Diffusion Tensor Breast MRI (DTI)

NCT02812589 | Completed

• 1 other identifier: 13-6856-CE
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 1

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

Keywords

MRI

Outcome Measures

Primary Outcomes (1)

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

  3 years

Study Arms (1)

Diffusion tensor imaging (DTI) in breast MRI

EXPERIMENTAL

Other: Diffusion tensor imaging (DTI) in Breast MRI

Interventions

Diffusion tensor imaging (DTI) in Breast MRI OTHER

Diffusion tensor imaging (DTI) in breast MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

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

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Diffusion Tensor Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Anabel Scaranelo, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2016
• First Posted: June 24, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: April 13, 2021

Record last verified: 2021-04

Locations

CA (1)