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Enrolling by invitationNCT07206888AUSPICIOUSUpdated Oct 29, 2026

Advanced Ultrasound Signal Processing of Suspicious Breast Images

An observational study in Breast Cancer, Breast Cyst and Microcalcification, sponsored by Johns Hopkins University. Enrolling by invitation at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Johns Hopkins University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
252
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Cancer
  • Breast Cyst
  • Microcalcification

Keywords

  • cyst
  • mass
  • diagnostic screening
  • ultrasound
  • mammography
03

In context

Breast Neoplasms

14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.

This study's planned enrollment of 252 is above the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.

Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Johns Hopkins Hospital

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
252 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testImaging

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

06

What researchers measure

Primary outcomes

  1. Image quality

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

    Time frame: baseline

  2. Number of microcalcifications

    Time frame: baseline

  3. Binary visibility of microcalcifications

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

    Time frame: baseline

  4. Subjective ratings

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

    Time frame: baseline

  5. 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

    Time frame: baseline

  6. 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

    Time frame: baseline

Secondary outcomes

  1. Number of true positives

    The number of positive results that are correct

    Time frame: baseline

  2. Number of false positives

    The number of positive results that are incorrect

    Time frame: baseline

  3. Number of true negatives

    The number of negative results that are correct

    Time frame: baseline

  4. Number of false negatives

    The number of negative results that are incorrect

    Time frame: baseline

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07206888
Responsible party
Sponsor
First posted
Oct 3, 2025
Start date
Apr 25, 2017
Primary completion
Jan 1, 2037 (estimated)
Completion
Jan 1, 2037 (estimated)
Last update
Oct 29, 2026

Study contacts

Muyinatu Bell, PhD
principal investigator · Johns Hopkins University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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