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

This study is currently recruiting participants.
Verified August 2017 by Texas Tech University Health Sciences Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT00948285
First Posted: July 29, 2009
Last Update Posted: October 11, 2017
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.
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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 ]

Estimated Enrollment: 400
Study Start Date: July 2009
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes 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
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 ClinicalTrials.gov identifier (NCT number): NCT00948285


Contacts
Contact: Rakhshanda L Rahman, MD 806-354-5543 rakhshanda.rahman@ttuhsc.edu
Contact: Nancy Rudolph, RN 806-354-5543 nancy.rudolph@ttuhsc.edu

Locations
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    rakhshanda.rahman@ttuhsc.edu   
Contact: Nancy Rudolph, RN    806-354-5543    nancy.rudolph@ttuhsc.edu   
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
Investigators
Principal Investigator: Rakhshanda L Rahman, MD Texas Tech University Health Sciences Center
  More Information

Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT00948285     History of Changes
Other Study ID Numbers: A09-3519
First Submitted: July 27, 2009
First Posted: July 29, 2009
Last Update Posted: October 11, 2017
Last Verified: August 2017

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

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