High Resolution 3D Diffusion-weighted Breast MRI

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01315106

Enrollment

Registered

2011-03-15

Start date

2011-03-31

Completion date

2014-01-07

Last updated

2025-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Metastatic Breast Cancer

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.

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.

Interventions

DEVICEMagnetic Resonance Image Scanner

Magnetic Resonance Imaging; 1.5 Tesla or 3 Tesla MRI scanner

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patient scheduled for contrast-enhanced breast MRI to image possible breast cancer. 2\. Female 3\. Age \>18

Exclusion criteria

1. Lactation 2\. Pregnancy 3\. 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. 4\. 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

Design outcomes

Primary

Measure	Time frame
Sensitivity of the new MRI method	8 weeks
Lesion detection rate of the new MRI method	4 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026