Diffusion Tensor Breast MRI (DTI)

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Other: Diffusion tensor imaging (DTI) in Breast MRI

• Registration Number: NCT02812589
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-05-04
• Study First Submitted QC: 2016-06-23
• Study First Posted: 2016-06-24
• Primary Completion: 2020-04
• Study Completion: 2020-04
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-11
• Last Update Posted: 2021-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 267

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diffusion tensor imaging (DTI) in breast MRI	Diffusion tensor imaging (DTI) in Breast MRI	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Princess Margaret Cancer Centre, University Health Network, 610 University Ave.; 🇨🇦 Toronto, Ontario, Canada