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Not yet taking people in ChinaEarly phase 1

Two CAIX-targeted PET scan tracers in people with kidney tumors

Tests two CAIX-targeted PET/CT scan tracers in adults with kidney tumors.

Plain-language title generated from the registry record
Registry title: 68Ga- and 18F-CAIX PET Imaging Study

Key facts

Where
Beijing, ChinaSee the site
Phase
Early phase 1

Where in China

  • Department of Nuclear Medicine, Peking University First HospitalBeijing, ChinaNo longer taking part

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Trial details

Who runs it
Peking University First Hospital
Trial code
NCT07875946
Record updated
15 October 2026
Original description
This exploratory clinical imaging study will evaluate the safety, tolerability, biodistribution, lesion detection, and tumor uptake characteristics of 68Ga- and 18F-labeled carbonic anhydrase IX (CAIX)-targeted positron emission tomography/computed tomography (PET/CT) in patients with renal tumors or suspected renal cell carcinoma. Participants will be randomly assigned to receive either 68Ga-CAIX or 18F-CAIX PET/CT. All participants will also undergo 18F-FDG PET/CT for comparison. The study will further explore the association between CAIX-targeted PET findings and CAIX expression assessed by immunohistochemistry, as well as the diagnostic performance of CAIX-targeted PET/CT for lesion detection.Read full original descriptionShow less

A Prospective Randomized Study of 68Ga- and 18F-Labeled CAIX-Targeted PET/CT Imaging in Patients With Renal Tumors

This exploratory clinical imaging study will evaluate the safety, tolerability, biodistribution, lesion detection, and tumor uptake characteristics of 68Ga- and 18F-labeled carbonic anhydrase IX (CAIX)-targeted positron emission tomography/computed tomography (PET/CT) in patients with renal tumors or suspected renal cell carcinoma. Participants will be randomly assigned to receive either 68Ga-CAIX or 18F-CAIX PET/CT. All participants will also undergo 18F-FDG PET/CT for comparison. The study will further explore the association between CAIX-targeted PET findings and CAIX expression assessed by immunohistochemistry, as well as the diagnostic performance of CAIX-targeted PET/CT for lesion detection.

Inclusion: 1. Adults aged 18 years or older. 2. Voluntarily provide written informed consent before participation. 3. Patients with an indeterminate renal mass, suspected renal cell carcinoma, previously diagnosed clear cell renal cell carcinoma, or suspected recurrent renal cell carcinoma based on clinical or imaging findings; Estimated life expectancy of at least 6 months. 5. Participants of childbearing potential must use appropriate and highly effective contraception for at least 35 days after administration of the study tracer.

Exclusion: 1. Renal tumor known to represent metastasis from another primary malignancy. 2. Other active malignancies requiring treatment. 3. Chemotherapy, radiotherapy, or immunotherapy within 4 weeks before study enrollment; Renal dysfunction with an estimated glomerular filtration rate (eGFR) ≤60 mL/min/1.73 m²; Uncontrolled psychiatric disorders that may interfere with study participation; Pregnancy or breastfeeding. 7. Severe nonmalignant diseases, including infectious, autoimmune, or metabolic diseases, that in the investigator's opinion may interfere with the study objectives, participant safety, or study compliance; Individuals belonging to vulnerable populations.

ClinicalTrials.gov NCT07875946