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

NCT02956473 | Completed Results DMC

• 1 other identifier: 16-277
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 2

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).

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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)

• 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

• 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 Outcomes (1)

• 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

  after surgery

Study Arms (1)

Supine MRI

EXPERIMENTAL

* 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

Device: Supine MRI; Other: Neoadjuvant Therapy (NAT); Device: Ultrasound; Device: Mammography; Procedure: Standard of Care; Device: Standard MRI

Interventions

Supine MRI DEVICE

Supine MRI

Neoadjuvant Therapy (NAT) OTHER

Supine MRI

Ultrasound DEVICE

Supine MRI

Mammography DEVICE

Supine MRI

Standard of Care PROCEDURE

Supine MRI

Standard MRI DEVICE

Supine MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Neoadjuvant Therapy; Ultrasonography; Mammography; Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr. Tari King
• Organization: Dana-Farber/Brigham Cancer Center

tking7@bwh.harvard.edu

617-582-8292

Study Officials

• Tari King, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 7, 2016
• Study Start: November 15, 2016
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: March 12, 2024
• Results First Posted: March 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)