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Enrolling by Invitation

NCT Number: NCT07206888

Advanced Ultrasound Signal Processing of Suspicious Breast Images

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.

Enrolling by Invitation

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Key information

Conditions

Breast Cancer Arachnodactyly Breast Cyst Breast Diseases Breast Neoplasms Calcinosis Calcium Metabolism Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cysts Limb Deformities, Congenital Metabolic Diseases Microcalcification Musculoskeletal Abnormalities Musculoskeletal Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Johns Hopkins Outpatient Center

Baltimore, Maryland, 21209, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imaging

Diagnostic Test

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

Primary outcomes

  1. Image quality

    Time frame: baseline

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

  2. Number of microcalcifications

    Time frame: baseline

  3. Binary visibility of microcalcifications

    Time frame: baseline

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

  4. Subjective ratings

    Time frame: baseline

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

  5. Distinction of mass contents: solid vs. fluid

    Time frame: 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

  6. Distinction of mass contents: benign vs. malignant

    Time frame: 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 outcomes

  1. Number of true positives

    Time frame: baseline

    The number of positive results that are correct

  2. Number of false positives

    Time frame: baseline

    The number of positive results that are incorrect

  3. Number of true negatives

    Time frame: baseline

    The number of negative results that are correct

  4. Number of false negatives

    Time frame: baseline

    The number of negative results that are incorrect

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

Advanced Ultrasound Beamforming Methods for Breast Imaging

Acronym: AUSPICIOUS

Important dates

Study start
2017
Primary completion
2037
Study completion
2037
First posted
Oct 3, 2025
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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