DWIBS-MRI: An Adjunct to the Traditional Diagnostic Breast Imaging Evaluation

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04491864

Acronym

DWIBS

Enrollment

Registered

2020-07-29

Start date

2019-03-11

Completion date

2022-07-01

Last updated

2026-01-26

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

Conditions

Breast Cancer

Brief summary

1.1. Primary Objectives * To determine if MRI DWIBS can accurately identify suspicious lesions previously categorized on mammography and sonography as potentially malignant. * We will also validate whether DWIBS-MRI ADC values can be used to accurately differentiate benign from malignant lesions. Additionally, because it is not known whether tumor type or growth rate (Ki67 values) will affect our results, we will include these parameters in our analysis. * Once we validate the use of DWIBS-MRI ADC values to determine malignancy, can we establish an ADC threshold value to decrease the number of false positive biopsies that are performed while still maintaining a zero false negative rate? * This study will also assess the correlation between ADC values and the Ki-67 proliferative index of malignant lesions.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

30 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* A patient will be eligible for inclusion in this study if she meets all of the following criteria: 1. \>30 years of age 2. Genetic Female 3. Suspected diagnosis of BIRADS 4 or BIRADS 5 masses and/or asymmetries greater than 1 centimeter based on standard 2D/3D mammogram and ultrasound imaging.

Exclusion criteria

* A patient is ineligible for inclusion in this study if she meets any of the following criteria: 1. Prior biopsy of suspicious lesion 2. Breast implants 3. Prior history of breast cancer 4. Patient has a pacemaker 5. Contraindications to use of MRI imaging (metal implants, etc.) 6. Woman pregnant or lactating 7. Calcifications as only findings present for a suspicious lesion

Design outcomes

Primary

Measure	Time frame	Description
MRI DWIBS Accuracy	1 month	• To determine if MRI DWIBS can accurately identify suspicious lesions previously categorized on mammography and sonography as potentially malignant.
Validate DWIBS-MRI	1 month	• We will also validate whether DWIBS-MRI ADC values can be used to accurately differentiate benign from malignant lesions. Additionally, because it is not known whether tumor type or growth rate (Ki67 values) will affect our results, we will include these parameters in our analysis.

Countries

United States

Outcome results