Breast Cancer
Conditions
Keywords
Breast Cancer
Brief summary
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).
Detailed description
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
Interventions
DEVICESupine MRI
OTHERNeoadjuvant Therapy (NAT)
DEVICEUltrasound
DEVICEMammography
PROCEDUREStandard of Care
DEVICEStandard MRI
Sponsors
Dana-Farber Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must be female * Participants must have a pre-operative standard mammogram with or without ultrasound. * Participants must have biopsy confirmed and clinical stage I, stage II, or stage III non-inflammatory breast carcinoma. If biopsy was done at an outside hospital, pathology will be reviewed at (BWH, BWFH) * Patient must meet standard MRI guidelines and be able and willing to undergo MRI * Participants must be candidates for definitive local therapy with breast conserving therapy or deemed as potential candidates following NAT (this takes into account tumor to breast size ratio appropriate for BCT, and the ability to undergo standard radiation therapy post-operatively). * Study participants will be restricted to those aged ≥18 years old. This age group is selected because it encompasses the majority of women likely to receive neoadjuvant therapy * Ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
* Participants with a known BRCA 1 or 2 mutation. * Participants with a known Li-Fraumeni or Cowden's Disease. * Participants with prior mantle radiation. * Participants with inflammatory breast cancer or multi-centric disease * Participants who are pregnant. * Participants who are already enrolled in a conflicting investigational trial * Participants with known active collagen vascular disease. * Participants with prior history of ipsilateral breast carcinoma treated with BCS and radiation therapy. * Patients who have biopsy confirmed multi-centric disease. * Participants who are unable to undergo MRI because of documented contra-indications for contrast-enhanced MRI, including but not limited to renal failure * Participants who exceed the weight limit for the operative surgical table, 350 lbs or who will not fit into the 60 cm diameter bore of the MRI scanner.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between Prone Breast MRI for Estimation of Tumor Size and Final Pathology Tumor Size | time between MRI date (when prone imaging measurements were obtained) and surgery date; median 25.5 days (range 11-40days) | 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. |
| Correlation Between Supine Breast MRI for Estimation Of Tumor Size and The Pathologic Tumor Size | time between supine breast MRI imaging and surgery; median 25.5 days, range 11-40 days | 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.. |
| Correlation of Breast Tumor Dimensions Between Prone and Supine Imaging Positions. | at time of MRI imaging | Correlate maximal tumor Dimensions as measured by the radiologist between the Prone and Supine MRI Images |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | after surgery | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Supine MRI * Standard MRI will be performed
* Supine MRI will be performed
* Participant will receive mammography and ultrasound
* Breast Radiologist will take a brief survey.
* Patients will undergo upfront surgery or receive Neoadjuvant Therapy per standard of care
* Standard of care will be performed
Supine MRI
Neoadjuvant Therapy (NAT)
Ultrasound
Mammography
Standard of Care
Standard MRI | 57 |
| Total | 57 |
Baseline characteristics
| Characteristic | Supine MRI |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 48 Participants |
| Age, Continuous | 52 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 48 Participants |
| Region of Enrollment United States | 57 Participants |
| Sex: Female, Male Female | 57 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
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.
Time frame: time between MRI date (when prone imaging measurements were obtained) and surgery date; median 25.5 days (range 11-40days)
Population: Analysis performed of 38 patients with Prone MRI imaging measurements and surgical pathology measurements
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard (Prone) MRI Tumor Imaging | Correlation Between Prone Breast MRI for Estimation of Tumor Size and Final Pathology Tumor Size | 0.635 correlation coefficient |
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..
Time frame: time between supine breast MRI imaging and surgery; median 25.5 days, range 11-40 days
Population: We analyzed MRI tumor size and pathologic tumor size for 26 pts with both supine MRI measurements and final pathology measurements
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard (Prone) MRI Tumor Imaging | Correlation Between Supine Breast MRI for Estimation Of Tumor Size and The Pathologic Tumor Size | 0.652 correlation coefficient |
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
Time frame: at time of MRI imaging
Population: 40 pts who had both a prone and a supine MRI measurement of tumor size
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard (Prone) MRI Tumor Imaging | Correlation of Breast Tumor Dimensions Between Prone and Supine Imaging Positions. | 0.789 correlation coefficient |
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.
Time frame: after surgery
Population: among 30 pts analyzed, 13 surgeons reported the supine imaging was helpful whereas 17 surgeons reported the imaging was not helpful
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard (Prone) MRI Tumor Imaging | 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 | 0.43 proportion of participants |