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Development and Clinical Translation of immunoPET Imaging Probes for Breast Cancer
The aim of this study is to establish and optimize the Trop2/HER2-targeted PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in breast cancer will be evaluated.
Enrolled patients will undergo whole-body\[18F\]F-RESCA-RT4(Trop2-targeted imaging probes ) or \[18F\]F-RESCA-RB14(HER2-targeted imaging probes) PET/CT scans at 1 hours after tracer injection(0.05-0.1 mCi/kg). Uptake of above imaging agents in tumor and normal organs/tissues will be scored visually and quantitatively. Tumor uptake will be quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy will be calculated to evaluate the diagnostic efficacy. The correlation between lesion uptake and protein expression level determined by immunohistochemistry staining will be further analyzed. The exploration endpoint will be the imaging feasibility and preliminary diagnostic value of the above tracers.
Age
18 - 75 years
Sex
FEMALE
Healthy Volunteers
No
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
Start Date
September 21, 2024
Primary Completion Date
November 1, 2026
Completion Date
November 1, 2026
Last Updated
January 27, 2026
200
ESTIMATED participants
[18F]F-RESCA-RT4
DRUG
[18F]F-RESCA-RB14
DRUG
Lead Sponsor
RenJi Hospital
NCT05245812
NCT04550494
Data Source & Attribution
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