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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date May 2024
Source Stanford University
Contact Jocelyn Steffan
Phone 650-725-1812
Email jsteffen@stanford.edu
Is FDA regulated No
Health authority
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.

Study Design


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
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