NCT01035112

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
12mo left

Started Apr 1995

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Apr 1995May 2027

Study Start

First participant enrolled

April 1, 1995

Completed
14.7 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2009

Completed
17.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

July 2, 2025

Status Verified

June 1, 2025

Enrollment Period

32.1 years

First QC Date

December 17, 2009

Last Update Submit

June 27, 2025

Conditions

Breast CancerBreast Cancer Non-invasive Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Magnetic Resonance Imaging (MRI) of Breast Cancer

EXPERIMENTAL

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.

Procedure: MRI

Interventions

MRIPROCEDURE
Magnetic Resonance Imaging (MRI) of Breast Cancer

Eligibility Criteria

Age21 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale by birth
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Bruce L Daniel

    Stanford University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jocelyn Steffan

CONTACT

650-725-1812jsteffen@stanford.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2009

First Posted

December 18, 2009

Study Start

April 1, 1995

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

July 2, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)