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| Name | Class |
|---|---|
| Ministry of Health & Welfare, Korea | OTHER_GOV |
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The purpose of this study is:
To validate the efficacy of multiparametric MRI, FDG-PET, RGD-PET, and PET-MR fusion imaging in the prediction and monitoring response to neoadjuvant chemotherapy of locally advanced breast cancer patients.
To identify the optimal combination parameters of MR spectroscopy, diffusion-weighted MRI, dynamic contrast-enhanced MRI, FDG-PET, and RGD-PET in the prediction and monitoring response to neoadjuvant chemotherapy of locally advanced breast cancer patients.
To compare the performances of dynamic contrast-enhanced MRI using parametric response map analysis versus those of pharmacokinetic parameters (Ktrans, kep, or Ve) in the early prediction of pathological responsiveness to neoadjuvant chemotherapy in breast cancer patients
Enrolled women with breast cancers who had received an anthracycline-taxane regimen and subsequent surgery were prospectively enrolled. DCE-MRI and FDG-PET scan were performed before and after the 1st cycle of chemotherapy. MR imaging parameters and SUV on PET scan within a tumor were analyzed. Clinicopathologic (age, clinical tumor stage, hormonal receptor status, and surgery type) and imaging parameters were compared according to the pathological response.
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| Measure | Description | Time Frame |
|---|---|---|
| Patholocial Response to Chemotherapy | Pathological complete response (pCR) or non-pCR | Post-operation |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Size | Maximal tumor diameter measured on magnetic resonance imaging | baseline, completion of 1st cycle of chemotherapy |
| Tumor Volume | Tumor volume measured on 3-dimensional magnetic resonance imaging |
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Inclusion Criteria:
Exclusion Criteria:
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Breast cancer patients who are candidates for neoadjuvant chemotherapy, pre-treatment MRI and PET scan, post-treatment MRI and PET scan for evaluation of chemotherapy response monitoring and residual disease
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| Name | Affiliation | Role |
|---|---|---|
| Woo Kyung Moon, M.D., Ph.D. | Department of Radiology, Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24738612 | Derived | Cho N, Im SA, Park IA, Lee KH, Li M, Han W, Noh DY, Moon WK. Breast cancer: early prediction of response to neoadjuvant chemotherapy using parametric response maps for MR imaging. Radiology. 2014 Aug;272(2):385-96. doi: 10.1148/radiol.14131332. Epub 2014 Apr 13. |
| Label | URL |
|---|---|
| Homepage of Seoul National University Hospital Biomedical Research Institute | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pathologic Complete Responders (pCR) | The absence of invasive tumor cells (ductal carcinoma in situ may have been present) after surgery. |
| FG001 | Non-pCR | The presence of invasive tumor cells (ductal carcinoma in situ may have been present) after surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pathologic Complete Responders (pCR) | The absence of invasive tumor cells (ductal carcinoma in situ may have been present) after surgery. |
| BG001 | Non-pCR | The presence of invasive tumor cells (ductal carcinoma in situ may have been present) after surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patholocial Response to Chemotherapy | Pathological complete response (pCR) or non-pCR | Posted | Number | participants | Post-operation |
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Baseline, post-1st chemotherapy, preoperative timing
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pathologic Complete Responders (pCR) | the absence of invasive tumor cells after surgery |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Woo Kyung Moon | Seoul National University Hospital | 82-2-2072-2584 | moonwk@snu.ac.kr |
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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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Core biopsy specimens of breast cancer
| Baseline, post-1st chemotherapy |
| Proportions of Voxels Within a Tumor With Increased or Decreased Signal Intensity (Parametric Response Map Signal Intensity; PRMSI) | Parametric response map analysis using a software calculates the interval change of signal intensity based on a voxel-to-voxel comparison between measurements at baseline and after the first cycle of chemotherapy. PRMSI+ indicates proportions of voxels within a tumor with increased signal intensity. PRMSI- indicates proportions of voxels within a tumor with decreased signal intensity. PRMSI0 indicates proportions of voxels within a tumor with unchanged signal intensity. | Baseline, post-1st chemotherapy |
