Breast CancerBreast NeoplasmsBreast Cancer Metastatic
Investigational drug(s) / intervention(s)
[18F]F-RESCA-RT4[18F]F-RESCA-RB14
[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.
[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.
Study 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
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Aged 18-75 years old and of female gender；
2. Histologically confirmed diagnosis of breast cancer or suspected breast cancer by diagnostic imaging;
3. Capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.
Exclusion Criteria:
1. Pregnancy；
2. Severe hepatic and renal insufficiency;
3. History of serious surgery in the last month;
4. Allergic to antibody or single-domain antibody radiopharmaceuticals.
Primary outcome measure(s)
Biodistribution of [18F]F-RESCA-RT4/ [18F]F-RESCA-RB14 — 1 day from injection of the tracer Measurement of the overall biodistribution of above probes in normal tissues and organs.
Standardized uptake value (SUV) — 1 day from injection of the tracer Standardized uptake value (SUV) of \[18F\]F-RESCA-RT4/ \[18F\]F-RESCA-RB14 in the included subjects' primary and/or metastatic lesions.
Radiation dosimetry of [18F]F-RESCA-RT4/[18F]F-RESCA-RB14 — 1 day from injection of the tracer Measurement of absorbed radiation doses (Gy/MBq) to tissues/organs, tumor(s), and whole body (Sv/MBq). Dynamic imaging within one hour will be acquired for the purpose.
The correlation between Trop2 expression and [18F]F-RESCA-RT4 uptake value — 60 days The Standardized uptake value (SUV) of \[18F\]F-RESCA-RT4 will be calculated, and the correlation between pathological results and tumor uptake of\[18F\]F-RESCA-T4 will be analyzed.
The correlation between HER2 expression and [18F]F-RESCA-RB14 uptake value — 60 days Standardized uptake value (SUV) of \[18F\]F-RESCA-RB14 will be calculated, and the correlation between pathological results and tumor uptake of \[18F\]F-RESCA-RB14 will be analyzed.
Diagnostic value of Trop2/HER2-targeted immunPET in patients with breast cancer — 30 days We will calculate the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of \[18F\]F-RESCA-RT4/\[18F\]F-RESCA-RB14 PET/CT in patients with breast cancer. We will also compare the diagnostic value of above probes with that of traditional imaging tracers (e.g., 18F-FDG) and imaging modalities (e.g., MRI). All the above goals will be achieved by analyzing the static/dynamic\[18F\]F-RESCA-RT4/\[18F\]F-RESCA-RB14 PET/CT imaging data. Systematic evaluation of these parameters will elucidate the pharmacokinetics, pharmacodynamics, and, more importantly, the clinical value of \[18F\]F-RESCA-RT4/\[18F\]F-RESCA-RB14 PET/CT for patients with breast cancer.
Trial sites (1)
Facility
City
Region
Status
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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