Preoperative Breast Magnetic Resonance Imaging for Patients Undergoing Mammoplasty

The Role of Preoperative Breast Magnetic Resonance Imaging for Surgical Decision in Patients Undergoing Therapeutic Mammoplasty

all female with operable breast cancer seeking health care at general surgery department Assiut university hospitals,and decision of therapeutic mammoplasty was taken depending on clinical examination, findings on mammography and sonography, will undergo MRI breast, and see if MRI finding will change decision of the surgery.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: magnetic resonance imaging of breast

Detailed Description

• Study Setting: Assiut university hospital, general surgery department (C unit )
• Study subjects: all female with operable breast cancer seeking health care at general surgery department and decision of therapeutic mammoplasty was taken depending on clinical examination, findings on mammography and sonography.

The size, number, and location of breast cancer lesions were identified on US and mammography.

Also size, number, location, pattern of enhancement and presence or absence of intraductal component will be evaluated by preoperative MRI.

The surgical plane will be decided based on US and mammography findings. The final decision will be based on MRI findings. When the initial surgical decision was the same as final decision the patient will be assigned to the unchanged group.

However, if the final decision differed from the initial surgical decision the patient will be assigned to the changed group.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Assiut university hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

All female with operable breast cancer who candidate fot therapeutic mammoplasty,Sample size was calculated using G power, it is 40 patients.

Description

Inclusion Criteria:

• Female patient with operable breast cancer (stage 1 and 2 ) Patient meet the criteria of therapeutic mammoplasty

Exclusion Criteria:

• Inoperable breast cancer (stage 3 and 4) Breast cancer size > 4 cm in diameter Previous radiotherapy Local recurrence after previous breast conservation surgery Male breast cancer

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
percentage of patients whom MRI finding that will change the decision of surgery	1 year

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2017
• Primary Completion (Actual): June 15, 2018
• Study Completion (Actual): August 15, 2018

Study Registration Dates

• First Submitted: May 30, 2017
• First Submitted That Met QC Criteria: May 30, 2017
• First Posted (Actual): June 1, 2017

Study Record Updates

• Last Update Posted (Actual): June 25, 2019
• Last Update Submitted That Met QC Criteria: June 23, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: MRIbreast

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No