| Constant for the Transfer of the Contrast Agent From the Plasma Compartment Into the Extracellular Extravascular Space (Ktrans) | Baseline, post-1st chemotherapy |
| Rate Constant of the Escape of the Contrast Agent From the Extracellular Extravascular Space Into the Plasma Compartment (Kep) | Baseline, post-1st chemotherapy |
| Extracellular Extravascular Space Per Unit Volume of Tissue (Ve) | Baseline, post-1st chemotherapy |
| Total Choline Amount of the Tumor Measured on Single Voxel 1H-magnetic Resonance Spectroscopy | Single voxel 1H-magnetic resonance spectroscopy quantifies the amount of total choline-containing compounds of a tumor, which indicates cellular proliferation and malignant transformation. | Baseline, post-1st chemotherapy |
| Standardized Uptake Value on 18F-fluoro-deoxy-glucose Positron Emission Tomography | Baseline, post-1st chemotherapy |
| BG002 | Total | Total of all reporting groups |
| participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Clinical stage (American Joint Committee on Cancer 7th edition) | Number | participants |
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| Estrogen receptor | Number | participants |
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| Progesterone receptor | Number | participants |
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| HER2 | Number | participants |
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| Ki-67 (Cellular marker for proliferation) | Number | participants |
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| Immunohistochemical subtype | Number | participants |
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| Secondary | Tumor Size | Maximal tumor diameter measured on magnetic resonance imaging | Posted | Mean | Standard Deviation | cm | baseline, completion of 1st cycle of chemotherapy |
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| Secondary | Tumor Volume | Tumor volume measured on 3-dimensional magnetic resonance imaging | Posted | Mean | Standard Deviation | cm3 | Baseline, post-1st chemotherapy |
|
|
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| Secondary | Proportions of Voxels Within a Tumor With Increased or Decreased Signal Intensity (Parametric Response Map Signal Intensity; PRMSI) | Parametric response map analysis using a software calculates the interval change of signal intensity based on a voxel-to-voxel comparison between measurements at baseline and after the first cycle of chemotherapy. PRMSI+ indicates proportions of voxels within a tumor with increased signal intensity. PRMSI- indicates proportions of voxels within a tumor with decreased signal intensity. PRMSI0 indicates proportions of voxels within a tumor with unchanged signal intensity. | Posted | Mean | Standard Deviation | % of voxels | Baseline, post-1st chemotherapy |
|
|
|
| Secondary | Constant for the Transfer of the Contrast Agent From the Plasma Compartment Into the Extracellular Extravascular Space (Ktrans) | Posted | Mean | Standard Deviation | min-1 | Baseline, post-1st chemotherapy |
|
|
|
| Secondary | Rate Constant of the Escape of the Contrast Agent From the Extracellular Extravascular Space Into the Plasma Compartment (Kep) | Posted | Mean | Standard Deviation | min-1 | Baseline, post-1st chemotherapy |
|
|
|
| Secondary | Extracellular Extravascular Space Per Unit Volume of Tissue (Ve) | Posted | Mean | Standard Deviation | unitless | Baseline, post-1st chemotherapy |
|
|
|
| Secondary | Total Choline Amount of the Tumor Measured on Single Voxel 1H-magnetic Resonance Spectroscopy | Single voxel 1H-magnetic resonance spectroscopy quantifies the amount of total choline-containing compounds of a tumor, which indicates cellular proliferation and malignant transformation. | Of the 48 participants, 13 participants did not undergo magnetic resonance spectroscopy examinations due to workflow problem. We included the available data from 35 participants. | Posted | Mean | Standard Deviation | unitless | Baseline, post-1st chemotherapy |
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|
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| Secondary | Standardized Uptake Value on 18F-fluoro-deoxy-glucose Positron Emission Tomography | Posted | Mean | Standard Deviation | unitless | Baseline, post-1st chemotherapy |
|
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| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Non-pCR | the presence of invasive tumor cells after surgery | 0 | 42 | 0 | 42 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| PRMSI0 |
|