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NCT04491864 · ClinicalTrials.gov registry record
DWIBS-MRI: An Adjunct to the Traditional Diagnostic Breast Imaging Evaluation
A clinical trial, sponsored by Baylor Research Institute.
- Terminated
- Registry status
- 11
- Enrollment target
NCT04491864: Clinical Trial study, sponsored by Baylor Research Institute.
NCT04491864 is a clinical trial that was terminated before completion, run by Baylor Research Institute. The registered enrollment target is 11 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04491864 was terminated before completion, sponsored by Baylor Research Institute.
- TERMINATED
- Registry status
- 11 participants
- Enrollment target
Study 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.
Primary Outcome
• To determine if MRI DWIBS can accurately identify suspicious lesions previously categorized on mammography and sonography as potentially malignant.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2019-03-11 |
| Est. Completion | 2022-07-01 |
Why NCT04491864 stopped before completion
NCT04491864 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 11 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT04491864 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04491864 about?
NCT04491864 is a clinical study titled "DWIBS-MRI: An Adjunct to the Traditional Diagnostic Breast Imaging Evaluation". 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. A...
What is the current status of trial NCT04491864?
This trial is currently terminated. The enrollment target is 11 participants. The study started on 2019-03-11. Estimated completion is 2022-07-01.
Who is sponsoring clinical trial NCT04491864?
This trial is sponsored by Baylor Research Institute, which has 180 total clinical trials registered on ClinicalTrials.gov.
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