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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trop2/HER2-targeted immunoPET imaging | Experimental | Enrolled patients will undergo a Trop2/HER2-targeted immunoPET/CT scanning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]F-RESCA-RT4 | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biodistribution of [18F]F-RESCA-RT4/ [18F]F-RESCA-RB14 | Measurement of the overall biodistribution of above probes in normal tissues and organs. | 1 day from injection of the tracer |
| Standardized uptake value (SUV) | Standardized uptake value (SUV) of [18F]F-RESCA-RT4/ [18F]F-RESCA-RB14 in the included subjects' primary and/or metastatic lesions. | 1 day from injection of the tracer |
| Radiation dosimetry of [18F]F-RESCA-RT4/[18F]F-RESCA-RB14 | 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. | 1 day from injection of the tracer |
| The correlation between Trop2 expression and [18F]F-RESCA-RT4 uptake value | 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. | 60 days |
| The correlation between HER2 expression and [18F]F-RESCA-RB14 uptake value | 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. | 60 days |
| Diagnostic value of Trop2/HER2-targeted immunPET in patients with breast cancer | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The predictive value of [18F]F-RESCA-RT4/ [18F]F-RESCA-RB14 in the course of targeted therapies | Baseline and follow-up [18F]F-RESCA-RT4/ [18F]F-RESCA-RB14 immunoPET imaging in targeted therapy will be investigated in this setting to determine the value of Trop2/HER2 immunoPET imaging in predicting or evaluating treatment responses. | 3-6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weijun Wei, Ph.D. & M.D. | Contact | 15000083153 | wwei@shsmu.edu.cn | |
| Wenzhi Jia, Ph.D. & M.D. | Contact | 18317076979 | jwzdata@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Weijun Wei, Ph.D. & M.D. | Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital, School of Medicine, Shanghai Jiao Tong University | Recruiting | Shanghai | Shanghai Municipality | 200127 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| [18F]F-RESCA-RB14 | Drug | 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. |
|
|
| 30 days |
| Trop2/HER2-targeted immunPET in changing clinical decision-making for patients with breast cancer | After analyzing the imaging parameters and diagnostic/predictive value of [18F]F-RESCA-RT4/[18F]F-RESCA-RB14 PET/CT, we will also investigate how clinical use of [18F]F-RESCA-RT4/[18F]F-RESCA-RB14 PET/CT changes clinical decision-making for patients with breast cancer. Joint efforts from nuclear medicine physicians, breast surgeons, oncologists, and pathologists will draw solid conclusions from the imaging and clinical information. | 3-6 months |
| D017437 |
| Skin and Connective Tissue Diseases |