Back to results

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

Primary Purpose

Breast Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Supine MRI

Neoadjuvant Therapy (NAT)

Ultrasound

Mammography

Standard of Care

Standard MRI

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

Brigham and Women's Hospital
Dana Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supine MRI

Arm 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

Outcomes

Primary Outcome Measures

Evaluate The Correlation Between Prone Breast MRI in Estimating Tumor Size at upfront surgery or post-NAT and Pathologic Results, and The Correlation Between Supine Breast MRI And Pathologic Results.

Compare The Correlation Between Supine Breast MRI for Estimation Of Tumor Size at upfront surgery or post-NAT and The Pathologic Residual Tumor Size, and The Correlation Between Existing Breast Imaging Modalities And The Pathologic Residual Tumor Size.

Characterize The Changes Occurring In Breast Tumor-Associated Properties/ Dimensions Between The Prone And Supine Imaging Position And To Determine The Correlation Of Tumor Location And Geometry On supine MRI with prone MRI

Secondary Outcome Measures

Assess The Value Of Supine MRI For Radiologists Performing Second Look US Examinations/ Biopsies Following Identification Of New Lesions on MRI, And Performing Preoperative Lesion Localization Using Supine MRI Guidance

Assess 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

Explore The Effect Of Supine MRI On Influencing Breast-conserving Surgery (BCS) Outcomes

Assess The Perceived Value Of Supine MRI For Adjuvant Radiation Breast Treatment Planning

Full Information

NCT ID

NCT02956473

First Posted

November 3, 2016

Last Updated

August 30, 2023

Sponsor

Dana-Farber Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT02956473

Brief Title

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

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

November 15, 2016 (Actual)

Primary Completion Date

August 2022 (Actual)

Study Completion Date

August 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dana-Farber Cancer Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Breast Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

57 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Supine MRI

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Supine MRI

Intervention Type

Other

Intervention Name(s)

Neoadjuvant Therapy (NAT)

Intervention Type

Device

Intervention Name(s)

Ultrasound

Intervention Type

Device

Intervention Name(s)

Mammography

Intervention Type

Procedure

Intervention Name(s)

Standard of Care

Intervention Type

Device

Intervention Name(s)

Standard MRI

Primary Outcome Measure Information:

Title

Evaluate The Correlation Between Prone Breast MRI in Estimating Tumor Size at upfront surgery or post-NAT and Pathologic Results, and The Correlation Between Supine Breast MRI And Pathologic Results.

Time Frame

2 years

Title

Time Frame

2 Years

Title

Time Frame

2years

Secondary Outcome Measure Information:

Title

Time Frame

2 years

Title

Time Frame

2 years

Title

Explore The Effect Of Supine MRI On Influencing Breast-conserving Surgery (BCS) Outcomes

Time Frame

2 years

Title

Assess The Perceived Value Of Supine MRI For Adjuvant Radiation Breast Treatment Planning

Time Frame

2 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tari King, MD

Organizational Affiliation

Brigham and Women's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brigham and Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs