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technical difficulties for scans on the research MRI system
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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Neoadjuvant chemotherapy (NACT) is administered to treat invasive breast cancer before surgery. It offers the opportunity to evaluate tumor response to treatment in aggressive disease, and guide additional therapies for patients with inadequate response, if detected early. Investigators propose to develop a sodium breast MRI technique that will allow to assess the early metabolic response of breast cancer to NACT, occurring before late structural changes can be detected with standard MRI.
This study will scan 12 patients using 1H/23Na MRI at 7 T and DCE MRI with triple-negative breast cancer undergoing AC-T therapy (2 months of Adriamycin + Cyclophosphamide, then 3 months of Taxol): at baseline (pre-NACT); after the first AC cycle (2 weeks); after AC treatment (2 months); after complete NACT (5 months, pre-surgery).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triple Negative Breast Cancer Patients | Experimental | scanned 4 times to assess breast cancer response to NACT with the proposed method. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium (Na) Magnetic Resonance Imaging (MRI) | Diagnostic Test | Two Na data will be acquired:
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Tumor Size | Dynamic contrast-enhanced MRI will be used to measure tumor size before and after treatment. | Baseline, 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Total Sodium Concentration (TSC) | TSC was directly measured from 23Na images using a phantom calibration | Baseline |
| Intracellular Sodium Concentration (CIC) | CIC is derived from this equation: TSC = ECV · CEC + ICV · CIC + (1 -WF) · Cfat |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillaume Madelin, PhD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Triple Negative Breast Cancer Patients | scanned 4 times to assess breast cancer response to NACT with the proposed method. Sodium (Na) Magnetic Resonance Imaging (MRI): Two Na data will be acquired:
Dynamic Contrast- Enhanced (DCE) MRI: DCE MRI will be acquired subsequent to Na MRI to prevent influence of the contrast agent on 23 Na data |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Triple Negative Breast Cancer Patients | scanned 4 times to assess breast cancer response to NACT with the proposed method. Sodium (Na) Magnetic Resonance Imaging (MRI): Two Na data will be acquired:
Dynamic Contrast- Enhanced (DCE) MRI: DCE MRI will be acquired subsequent to Na MRI to prevent influence of the contrast agent on 23 Na data |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Tumor Size | Dynamic contrast-enhanced MRI will be used to measure tumor size before and after treatment. | The study was terminated due to technical difficulties; therefore, no follow-ups during or after therapy were performed with only scans at baseline | Posted | Baseline, 2 Years |
|
2 years
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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 | Triple Negative Breast Cancer Patients | scanned 4 times to assess breast cancer response to NACT with the proposed method. Sodium (Na) Magnetic Resonance Imaging (MRI): Two Na data will be acquired:
Dynamic Contrast- Enhanced (DCE) MRI: DCE MRI will be acquired subsequent to Na MRI to prevent influence of the contrast agent on 23 Na data |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Guillaume Madelin, PhD | NYU Langone Health | (212) 263-3343 | guillaume.madelin@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 2, 2020 | Aug 1, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Dynamic Contrast- Enhanced (DCE) MRI | Diagnostic Test | DCE MRI will be acquired subsequent to Na MRI to prevent influence of the contrast agent on 23 Na data |
|
| Baseline |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
| Secondary | Total Sodium Concentration (TSC) | TSC was directly measured from 23Na images using a phantom calibration | Posted | Mean | Standard Deviation | mM | Baseline |
|
|
|
| Secondary | Intracellular Sodium Concentration (CIC) | CIC is derived from this equation: TSC = ECV · CEC + ICV · CIC + (1 -WF) · Cfat | Posted | Mean | Standard Deviation | mM | Baseline |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
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| D017437 |
| Skin and Connective Tissue Diseases |