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Diffusion Tensor Breast MRI (DTI)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02812589
Recruitment Status : Active, not recruiting
First Posted : June 24, 2016
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
The breast MRI is used in the preoperative scenario to evaluate the extension of a newly diagnosed breast cancer and to screen the contralateral breast. The scan consists of a series of images taken after the use of intravascular contrast media that may detect areas of enhancement that look malignant, but are actually benign tissue, producing a false positive result. The investigators aim to evaluate a novel MRI sequence of images that does not use contrast, diffusion tensor imaging (DTI). Addition of DTI sequence does not add significantly to the time of standard breast MRI exam. This novel technique provides improved detection of tissue microstructure and is able to differentiate malignant from benign tumor. Hence, the investigators hypothesize that DTI may decrease the false positive rate when compared with standard dynamic contrast-enhanced (DCE) MRI.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: Diffusion tensor imaging (DTI) in Breast MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 267 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Improving the Specificity of Breast MRI Through Diffusion Tensor Breast MRI (DTI)
Actual Study Start Date : April 2016
Actual Primary Completion Date : April 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diffusion tensor imaging (DTI) in breast MRI Other: Diffusion tensor imaging (DTI) in Breast MRI



Primary Outcome Measures :
  1. Validate DTI as a valuable adjunct to improve lesion characterization on breast MRI by using the difference in recall rates [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female of any race, ethnicity and lifetime risk.
  • Eighteen years or older.
  • Known recent diagnosis of a breast cancer and normal clinical breast exam of the contralateral side.
  • Self-detected lump suspicious for breast cancer that it has not been biopsied yet.

Exclusion Criteria:

  • Inability to understand the consent form
  • Pregnant or nursing
  • Currently taking tamoxifen, evista (raloxifene), or an aromatase inhibitor for adjuvant therapy or chemoprevention
  • Physically unable to lie down on her belly for at least 10 minutes.
  • Have had benign needle biopsy of the breast performed within 3 months, or breast surgery within 1 year prior to MRI exam.

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): NCT02812589


Locations
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Canada, Ontario
Princess Margaret Cancer Centre, University Health Network, 610 University Ave.
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Anabel Scaranelo, MD University Health Network, Toronto
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02812589    
Other Study ID Numbers: 13-6856-CE
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Keywords provided by University Health Network, Toronto:
MRI