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Importance of Magnetic Resonance Imaging (MRI) in Treating Breast Cancer (BSMART)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT00948285
First received: July 27, 2009
Last updated: January 3, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Breast Cancer
Procedure: MRI

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Breast Cancer Staging MAgnetic Resonance for Treatment (B-SMART)

Resource links provided by NLM:


Further study details as provided by Texas Tech University Health Sciences Center:

Primary Outcome Measures:
  • A difference of 10% in the margin revision rate in women undergoing breast conservation for cancer. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: July 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MRI
Preoperative staging with mammogram, ultrasound, and MRI, followed by surgery (n=200)
Procedure: MRI
magnetic resonance imaging (MRI)
No Intervention: Non-MRI
Preoperative staging with mammogram and ultrasound alone, followed by surgery (n=200)

Detailed Description:

We propose that the role of preoperative staging-MRI in breast cancer be studied by following the occurrence of negative margins at first surgery and the volume of resection in a randomized prospective study. The need for re-excision is an objective marker of satisfactory local surgery and is available as soon as the final pathology report is back. We propose that the closest margin and the rate of re-excision be used as the primary outcome measures to evaluate the contribution of MRI. In addition, since cosmetic preservation is one of the goals of breast conservation, we propose that cosmetic outcome be used as the secondary outcome measure. The visual analogue scale for cosmetic outcome varies between observers and with time; however, the volume of tissue that is excised is an objective surrogate of cosmetic outcome.15 Since the excised volume is dictated by the tumor volume, the only variable under the surgeon's control is the volume of benign tissue excised in order to obtain negative margins. Hence, in this study, we propose to use a volume index of excised margins as an outcome measure for cosmesis. The index value will be calculated for each subject by adding the two measurements of benign margin for each of the three dimensions measured and multiplying them to produce a volume index for each subject.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00948285

Locations
United States, Texas
Texas Tech University Health Sciences Center School of Medicine
Amarillo, Texas, United States, 79106
Sponsors and Collaborators
Texas Tech University Health Sciences Center
Investigators
Principal Investigator: Rakhshanda L Rahman, MD Texas Tech University Health Sciences Center
  More Information

No publications provided

Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT00948285     History of Changes
Other Study ID Numbers: A09-3519
Study First Received: July 27, 2009
Last Updated: January 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Tech University Health Sciences Center:
breast cancer
magnetic resonance imaging

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 27, 2014