Advanced Ultrasound Signal Processing for Breast Imaging

• Conditions: Breast Cancer; Breast Cyst; Microcalcification

• Registration Number: NCT07206888
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-25
• Study First Submitted: 2025-09-23
• Status Verified: 2025-10
• Study First Submitted QC: 2025-10-01
• Last Update Submitted: 2025-10-01
• Study First Posted: 2025-10-03
• Last Update Posted: 2025-10-03
• Primary Completion: 2037-01-01
• Study Completion: 2037-01-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 252

Inclusion Criteria

• 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

Exclusion Criteria

(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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Image quality	baseline	compare advanced beamforming and benchmark against a conventional beamforming technique by measuring and comparing standard image quality metrics
Number of microcalcifications	baseline
Subjective ratings	baseline	Clinicians (members of study team) will be shown images and asked to provide subjective ratings of the images
Binary visibility of microcalcifications	baseline	Clinicians (members of study team) will be shown images and record 'yes' if microcalcifications are present and 'no' if not.
Distinction of mass contents: solid vs. fluid	baseline	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
Distinction of mass contents: benign vs. malignant	baseline	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

Secondary Outcome Measures

Name	Time	Method
Number of false positives	baseline	The number of positive results that are incorrect
Number of true positives	baseline	The number of positive results that are correct
Number of true negatives	baseline	The number of negative results that are correct
Number of false negatives	baseline	The number of negative results that are incorrect

Trial Locations

Locations (1)

Johns Hopkins Outpatient Center; 🇺🇸 Baltimore, Maryland, United States