NCT00948285

Brief Summary

The purpose of this study is to determine if the use of magnetic resonance imaging (MRI) for breast cancer translates into better surgical outcomes. MRIs may help ensure that as little healthy tissue is removed as is possible and may help prevent the need for additional surgical procedures.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
194

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Jul 2009

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2009

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

November 13, 2019

Status Verified

November 1, 2019

Enrollment Period

9.2 years

First QC Date

July 27, 2009

Last Update Submit

November 11, 2019

Conditions

Breast Cancer

Keywords

breast cancermagnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

  • A difference of 10% in the margin revision rate in women undergoing breast conservation for cancer.

    3 years

Study Arms (2)

MRI

EXPERIMENTAL

Preoperative staging with mammogram, ultrasound, and MRI, followed by surgery (n=200)

Procedure: MRI

Non-MRI

NO INTERVENTION

Preoperative staging with mammogram and ultrasound alone, followed by surgery (n=200)

Interventions

MRIPROCEDURE

magnetic resonance imaging (MRI)

MRI

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly diagnosed breast cancer patients
  • Breast cancer patients identified as conservation candidates by their surgeons

You may not qualify if:

  • Patients with a history of prior breast cancer treatment (recurrence)
  • Patients with breast cancer diagnosis during pregnancy (women who could bear children must have a negative pregnancy test before beginning this study)
  • Patients with documented sensitivity to gadolinium (contrast agent used during MRI)
  • Patients who weigh more than 350 pounds (weight limit on MRI machine)
  • Patients who receive neoadjuvant chemotherapy
  • Patients with renal insufficiency (serum Cr \> 1.5) due to the danger of nephrogenic systemic sclerosis with the administration of Gadolinium

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Tech University Health Sciences Center School of Medicine

Amarillo, Texas, 79106, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Rakhshanda L Rahman, MD

    Texas Tech University Health Sciences Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2009

First Posted

July 29, 2009

Study Start

July 1, 2009

Primary Completion

September 1, 2018

Study Completion

December 1, 2018

Last Updated

November 13, 2019

Record last verified: 2019-11

Locations

US(1)