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NCT03842358 · ClinicalTrials.gov registry record · NA
Diagnostic US for Reduction of Benign Breast Biopsies Using US-guided Optical Tomography
A NA study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 298
- Enrollment target
NCT03842358: Completed NA study, sponsored by Washington University School of Medicine.
NCT03842358 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 298 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03842358, a NA study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 298 participants
- Enrollment target
Study Summary
Ultrasound-guided diffuse optical tomography (DOT) has demonstrated its potential role in differentiating malignant and benign breast abnormalities and in predicting and monitoring the neoadjuvant chemotherapy (NAC) response of breast cancer. This unique approach employs a commercial ultrasound (US) transducer and near infrared (NIR) optical imaging sensors mounted on a hand-held US probe. The co-registered US is used for lesion localization, and optical sensors are used for imaging tumor related vascularity.
Primary Outcome
-BI-RADS scores without and then with optical data will be rendered by study radiologists. Radiologists will be blinded to the biopsy exam and pathology outcomes. Optical data including total Hemoglobin concentration will be provided by the bioengineering team. Benign biopsy reduction will be calculated as the proportion of reads (CI \& US-DOT subtract CI) with a non- suspicious assessment, i.e. BIRADS 2 'benign' or BIRADS 3 'probably benign', divided by the denominator of total reads with no ca
Interventions
- DEVICE Hand-held hybrid probe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 298 participants |
| Start Date | 2019-03-05 |
| Est. Completion | 2024-07-30 |
| Phase | NA |
What the finished NCT03842358 record still lists
NCT03842358 is an interventional study that assigns participants to a tested intervention. The registered 298 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 1 intervention - of which Hand-held hybrid probe is the first listed.
NCT03842358 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03842358 about?
NCT03842358 is a clinical study titled "Diagnostic US for Reduction of Benign Breast Biopsies Using US-guided Optical Tomography". Ultrasound-guided diffuse optical tomography (DOT) has demonstrated its potential role in differentiating malignant and benign breast abnormalities and in predicting and monitoring the neoadjuvant chemotherapy (NAC) response of breast cancer. This unique approach employs a commercial ultrasound (US)...
What is the current status of trial NCT03842358?
This trial is currently completed. It is a NA study. The enrollment target is 298 participants. The study started on 2019-03-05. Estimated completion is 2024-07-30.
What interventions are being tested in trial NCT03842358?
The interventions under investigation include: Hand-held hybrid probe (DEVICE).
Who is sponsoring clinical trial NCT03842358?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03842358's enrollment target sits among peer trials
298 371st of 2000 higher than 1,629 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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