Magnetic Resonance Imaging of Breast Cancer

Stanford University

Status: Enrolling

Conditions: Breast Cancer Non-invasive Breast Cancer; Breast Cancer

Treatments: Procedure: MRI

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01035112

IRB-10748

CA66785 (Other Identifier)

BRSNSTU0004

75763 (Other Identifier)

13IB-0074 (Other Identifier)

Details and patient eligibility

About

To compare magnetic resonance imaging (MRI) with more well established diagnostic imaging techniques to determine which method best finds and defines breast cancer.

Enrollment: 445 estimated patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

INCLUSION CRITERIA

• Female
• Documented breast physical examination,
• Documented mammography within 3 months of the MR studies
• Palpable or mammographically-detected suspect breast lesions
• Women who have already undergone lumpectomy for breast cancer and have post-biopsy/post-radiation changes will be eligible if they have mammographically-detected or palpable breast abnormalities which are sufficiently suspicious to merit core needle or surgical biopsy.

EXCLUSION CRITERIA:

• Male by birth
• Able to complete the MR examination. Subjects will be interviewed by one of the investigators for the usual contraindications to
• MR contraindications including
• Pacemakers
• Metallic implants
• Severe claustrophobia
• Aneurysm clips
• Pregnancy
• Current lactation
• Other conditions precluding proximity to a strong magnetic field.
• Received an enhanced MR procedure within 48 hours,
• Iodinated contrast within six hours,
• Known sensitivity to MR contrast agents,
• Not likely to complete the study in full or
• Other clinical reason which would preclude participation in the protocol.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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445 participants in 1 patient group

Magnetic Resonance Imaging (MRI) of Breast Cancer

Experimental group

Description:

Contrast-enhanced magnetic resonance imaging (MRI) using the standard department of Radiology MRI screening procedures. The duration of scanning may be variable, but will not exceed 90 minutes.

Treatment:

Procedure: MRI