Using CAIX-targeted PET imaging for kidney cancer diagnosis

Exploring the Clinical Application Value of CAIX-Targeted PET Imaging in Renal Cancer Patients

This study is testing a new type of PET imaging that targets kidney cancer to see if it can improve how doctors diagnose and stage the disease compared to regular CT scans.

Quick facts

• Study type: Observational
• Enrollment: 113 (estimated)
• Ages: 18 Years to 74 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Xiamen University (Academic / other)
• Locations: 1 site (Xiamen)
• Trial ID: NCT06956144 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of CAIX-targeted PET imaging in diagnosing and staging kidney cancer. It involves analyzing images by experienced physicians and comparing the results with histopathological findings from biopsies or surgeries. The study aims to assess the imaging's role in prognosis prediction and treatment evaluation by measuring various diagnostic metrics. Statistical methods will be employed to compare the performance of this imaging technique against enhanced CT scans.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with clinically suspected or confirmed primary kidney cancer.

Not a fit: Patients with non-renal cancers or those who do not meet the eligibility criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve the accuracy of kidney cancer diagnosis and staging, leading to better treatment outcomes.

How similar studies have performed: While there have been studies on PET imaging in cancer, the specific application of CAIX-targeted imaging in renal cancer is relatively novel.

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.

Where this trial is running

Xiamen

• The First Affiliated Hospital of Xiamen University, Xiamen, Fujian 361000 — Xiamen, China (Recruiting)

Study contacts

• Study coordinator: Haojun Chen

Conditions Tumor; Carbonic Anhydrase IX; PET; CAIX; Renal Cancer; diagnosis