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NCT02638935 · ClinicalTrials.gov registry record · NA
Evaluation of Virtual Touch Tissue Imaging Quantification (VTIQ - 2D-SWE) in the Assessment of BI-RADS® 3 and 4 Lesions
A NA study, sponsored by Heidelberg University.
- Completed
- Registry status
- NA
- Development phase
- 1,304
- Enrollment target
NCT02638935: Completed NA study, sponsored by Heidelberg University.
NCT02638935 is a NA study that has completed, run by Heidelberg University. The registered enrollment target is 1,304 participants, roughly in line with the 1,404-participant average among 58,714 other NA trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02638935, a NA study, has completed, sponsored by Heidelberg University.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,304 participants
- Enrollment target
Study Summary
The primary aim of this study is to evaluate if VTIQ in addition to BI-RADS® categorization can improve the diagnostic accuracy with respect to detection of malignancies, in particular for BI-RADS® categories 3 and 4a. The idea of the study is to restage all patients in categories 3 and 4a according to a predefined VTIQ cut-off value of ≥ 3.5 m/s (37 kPa).
Primary Outcome
Hierarchical testing of the main statistical hypotheses H0\_1, H0\_2, H0\_3 (test for H0\_1 defines a gatekeeper) to evaluate the diagnostic accuracy of VTIQ in the differentiation of BI-RADS® 3 and 4a lesions: H0\_1: The proportion of malignancies for group A (BI-RADS 4a, VTIQ ≥ cut-off) is less or equal to the proportion of malignancies for group B (BI-RADS 4a, VTIQ \< cut-off). versus H1\_1: The proportion of malignancies for group A is higher than the proportion of malignancies for group
Interventions
- DEVICE Ultrasound- Virtual Touch Tissue Imaging Quantification
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,304 participants |
| Start Date | 2016-02 |
| Est. Completion | 2019-03 |
| Phase | NA |
What the finished NCT02638935 record still lists
NCT02638935 is an interventional study that assigns participants to a tested intervention. Its 1,304 participants enrollment target places it among the larger protocols in the corpus, roughly in line with the 1,404-participant average among 58,714 other NA trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Ultrasound- Virtual Touch Tissue Imaging Quantification is the first listed.
NCT02638935 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02638935 about?
NCT02638935 is a clinical study titled "Evaluation of Virtual Touch Tissue Imaging Quantification (VTIQ - 2D-SWE) in the Assessment of BI-RADS® 3 and 4 Lesions". The primary aim of this study is to evaluate if VTIQ in addition to BI-RADS® categorization can improve the diagnostic accuracy with respect to detection of malignancies, in particular for BI-RADS® categories 3 and 4a. The idea of the study is to restage all patients in categories 3 and 4a according...
What is the current status of trial NCT02638935?
This trial is currently completed. It is a NA study. The enrollment target is 1,304 participants. The study started on 2016-02. Estimated completion is 2019-03.
What interventions are being tested in trial NCT02638935?
The interventions under investigation include: Ultrasound- Virtual Touch Tissue Imaging Quantification (DEVICE).
Who is sponsoring clinical trial NCT02638935?
This trial is sponsored by Heidelberg University, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02638935's enrollment target sits among peer trials
1,304 76th of 2000 higher than 1,925 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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