Supine MRI in Breast Cancer Patients Undergoing Upfront Surgery or Receiving Neoadjuvant Therapy

Dana-Farber Cancer Institute

Status

Completed

Conditions

Breast Cancer

Treatments

Procedure: Standard of Care

Device: Supine MRI

Other: Neoadjuvant Therapy (NAT)

Device: Standard MRI

Device: Ultrasound

Device: Mammography

Study type

Interventional

Funder types

Other

Identifiers

NCT02956473

16-277

Details and patient eligibility

About

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).

Full 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

Enrollment

57 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

57 participants in 1 patient group

Supine MRI

Experimental group

Description:

* 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