NCT07875946Not yet recruitingEarly phase 1
68Ga- and 18F-CAIX PET Imaging Study
A Prospective Randomized Study of 68Ga- and 18F-Labeled CAIX-Targeted PET/CT Imaging in Patients With Renal Tumors
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 24 Sept 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Peking University First Hospital
- Diseases
- Kidney cancer
- NCT number
- NCT07875946
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 100
- From 1 Oct 2026 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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.
- 4\. Renal dysfunction with an estimated glomerular filtration rate (eGFR) ≤60 mL/min/1.73 m².
- 5\. Uncontrolled psychiatric disorders that may interfere with study participation.
- 6\. 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.
- 8\. Individuals belonging to vulnerable populations.
Who the study is looking for
- \- 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.
- 4\. 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Nuclear Medicine, Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.