Supine MRI in Breast Cancer Patients Receiving Neoadjuvant Therapy

NOT ENROLLING
Protocol # :
16-277
Conditions
Breast Cancer
Phase
Not Applicable
Disease Sites
Breast
Principal Investigator
King, Tari

Trial Description

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).

Eligibility Requirements

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.

16-277