RecruitingPhase 1Phase 2NCT06715826

Target-specific immunoPET Imaging of Breast Cancer

Development and Clinical Translation of immunoPET Imaging Probes for Breast Cancer


Sponsor

RenJi Hospital

Enrollment

200 participants

Start Date

Sep 21, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Inclusion Criteria3

  • Aged 18-75 years old and of female gender;
  • Histologically confirmed diagnosis of breast cancer or suspected breast cancer by diagnostic imaging;
  • Capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.

Exclusion Criteria4

  • Pregnancy;
  • Severe hepatic and renal insufficiency;
  • History of serious surgery in the last month;
  • Allergic to antibody or single-domain antibody radiopharmaceuticals.

Interventions

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.


Locations(1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

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NCT06715826


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