Supine MRI in Breast Cancer Patients Receiving Neoadjuvant Therapy



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 70
Updated:11/14/2018
Start Date:November 15, 2016
End Date:December 2021
Contact:Mehra Golshan, MD
Email:mgolshan@partners.org
Phone:617-632-2174

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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 treatment 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 the treatment of women
with breast cancer before and after receiving neoadjuvant therapy.

The purpose of this study is to assess the value of supine breast MRI as a new imaging method
for women receiving neoadjuvant therapy. It is possible that the use of supine breast MRI
will help your doctor see the size and location of tumors more accurately

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 neoadjuvant therapy (NAT) upfront

- 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 and <70 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.
We found this trial at
2
sites
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Mehra Golshan, MD
Phone: 617-632-2174
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Mehra Golshan, MD
Phone: 617-632-2174
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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