Recruiting

MRI

Sponsor:

Stanford University

Code:

NCT01035112

Conditions

Breast Cancer

Breast Cancer Non-invasive Breast Cancer

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Accepted

Interventions

MRI

Study Details

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.

Conditions

Breast Cancer

Breast Cancer Non-invasive Breast Cancer

Study ID

NCT01035112

Start date

Apr 1, 1995

Status verified date

Jun, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Accepted

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

Enrollment

500 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

MRI

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Jocelyn Steffan

650-725-1812jsteffen@stanford.edu

Locations

Stanford University School of Medicine

Recruiting

Stanford, California, United States, 94305

Contacts

Jocelyn Steffen

650-725-1812jsteffen@stanford.edu

Principal Investigator:

Bruce Lewis Daniel

More Information

Sponsor

Stanford University

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-07-01.