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NCT Number: NCT06956144

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

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.

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Key information

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Xiamen, China

Location status: Recruiting

Location contact

Haojun Chen

CONTACT

[email protected]

86-592-2137077

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Evaluate the clinical diagnostic efficacy

    Time frame: 3 Months

    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. Assess the clinical added value

    Time frame: 6 Months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Haojun Chen

CONTACT

[email protected]

86-592-2137077

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Xiamen University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 2, 2025
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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