Diffusion Tensor Breast MRI (DTI)

NCT ID: NCT02812589

Last Updated: 2021-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 267 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2020-04-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diffusion tensor imaging (DTI) in breast MRI

Group Type: EXPERIMENTAL

Diffusion tensor imaging (DTI) in Breast MRI

Intervention Type: OTHER

Interventions

Diffusion tensor imaging (DTI) in Breast MRI

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anabel Scaranelo, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

Princess Margaret Cancer Centre, University Health Network, 610 University Ave.

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

13-6856-CE

Identifier Type: -

Identifier Source: org_study_id