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This research study involves the use of a common breast imaging modality (magnetic resonance imaging, 'MRI') and is investigating its role in evaluating surgical decision making for breast cancer when it is performed with the patient in a new position (lying on one's back) as opposed to in the standard position (lying on one's stomach).
The procedure involved is called a supine breast magnetic resonance imaging (MRI).In this study, the investigators are evaluating the value of supine MRI in surgical decision making for women with breast cancer either undergoing upfront surgery or for those anticipating surgery after receiving neoadjuvant therapy.
The purpose of this study is to assess the value of supine breast MRI as a new imaging method to assist in surgical treatment planning. It is possible that the use of supine breast MRI will help your doctor see the size and location of tumors more accurately
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supine MRI | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supine MRI | Device |
| ||
| Neoadjuvant Therapy (NAT) |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between Prone Breast MRI for Estimation of Tumor Size and Final Pathology Tumor Size | Comparing tumor size as measured on prone MRI images with tumor size as measured on final pathology among pts undergoing upfront surgery and among pts undergoing neoadjuvant chemotherapy. In the neoadjuvant chemotherapy group the post-treatment MRI images were used. | time between MRI date (when prone imaging measurements were obtained) and surgery date; median 25.5 days (range 11-40days) |
| Correlation Between Supine Breast MRI for Estimation Of Tumor Size and The Pathologic Tumor Size | Compared tumor size as reported by radiologist on the clinical report between Supine Breast MRI and The Pathologic Residual Tumor Size as reported by the pathologist on the final surgical pathology report.. | time between supine breast MRI imaging and surgery; median 25.5 days, range 11-40 days |
| Correlation of Breast Tumor Dimensions Between Prone and Supine Imaging Positions. | Correlate maximal tumor Dimensions as measured by the radiologist between the Prone and Supine MRI Images | at time of MRI imaging |
| Measure | Description | Time Frame |
|---|---|---|
| The Perceived Benefit Of Supine MRI For Surgical Planning As Measured By The Collective Results Of A Survey Of Surgeons Performing Breast-conserving Therapy (BCT) In Our Study Patient Population | Reported as the proportion of surgeons answering yes. Surgeon reported answers to surveys asking if the supine MRI helped in the performance of the surgical procedure. | after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tari King, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States | ||
| Dana Farber Cancer Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | Supine MRI |
Supine MRI Neoadjuvant Therapy (NAT) Ultrasound Mammography Standard of Care Standard MRI |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Supine MRI |
Supine MRI Neoadjuvant Therapy (NAT) Ultrasound Mammography Standard of Care Standard MRI |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Correlation Between Prone Breast MRI for Estimation of Tumor Size and Final Pathology Tumor Size | Comparing tumor size as measured on prone MRI images with tumor size as measured on final pathology among pts undergoing upfront surgery and among pts undergoing neoadjuvant chemotherapy. In the neoadjuvant chemotherapy group the post-treatment MRI images were used. | Analysis performed of 38 patients with Prone MRI imaging measurements and surgical pathology measurements | Posted | Number | 95% Confidence Interval | correlation coefficient | time between MRI date (when prone imaging measurements were obtained) and surgery date; median 25.5 days (range 11-40days) |
|
1 month
The definition does not differ from the clinicaltirals.gov definitions.
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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 | Supine MRI |
Supine MRI Neoadjuvant Therapy (NAT) Ultrasound Mammography Standard of Care Standard MRI |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tari King | Dana-Farber/Brigham Cancer Center | 617-582-8292 | tking7@bwh.harvard.edu |
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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 8, 2022 | Oct 12, 2023 | Prot_SAP_000.pdf |
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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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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| D014463 | Ultrasonography |
| D008327 | Mammography |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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|
| Ultrasound | Device |
|
| Mammography | Device |
|
| Standard of Care | Procedure |
|
| Standard MRI | Device |
|
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Correlation Between Supine Breast MRI for Estimation Of Tumor Size and The Pathologic Tumor Size | Compared tumor size as reported by radiologist on the clinical report between Supine Breast MRI and The Pathologic Residual Tumor Size as reported by the pathologist on the final surgical pathology report.. | We analyzed MRI tumor size and pathologic tumor size for 26 pts with both supine MRI measurements and final pathology measurements | Posted | Number | 95% Confidence Interval | correlation coefficient | time between supine breast MRI imaging and surgery; median 25.5 days, range 11-40 days |
|
|
|
| Primary | Correlation of Breast Tumor Dimensions Between Prone and Supine Imaging Positions. | Correlate maximal tumor Dimensions as measured by the radiologist between the Prone and Supine MRI Images | 40 pts who had both a prone and a supine MRI measurement of tumor size | Posted | Number | 95% Confidence Interval | correlation coefficient | at time of MRI imaging |
|
|
|
| Secondary | The Perceived Benefit Of Supine MRI For Surgical Planning As Measured By The Collective Results Of A Survey Of Surgeons Performing Breast-conserving Therapy (BCT) In Our Study Patient Population | Reported as the proportion of surgeons answering yes. Surgeon reported answers to surveys asking if the supine MRI helped in the performance of the surgical procedure. | among 30 pts analyzed, 13 surgeons reported the supine imaging was helpful whereas 17 surgeons reported the imaging was not helpful | Posted | Number | 95% Confidence Interval | proportion of participants | after surgery |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D003933 | Diagnosis |
| D011859 | Radiography |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |