Diffusion Tensor Breast MRI (DTI)

Improving the Specificity of Breast MRI Through Diffusion Tensor Breast MRI (DTI)

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Diffusion tensor imaging (DTI) in Breast MRI

• Study Type: Interventional
• Enrollment (Actual): 267
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre, University Health Network, 610 University Ave.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Diffusion tensor imaging (DTI) in breast MRI	Other: Diffusion tensor imaging (DTI) in Breast MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Validate DTI as a valuable adjunct to improve lesion characterization on breast MRI by using the difference in recall rates	3 years

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Anabel Scaranelo, MD, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2016
• Primary Completion (ACTUAL): April 1, 2020
• Study Completion (ACTUAL): April 1, 2020

Study Registration Dates

• First Submitted: May 4, 2016
• First Submitted That Met QC Criteria: June 23, 2016
• First Posted (ESTIMATE): June 24, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 13, 2021
• Last Update Submitted That Met QC Criteria: April 11, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: MRI
• Other Study ID Numbers: 13-6856-CE