Use of Breast MRI for Local Staging

Breast Cancer Clinical Trial

Official title:

Use of Breast MRI for Local Staging

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00579319
• Other study ID #: 37639
• Status: Withdrawn
• Phase: N/A
• First received: December 20, 2007
• Last updated: March 3, 2015
• Start date: April 2005
• Est. completion date: April 2009

Study information

• Verified date: March 2015
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

When breast MRI is used to determine the extent of local disease, the management changes, resulting in improved outcomes. Studies have indicated that breast MRI plus mammography is better for detecting tumors. surgeons are now utilizing breast MRI to determine the extent of disease in women diagnosed with breast cancer. It has not been established how management of breast cancer patients has been affected by the use of breast MRI or how that management has affected the outcome for these patients. This retrospective chart review will document management and outcome for breast cancer patients who have had pre treatment breast MRI.

Description:

When breast MRI is used to determine the extent of local disease, the management changes, resulting in improved outcomes. Studies have indicated that breast MRI plus mammography is better for detecting tumors. surgeons are now utilizing breast MRI to determine the extent of disease in women diagnosed with breast cancer. It has not been established how management of breast cancer patients has been affected by the use of breast MRI or how that management has affected the outcome for these patients. This retrospective chart review will document management and outcome for breast cancer patients who have had pre treatment breast MRI.

The medical records of patients who received breast MRI for pre—treatment staging of breast cancer will be retrospectively reviewed to see if the MRI information affected management. UAMS surgeons will be asked if the breast MRI resulted in:

1. no change in management

2. Moderate change in management−what (modified lumpectomy−larger or smaller)

3. Significant change−what (contralateral breast, additional quadrants, lump to mast, neoadjuvant chemo)−note less dz than w/o MRI, more dz than w/o MRI. The medical record of patients who were imaged will be reviewed for presenting symptom, clinical exam, imaging studies (mammogram, breast ultrasound, breast MRi) and pathology results. This study is limited to retrospective chart review with the only foreseeable risk being that of disclosure of PHI. To minimize this risk, data collection forms will be identified by subject ID number. A master list of these ID numbers linked to subject medical record number will be maintained in the investigator's file and kept in a secure location accessible only to the study team for purposes of verification of data and validation of results. The medical record number will not be recorded on any other form containing subject PHI. The only foreseeable breach of confidentiality would be for the security of the investigator's files to be compromised.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Patients who have undergone a breast MRI for staging

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breast Cancer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breast MRI will have a significant impact on patient management		at time of staging	No