Diffusion Tensor Breast MRI (DTI)

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02812589

Enrollment

267

Registered

2016-06-24

Start date

2016-04-30

Completion date

2020-04-30

Last updated

2021-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

MRI

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.

Interventions

OTHERDiffusion tensor imaging (DTI) in Breast MRI

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026