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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

Tracking Information
First Submitted Date  ICMJE May 4, 2016
First Posted Date  ICMJE June 24, 2016
Last Update Posted Date May 7, 2019
Actual Study Start Date  ICMJE April 2016
Actual Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2016)
Validate DTI as a valuable adjunct to improve lesion characterization on breast MRI by using the difference in recall rates [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diffusion Tensor Breast MRI (DTI)
Official Title  ICMJE Improving the Specificity of Breast MRI Through Diffusion Tensor Breast MRI (DTI)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Breast Cancer
Intervention  ICMJE Other: Diffusion tensor imaging (DTI) in Breast MRI
Study Arms  ICMJE Experimental: Diffusion tensor imaging (DTI) in breast MRI
Intervention: Other: Diffusion tensor imaging (DTI) in Breast MRI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 3, 2019)
267
Original Estimated Enrollment  ICMJE
 (submitted: June 23, 2016)
300
Estimated Study Completion Date  ICMJE April 2020
Actual Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02812589
Other Study ID Numbers  ICMJE 13-6856-CE
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anabel Scaranelo, MD University Health Network, Toronto
PRS Account University Health Network, Toronto
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP