Advanced Ultrasound Signal Processing of Suspicious Breast Images

NCT ID: NCT07206888

Last Updated: 2025-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

252 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-25

Study Completion Date

2037-01-01

Brief Summary

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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

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Conditions

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Breast Cancer Breast Cyst Microcalcification

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Imaging

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Muyinatu Bell, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Outpatient Center

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00127110

Identifier Type: -

Identifier Source: org_study_id

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