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Diagnostic Ultrasound for Breast Cancer Screening

N/A
Recruiting
Led By Debbie Bennett, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female subjects ≥ 18 years old with ultrasound visible breast abnormalities (BI-RADS 3*, 4A, 4B, 4C, and 5) referred for ultrasound-guided core needle biopsy or fine needle aspiration
*note that while a BI-RADS 3 assessment is probably benign, a subset of patients with this assessment choose to undergo biopsy rather than follow up imaging)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up completion of enrollment for all patients (estimated to be 87 months)
Awards & highlights

Study Summary

This trial uses a commercial ultrasound transducer and near infrared optical imaging sensors mounted on a hand-held ultrasound probe to co-register ultrasound and optical images of the breast. This unique approach has demonstrated its potential to accurately differentiate between malignant and benign breast abnormalities, as well as predict and monitor the response of breast cancer to neoadjuvant chemotherapy (NAC).

Who is the study for?
This trial is for women aged 18 or older with visible breast abnormalities needing a biopsy. Participants must be able to consent and have specific types of lesions (BI-RADS 3, 4A, B, C, and 5). Excluded are pregnant women, those with certain previous treatments or conditions like implants or small lesions near the skin.Check my eligibility
What is being tested?
The study tests a hand-held probe combining ultrasound and optical sensors to differentiate between benign and malignant breast tissue without invasive biopsies. It aims to reduce unnecessary procedures by improving diagnostic accuracy through imaging tumor-related blood vessels.See study design
What are the potential side effects?
Since this intervention involves non-invasive imaging rather than medication or surgery, significant side effects are not expected. However, there may be minimal discomfort associated with using the handheld probe during the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman over 18 with a breast abnormality needing a biopsy.
Select...
I chose a biopsy over imaging for my probably benign breast finding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~completion of enrollment for all patients (estimated to be 87 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and completion of enrollment for all patients (estimated to be 87 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Breast
Biopsy

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase I - Training SetExperimental Treatment1 Intervention
20 patients will be recruited to undergo US-DOT and CEM to allow for training study readers in assessing US-DOT data, intra-observer variability and to assess inter-observer variability in the assessment of US-DOT data A hand-held hybrid probe will be used for the scans
Group II: Phase 2: Prospective TrialExperimental Treatment1 Intervention
US-DOT (US/NIR) Imaging Exam Breast biopsy or FNA performed (standard of care) A hand-held hybrid probe will be used for the scans

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,374 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,818 Total Patients Enrolled
Debbie Bennett, M.D.Principal InvestigatorWashington University School of Medicine

Media Library

Hand-held hybrid probe Clinical Trial Eligibility Overview. Trial Name: NCT03842358 — N/A
Breast Biopsy Research Study Groups: Phase 2: Prospective Trial, Phase I - Training Set
Breast Biopsy Clinical Trial 2023: Hand-held hybrid probe Highlights & Side Effects. Trial Name: NCT03842358 — N/A
Hand-held hybrid probe 2023 Treatment Timeline for Medical Study. Trial Name: NCT03842358 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participation rate of this research endeavor?

"Affirmative. Clinicaltrials.gov provides evidence that this research is currently admitting participants; it was initially posted on December 13th 2018 and edited most recently in December 2021. The team responsible for the trial seeks to recruit 335 individuals from a single location."

Answered by AI

Are there any vacancies left for participants of this experiment?

"Enrolment is still open for this medical trial, first posted on December 13th 2018 and updated as recently as December 7th 2021."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Diagnostic US for Reduction of Benign Breast Biopsies Using US-guided Optical Tomography
2018. "Diagnostic US for Reduction of Benign Breast Biopsies Using US-guided Optical Tomography". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03842358.
~33 spots leftby Nov 2024
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