Clinical trial NCT02956473: Supine MRI in Breast Cancer Patients Undergoing Upfront Surgery or Receiving Neoadjuvant Therapy
Official title: Supine MRI in Breast Cancer Patients Undergoing Upfront Surgery or Receiving Neoadjuvant Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2016-11-06
Enrollment: 57
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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.

Primary outcomes:
measure: Correlation Between Prone Breast MRI for Estimation of Tumor Size and Final Pathology Tumor Size
timeFrame: time between MRI date (when prone imaging measurements were obtained) and surgery date; median 25.5 days (range 11-40days)
measure: Correlation Between Supine Breast MRI for Estimation Of Tumor Size and The Pathologic Tumor Size
timeFrame: time between supine breast MRI imaging and surgery; median 25.5 days, range 11-40 days
measure: Correlation of Breast Tumor Dimensions Between Prone and Supine Imaging Positions.
timeFrame: at time of MRI imaging
Secondary outcomes:
measure: 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
timeFrame: after surgery
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Tari King, MD
role: PRINCIPAL_INVESTIGATOR
References: