Diffusion Tensor Breast MRI (DTI)

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02812589
• Other study ID #: 13-6856-CE
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: April 2020

Study information

• Verified date: April 2021
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre, University Health Network, 610 University Ave.	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validate DTI as a valuable adjunct to improve lesion characterization on breast MRI by using the difference in recall rates		3 years