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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02956473
• Other study ID #: 16-277
• Status: Completed
• Phase: N/A
• Start date: November 15, 2016
• Est. completion date: August 2022

Study information

• Verified date: February 2024
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Supine MRI

Other:
• Neoadjuvant Therapy (NAT)

Device:
• Ultrasound

• Mammography

Procedure:
• Standard of Care

Device:
• Standard MRI

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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 between MRI date (when prone imaging measurements were obtained) and surgery date; median 25.5 days (range 11-40days)
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 between supine breast MRI imaging and surgery; median 25.5 days, range 11-40 days
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	at time of MRI imaging
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.	after surgery