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Clinical Trial ACRINBRE6702

Title

A Multi-Center Study Evaluating the Utility of Diffusion Weighted Imaging for Detection and Diagnosis of Breast Cancer

Principal Investigator(s)

Sara Harvey

Details

  • Protocol No. ACRINBRE6702
  • Open Date: 06/11/2014
  • Staging: N/A
  • Age Group: Adults
  • Scope: National
  • Objective: To determine whether the Apparent Diffusion Coefficient (ADC), when used systematically in conjunction with conventional DCE-MRI, can reduce the biopsy rate by at least 20% while maintaining sensitivity.
  • Disease Sites: Breast
  • Therapies: None Specified
  • Drugs: None Specified
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT02022579
  • Secondary Protocol No: ACRIN 6702

Description

None Provided.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Female
Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria:
• Willing and able to provide written informed consent;
• 18 years of age or older;
• Successful completion of breast MR examination with DWI required by protocol;
• Undiagnosed breast lesion (BI-RADS 3, 4, or 5) identified on MRI. The BI-RADS assessment must refer to a focal finding within the breast (i.e. mass, non-mass, or focus) as opposed to diffuse processes (e.g. background parenchymal enhancement, skin thickening) or lesions outside the subcutaneous breast (e.g. axillary lymph nodes, focal skin lesions, osseous lesions, etc.).
Exclusion Criteria:
• Participants with current or recent history (within 6 months prior to the MRI) of chemotherapy for cancer;
• Neoadjuvant chemotherapy between MRI and confirmation of lesion outcome (study lesions must be biopsied prior to undergoing any chemotherapy);
• Pregnant (if a female is of childbearing potential•defined as a pre-menopausal female capable of becoming pregnant•confirmation of pregnancy status per the site's standard of practice should be done prior to MRI);
• Unwilling or not suitable to undergo MRI or use the contrast agent gadolinium.