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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00948285
Recruitment Status : Recruiting
First Posted : July 29, 2009
Last Update Posted : January 8, 2019
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: MRI Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Breast Cancer Staging MAgnetic Resonance for Treatment (B-SMART)
Study Start Date : July 2009
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. A difference of 10% in the margin revision rate in women undergoing breast conservation for cancer. [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00948285

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Contact: Rakhshanda L Rahman, MD 806-354-5543
Contact: Nancy Rudolph, RN 806-354-5543

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United States, Texas
Texas Tech University Health Sciences Center School of Medicine Recruiting
Amarillo, Texas, United States, 79106
Contact: Rakhshanda L Rahman, MD    806-354-5543   
Contact: Nancy Rudolph, RN    806-354-5543   
Principal Investigator: Rakhshanda L Rahman, MD         
Sub-Investigator: Mark Arredondo, MD         
Principal Investigator: Sharmila Dissanaike, MD         
Principal Investigator: Robert Quinlan, MD         
Sub-Investigator: Anne Larkin, MD         
Sub-Investigator: Nilima Patwardhan, MD         
Sub-Investigator: Sonia Ortiz-Pagan, MD         
Sponsors and Collaborators
Texas Tech University Health Sciences Center
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Principal Investigator: Rakhshanda L Rahman, MD Texas Tech University Health Sciences Center

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Responsible Party: Texas Tech University Health Sciences Center Identifier: NCT00948285     History of Changes
Other Study ID Numbers: A09-3519
First Posted: July 29, 2009    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Keywords provided by Texas Tech University Health Sciences Center:
breast cancer
magnetic resonance imaging
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases