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TerminatedNCT01315106Updated Mar 18, 2025

High Resolution 3D Diffusion-weighted Breast MRI

An observational study in Breast Cancer and Metastatic Breast Cancer, sponsored by Stanford University. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-18.

Sponsored by Stanford University · Observational

Why this study was terminated
Business Decision
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
Female
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Study summary

The purpose of this study is to determine how well a new MRI technique called "High resolution 3D diffusion-weighted breast MRI" detects breast cancer.

Read the detailed description

The objective of this study is to assess the diagnostic accuracy of a new non-contrast MRI method for breast cancer detection. The study design is a single arm observational study. The new technique will be added on to the standard sequences that a women undergoes during a breast MRI. The resulting images will be compared with her standard breast MRI images, and with results of subsequent pathology.

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Conditions studied

  • Breast Cancer
  • Metastatic Breast Cancer

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03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 50 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Stanford Radiology Department MRI facilities

Eligibility criteria

Inclusion Criteria:1. Patient scheduled for contrast-enhanced breast MRI to image possible breast cancer.

  1. Female
  1. Age >18 Exclusion Criteria:1. Lactation
  1. Pregnancy
  1. Patient undergoing chemotherapy. These patients are excluded because chemotherapy changes the biology of breast cancers. Since the ultimate objective of the research is to develop a new imaging method for breast MRI screening (detection of previously unknown tumors), results in treated tumors would not be relevant. Including treated tumors could yield a misleading assessment of the performance of the new method since treated tumors have different imaging characteristics than de novo tumors.
  1. Patient scheduled for pre-operative chemotherapy. These patients are excluded if they are going to be treated only on the basis of fine needle aspiration. The project seeks to correlate all tumors detected with standard histopathology of their untreated neoplasm. This exclusion criteria will be very unusual because most patients planning neoadjuvant chemotherapy do so on the basis of a pre-chemo core needle biopsy, which provide adequate histopathologic proof necessary for enrollment.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)

Interventions

  • DeviceMagnetic Resonance Image Scanner

    Magnetic Resonance Imaging; 1.5 Tesla or 3 Tesla MRI scanner

    Also known as: MRI

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What researchers measure

Primary outcomes

  1. Sensitivity of the new MRI method

    Time frame: 8 weeks

  2. Lesion detection rate of the new MRI method

    Time frame: 4 weeks

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Study locations

1 site
  • Stanford University School of Medicine
    Stanford, California 94305, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01315106
Lead sponsor
Stanford University
Collaborators
National Institutes of Health (NIH), National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Responsible party
Sponsor
First posted
Mar 15, 2011
Start date
Mar 2011
Primary completion
Jan 7, 2014
Completion
Jan 7, 2014
Last update
Mar 18, 2025

Study contacts

Bruce L. Daniel
principal investigator · Stanford University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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