Magnetic Resonance Imaging of Breast Cancer

Breast Cancer Clinical Trial

Official title:

Magnetic Resonance Imaging of Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01035112
• Other study ID #: IRB-10748
• Secondary ID: 13IB-007475763CA
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 1995
• Est. completion date: May 2027

Study information

• Verified date: March 2023
• Source: Stanford University
• Contact: Jocelyn Steffan
• Phone: 650-725-1812
• Email: jsteffen[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 445
• Est. completion date: May 2027
• Est. primary completion date: May 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Non-invasive Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• MRI

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare magnetic resonance imaging (MRI) with more well established diagnostic imaging techniques to determine which method best finds and defines breast cancer.		Length of one MRI scan