Clinical trial · Observational
Exploring the Clinical Application Value of CAIX-Targeted PET Imaging in Renal Cancer Patients
NCT06956144CI-TRIAL-00090272recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carbonic Anhydrase IX | — | UNRESOLVED | — |
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Experimental: CAIX-PET/CT
- description
- Each participant receives a single intravenous injection of CAIX-PET/CT, and undergo PET/CT imaging within the specified time.
Primary outcomes (1)
- measure
- Evaluate the clinical diagnostic efficacy
- timeFrame
- 3 Months
- description
- To evaluate the clinical diagnostic efficacy (sensitivity, specificity, accuracy) of targeted CAIX PET/CT imaging in the diagnosis and staging of kidney cancer
Secondary outcomes (1)
- measure
- Assess the clinical added value
- timeFrame
- 6 Months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.