Renal Cell CarcinomaEarly Phase 1CAIX-PETNCT07875946
68Ga- and 18F-CAIX PET Imaging Study
A Early Phase 1 study testing 68Ga-CAIX PET/CT and 18F-CAIX in people with Renal Cell Carcinoma and Clear Cell Renal Cell Carcinoma, run by Peking University First Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Renal Cell Carcinoma, Clear Cell Renal Cell Carcinoma, Renal Tumor
- What is being tested?
- 68Ga-CAIX PET/CT and 18F-CAIX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2026to 31 Dec 2028
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Nuclear Medicine, Peking University First Hospital
Beijing, Beijing Municipality, 010000
Tingting Yuan, M.D., 010-83575252, biluohtt@163.com
About this study
Official title: 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.
- Being tested
- 68Ga-CAIX PET/CT, 18F-CAIX
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-CAIX PET/CTDrug
68Ga-labeled CAIX-targeted PET tracer administered as a single intravenous injection at approximately 0.08-0.10 mCi/kg, followed by PET/CT imaging approximately 1 hour after administration.
18F-CAIXDrug
18F-labeled CAIX-targeted PET tracer administered as a single intravenous injection at approximately 0.08-0.10 mCi/kg, followed by PET/CT imaging approximately 1 hour after administration.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-CAIX PET/CT | Experimental | Participants randomized to this arm will receive a single intravenous administration of 68Ga-CAIX followed by PET/CT imaging approximately 1 hour after tracer administration. Participants will also undergo 18F-FDG PET/CT approximately 48 hours before or after the 68Ga-CAIX PET/CT examination according to the randomized imaging sequence. Receives: Drug: 68Ga-CAIX PET/CT |
| 18F-CAIX PET/CT | Experimental | Participants randomized to this arm will receive a single intravenous administration of 18F-CAIX followed by PET/CT imaging approximately 1 hour after tracer administration. Participants will also undergo 18F-FDG PET/CT approximately 48 hours before or after the 18F-CAIX PET/CT examination according to the randomized imaging sequence. Receives: Drug: 18F-CAIX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semiquantitative Uptake of CAIX-Targeted Tracers
CAIX-targeted tracer uptake will be quantified using the maximum standardized uptake value (SUVmax) measured by PET/CT in predefined normal organs and tumor lesions.
Measured: During the PET/CT examination, approximately 60 minutes after 18F-CAIX or 68Ga-CAIX administration.
Secondary outcomes (8)
Incidence of Adverse Events
The incidence of adverse events occurring after administration of 68Ga-CAIX or 18F-CAIX will be recorded to assess the safety and tolerability of the CAIX-targeted tracers.
Measured: From tracer administration through 24 hours after PET/CT imaging.
Correlation Between CAIX PET Uptake and CAIX Immunohistochemical Expression
The correlation between CAIX PET uptake, measured by SUVmax on CAIX-targeted PET/CT, and CAIX immunohistochemical expression, quantified using the H-score, will be assessed using the Spearman correlation coefficient.
Measured: Within 4 weeks after PET/CT examination, at the time of pathological evaluation.
Number of Lesions Detected by CAIX-Targeted PET/CT
The number of tumor lesions detected by 68Ga-CAIX or 18F-CAIX PET/CT will be recorded and compared with the number of lesions identified by 18F-FDG PET/CT and available clinical, pathological, and imaging reference standards.
Measured: During the PET/CT examination, approximately 60 minutes after 18F-CAIX or 68Ga-CAIX administration.
Sensitivity of CAIX-Targeted PET/CT for Lesion Detection
The sensitivity of 68Ga-CAIX or 18F-CAIX PET/CT for detecting tumor lesions will be calculated as the percentage of reference-standard-positive lesions correctly identified by CAIX-targeted PET/CT.
Measured: From the PET/CT examination until completion of the clinical, pathological, and imaging reference standard assessment, within 4 weeks after PET/CT.
Specificity of CAIX-Targeted PET/CT for Lesion Detection
The specificity of 68Ga-CAIX or 18F-CAIX PET/CT for detecting tumor lesions will be calculated as the percentage of reference-standard-negative lesions correctly identified as negative by CAIX-targeted PET/CT.
Measured: From the PET/CT examination until completion of the clinical, pathological, and imaging reference standard assessment, within 4 weeks after PET/CT.
Accuracy of CAIX-Targeted PET/CT for Lesion Detection
The accuracy of 68Ga-CAIX or 18F-CAIX PET/CT for lesion detection will be calculated as the percentage of lesions correctly classified as positive or negative according to the clinical, pathological, and imaging reference standards.
Measured: From the PET/CT examination until completion of the clinical, pathological, and imaging reference standard assessment, within 4 weeks after PET/CT.
False-Positive Rate of CAIX-Targeted PET/CT for Lesion Detection
The false-positive rate of 68Ga-CAIX or 18F-CAIX PET/CT for lesion detection will be calculated as the percentage of reference-standard-negative lesions incorrectly identified as positive by CAIX-targeted PET/CT.
Measured: From the PET/CT examination until completion of the clinical, pathological, and imaging reference standard assessment, within 4 weeks after PET/CT.
False-Negative Rate of CAIX-Targeted PET/CT for Lesion Detection
The false-negative rate of 68Ga-CAIX or 18F-CAIX PET/CT for lesion detection will be calculated as the percentage of reference-standard-positive lesions incorrectly identified as negative by CAIX-targeted PET/CT.
Measured: From the PET/CT examination until completion of the clinical, pathological, and imaging reference standard assessment, within 4 weeks after PET/CT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875946
- Sponsor's protocol ID
- CAIX 001
- Acronym
- CAIX-PET
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data underlying the results reported in the study, after de-identification.