68Ga- and 18F-CAIX PET Imaging Study

NCT07875946 | Not Yet Recruiting Early Phase 1

• 1 other identifier: CAIX 001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Renal Cell Carcinoma; Clear Cell Renal Cell Carcinoma; Renal Tumor

Outcome Measures

Primary Outcomes (1)

• 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.

  During the PET/CT examination, approximately 60 minutes after 18F-CAIX or 68Ga-CAIX administration.

Secondary Outcomes (8)

• Incidence of Adverse Events

  From tracer administration through 24 hours after PET/CT imaging.

• Correlation Between CAIX PET Uptake and CAIX Immunohistochemical Expression

  Within 4 weeks after PET/CT examination, at the time of pathological evaluation.

• Number of Lesions Detected by CAIX-Targeted PET/CT

  During the PET/CT examination, approximately 60 minutes after 18F-CAIX or 68Ga-CAIX administration.

• Sensitivity of CAIX-Targeted PET/CT for Lesion Detection

  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

  From the PET/CT examination until completion of the clinical, pathological, and imaging reference standard assessment, within 4 weeks after PET/CT.

Study Arms (2)

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.

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.

Drug: 18F-CAIX

Interventions

68Ga-CAIX PET/CT DRUG

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.

68Ga-CAIX PET/CT

18F-CAIX DRUG

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.

18F-CAIX PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Department of Nuclear Medicine, Peking University First Hospital

Beijing, Beijing Municipality, 010000, China

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Tingting Yuan, M.D.

CONTACT

13051707479; biluohtt@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: October 15, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 12 months after publication of the study results and ending 36 months after publication.

Locations

CN (1)