NCT01315106

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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 Start

First participant enrolled

March 1, 2011

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 15, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2014

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

2.9 years

First QC Date

March 11, 2011

Last Update Submit

March 13, 2025

Conditions

Breast CancerMetastatic Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • Sensitivity of the new MRI method

    8 weeks

  • Lesion detection rate of the new MRI method

    4 weeks

Interventions

Magnetic Resonance Image ScannerDEVICE

Magnetic Resonance Imaging; 1.5 Tesla or 3 Tesla MRI scanner

Also known as: MRI

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stanford Radiology Department MRI facilities

You may qualify if:

  • \. Female

You may not qualify if:

  • \. Pregnancy
  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2011

First Posted

March 15, 2011

Study Start

March 1, 2011

Primary Completion

January 7, 2014

Study Completion

January 7, 2014

Last Updated

March 18, 2025

Record last verified: 2025-03

Locations

US(1)