NCT06715826

Target-specific immunoPET Imaging of Breast Cancer

Development and Clinical Translation of immunoPET Imaging Probes for Breast Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer
• Breast Neoplasms
• Breast Cancer Metastatic

Interventions

Type	Name	Description
DRUG	[18F]F-RESCA-RT4	Enrolled patients will receive 0.05-0.1mCi/kg of \[18F\]F-RESCA-RT4. ImmunoPET/CT imaging will be acquired 1 hour after \[18F\]F-RESCA-RT4 injection.
DRUG	[18F]F-RESCA-RB14	Enrolled patients will receive 0.05-0.1mCi/kg of \[18F\]F-RESCA-RB14. ImmunoPET/CT imaging will be acquired 1 hour after \[18F\]F-RESCA-RB14 injection.

Timeline

• Start date: 2024-09-21
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2024-12-04
• Last updated: 2026-01-27

Locations

1 site across 1 country: China