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

NCT06956144 | Recruiting

• 1 other identifier: XMFHIIT-2025SL048
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Tumor; Carbonic Anhydrase IX

Keywords

PET; CAIX; Renal Cancer; diagnosis

Outcome Measures

Primary Outcomes (1)

• Evaluate the clinical diagnostic efficacy

  To evaluate the clinical diagnostic efficacy (sensitivity, specificity, accuracy) of targeted CAIX PET/CT imaging in the diagnosis and staging of kidney cancer

  3 Months

Secondary Outcomes (1)

• Assess the clinical added value

  6 Months

Study Arms (1)

Experimental: CAIX-PET/CT

Each participant receives a single intravenous injection of CAIX-PET/CT, and undergo PET/CT imaging within the specified time.

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

The First Affiliated Hospital of Xiamen University, Xiamen, Fujian 361000

Xiamen, China

RECRUITING

MeSH Terms

Conditions

Neoplasms; Kidney Neoplasms; Disease

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Haojun Chen

CONTACT

86-592-2137077; leochen0821@foxmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 2, 2025
• Study Start: May 9, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)