Clinical trial NCT06956144: Exploring the Clinical Application Value of CAIX-Targeted PET Imaging in Renal Cancer Patients
Official title: Exploring the Clinical Application Value of CAIX-Targeted PET Imaging in Renal Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tumor
Carbonic Anhydrase IX
Keywords: PET
CAIX
Renal Cancer
diagnosis
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
First posted: 2025-05-02
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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 kidney cancer.

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 measure volume and SUV values. The interpreted PET/CT imaging results will be compared to the corresponding histopathological results of the lesions (obtained through biopsy or surgery) and will be used as the reference standard. We will employ McNemar's test to compare the sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of targeted CAIX PET/CT imaging and enhanced CT in primary tumors, metastatic lymph nodes, and distant metastatic lesions.

Eligibility criteria: 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 outcomes:
measure: Evaluate the clinical diagnostic efficacy
timeFrame: 3 Months
Secondary outcomes:
measure: Assess the clinical added value
timeFrame: 6 Months
Other outcomes:
Locations:
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University, Xiamen, Fujian 361000
Study officials:
References: