Magnetic Resonance Imaging of Breast Cancer

NCT ID: NCT01035112

Last Updated: 2025-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-04-01

Study Completion Date

2027-05-31

Brief Summary

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

Detailed Description

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Conditions

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Breast Cancer Breast Cancer Non-invasive Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Magnetic Resonance Imaging (MRI) of Breast Cancer

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.

Group Type EXPERIMENTAL

MRI

Intervention Type PROCEDURE

Interventions

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MRI

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bruce L Daniel

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jocelyn Steffan

Role: CONTACT

650-725-1812

Facility Contacts

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Jocelyn Steffen

Role: primary

650-725-1812

Other Identifiers

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13IB-0074

Identifier Type: OTHER

Identifier Source: secondary_id

75763

Identifier Type: OTHER

Identifier Source: secondary_id

R01CA249893

Identifier Type: NIH

Identifier Source: secondary_id

View Link

BRSNSTU0004

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2024-01929

Identifier Type: REGISTRY

Identifier Source: secondary_id

IRB-10748

Identifier Type: -

Identifier Source: org_study_id

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