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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diffusion tensor imaging (DTI) in Breast MRI

Other

Primary outcomes

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

Time frame: 3 years

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2020
Study completion: 2020
First posted: Jun 24, 2016
Registry last updated: Apr 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed