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Magnetic Resonance Imaging of Breast Cancer

Primary Purpose

Breast Cancer, Breast Cancer Non-invasive Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Stanford University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Magnetic Resonance Imaging (MRI) of Breast Cancer

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 17, 2009
Last Updated
March 23, 2023
Sponsor
Stanford University
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01035112
Brief Title
Magnetic Resonance Imaging of Breast Cancer
Official Title
Magnetic Resonance Imaging of Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 1995 (Actual)
Primary Completion Date
May 2027 (Anticipated)
Study Completion Date
May 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Cancer Non-invasive Breast Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
445 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Magnetic Resonance Imaging (MRI) of Breast Cancer
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
MRI
Primary Outcome Measure Information:
Title
To compare magnetic resonance imaging (MRI) with more well established diagnostic imaging techniques to determine which method best finds and defines breast cancer.
Time Frame
Length of one MRI scan

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
female by birth
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jocelyn Steffan
Phone
650-725-1812
Email
jsteffen@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce L Daniel
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jocelyn Steffen
Phone
650-725-1812
Email
jsteffen@stanford.edu
First Name & Middle Initial & Last Name & Degree
Bruce Lewis Daniel
First Name & Middle Initial & Last Name & Degree
Brian Andrew Hargreaves
First Name & Middle Initial & Last Name & Degree
Robert J Herfkens

12. IPD Sharing Statement

Plan to Share IPD
No

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Magnetic Resonance Imaging of Breast Cancer

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