TheranosticTrials.org

Clinical Trial · NCT07875946

68Ga- and 18F-CAIX PET Imaging Study

Overview

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.

Sponsor

Peking University First Hospital

Phase

Early Phase 1

Contacts

Tingting Yuan, M.D. (CONTACT)

biluohtt@163.com

13051707479

ClinicalTrials.gov

NCT07875946

Drug / Compound

CAIX

Isotope(s):
Target(s):
  • CAIX
Ligand Class: Small Molecules

CAIX

Isotope(s):
Target(s):
  • CAIX
Ligand Class: Small Molecules

FDG

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules

Eligibility

Inclusion

Inclusion criteria not yet provided.

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. 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.