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Diffusion Tensor Breast MRI (DTI)

University Health Network, Toronto logo

University Health Network, Toronto

Status

Completed

Conditions

Breast Cancer

Treatments

Other: Diffusion tensor imaging (DTI) in Breast MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT02812589
13-6856-CE

Details and patient eligibility

About

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.

Enrollment

267 patients

Sex

Female

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

267 participants in 1 patient group

Diffusion tensor imaging (DTI) in breast MRI
Experimental group
Treatment:
Other: Diffusion tensor imaging (DTI) in Breast MRI

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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