An Early Phase 1 interventional study of 68Ga-CAIX PET/CT and 18F-CAIX in Renal Cell Carcinoma, Clear Cell Renal Cell Carcinoma and Renal Tumor, sponsored by Peking University First Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Peking University First Hospital · Early Phase 1, Interventional, and Diagnostic
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.
1,992 studies on the registry are indexed under Carcinoma, Renal Cell; 387 are open to participants now.
This study's planned enrollment of 100 is above the median of 42 across 1,501 interventional studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →Peking University First Hospital is the lead sponsor of 386 studies on the registry; 182 are open to participants now.
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- 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.
Exclusion Criteria:
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.
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.
Drug: 68Ga-CAIX PET/CT
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.
Drug: 18F-CAIX
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-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.
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.
Time frame: During the PET/CT examination, approximately 60 minutes after 18F-CAIX or 68Ga-CAIX administration.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From the PET/CT examination until completion of the clinical, pathological, and imaging reference standard assessment, within 4 weeks after PET/CT.
Plan to share: Yes — Individual participant data underlying the results reported in the study, after de-identification.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 12 months after publication of the study results and ending 36 months after publication.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Dec 2028, 26 months later.
Of 79 non-industry phase 1 interventional studies under Carcinoma, Renal Cell, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 75. This study's planned 26 months is below that.
Counting every sponsor, half of 200 studies reached it within 51 months; a quarter within 32 and three quarters within 74.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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