ 80 x 10\^9/L, Hb ≥ 80 g/L.
- Willing and able to comply with follow-up visits, treatment plans, and related laboratory examinations.
Exclusion
- 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.).
- Researchers believe that the patient has poor compliance or has other factors making them unsuitable for participation in this study.
Key Trial Info
Start Date :
May 9 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT06956144
Start Date
May 9 2025
End Date
September 30 2026
Last Update
May 29 2025
Active Locations (1)
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1
The First Affiliated Hospital of Xiamen University, Xiamen, Fujian 361000
Xiamen, China