Advanced Ultrasound Signal Processing of Suspicious Breast Images

NCT07206888 | Enrolling By Invitation

• 1 other identifier: IRB00127110
• Study Type: observational
• Target: 252
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate recent developments in ultrasound signal processing to determine if these new techniques can enhance the visibility of important features of interest in breast ultrasound images. Ultrasound signals obtained from both standard ultrasound imaging and ultrasound imaging combined with light (also known as photoacoustic imaging) will be investigated.

Conditions

Breast Cancer; Breast Cyst; Microcalcification

Keywords

cyst; mass; diagnostic screening; ultrasound; mammography

Outcome Measures

Primary Outcomes (6)

• Image quality

  compare advanced beamforming and benchmark against a conventional beamforming technique by measuring and comparing standard image quality metrics

  baseline

• Number of microcalcifications

  baseline

• Binary visibility of microcalcifications

  Clinicians (members of study team) will be shown images and record 'yes' if microcalcifications are present and 'no' if not.

  baseline

• Subjective ratings

  Clinicians (members of study team) will be shown images and asked to provide subjective ratings of the images

  baseline

• Distinction of mass contents: solid vs. fluid

  After examining the coherence measurements obtained from advanced beamforming techniques, the investigators will determine the ability of this quantitative information to distinguish between solid and fluid-filled masses

  baseline

• Distinction of mass contents: benign vs. malignant

  After examining the coherence measurements obtained from advanced beamforming techniques, the investigators will determine the ability of this quantitative information to distinguish between solid malignant masses vs. solid benign masses

  baseline

Secondary Outcomes (4)

• Number of true positives

  baseline

• Number of false positives

  baseline

• Number of true negatives

  baseline

• Number of false negatives

  baseline

Interventions

Imaging DIAGNOSTIC_TEST

Ultrasound imaging or ultrasound imaging with light (i.e., photoacoustic imaging)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Johns Hopkins Hospital

You may qualify if:

• Female adults (age \>18 years) with at least one of the following:
• Macrocalcification(s) detected in x-ray 2D or 3D mammography images
• Macrocalcification(s) located next to cyst (or other identifiable landmark on an ultrasound image)
• A cyst, mass, or finding detected in diagnostic/screening ultrasound or mammography

You may not qualify if:

• (when performing ultrasound imaging only)
• Children (age \< 18 years) are excluded
• (when performing ultrasound imaging with light, i.e., optoacoustic imaging)
• Children (age \< 18 years) are excluded
• Is pregnant
• Has open sores including insect bites, rash, poison ivy, and chafing on the skin of the ipsilateral breast
• Is experiencing phototoxicity associated with currently taking, or having taken, photosensitizing agents within the previous 72 hours such as sulfonamides, ampicillin, tetracycline
• Is currently undergoing phototherapy
• Has a history of any photosensitive disease (e.g., porphyria, lupus erythematosus) or is undergoing treatment for a photosensitive disease and is experiencing photosensitivity

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Outpatient Center

Baltimore, Maryland, 21209, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Breast Cyst; Calcinosis; Cysts; Arachnodactyly

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Muyinatu Bell, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 3, 2025
• Study Start: April 25, 2017
• Primary Completion (Estimated): January 1, 2037
• Study Completion (Estimated): January 1, 2037
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)