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RecruitingPhase 1

Contrast Enhanced Ultrasound Medical Imaging for Identifying Breast Masses

Characterizing Breast Masses Using an Integrative Framework of Machine Learning and Radiomics

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Ultrasound, Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "This clinical trial investigates the role of contrast enhanced ultrasound (CEUS) in identifying cystic breast masses as benign or malignant."
  • "Ultrasounds are widely used to diagnose many diseases in the body."
  • "To examine and compare the distribution of CEUS parameters in breast masses that were evaluated as Breast Imaging Reporting and Data System (BI-RADS) 4a, 4b, 4c or 5 by conventional ultrasound (US) and were recommended for ultrasound guided biopsy, and to evaluate whether these parameters can be used to classify suspicious cystic-appearing breast masses as benign or malignant."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

This clinical trial investigates the role of contrast enhanced ultrasound (CEUS) in identifying cystic breast masses as benign or malignant. Ultrasound is a diagnostic imaging test that uses sound waves to make pictures of the body without using radiation (x-rays). Ultrasounds are widely used to diagnose many diseases in the body. This trial may help researchers learn if using CEUS will help in determining whether or not an ultrasound guided biopsy is necessary.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria: * Newly diagnosed breast masses assigned as BIRADS 4a, 4b, 4c or 5 by conventional US and recommended for ultrasound guided biopsy * Age \>= 18 years * Female Exclusion Criteria: * Contraindications to microbubble contrast: Patients who have a known pulmonary hypertension and any known hypersensitivity to US contrast agent * Women with renal failure or insufficiency (only if patient is receiving CESM scan) * Women with Iodine contrast allergy (only if patient is receiving CESM scan) * Women with the largest side of the mass measuring ≤ 1 cm (only if patient is receiving CEUS scan) * Women who are pregnant, possibly pregnant, or lactating * Women currently undergoing neoadjuvant chemotherapy * Women \< 18 years of age * Patient ≤ 30 years (only if patient is receiving CESM scan) * Masses in the same breast that had prior lumpectomy for cancer * Women with cancer in the same breast will be excluded however, women with cancer in the contralateral breast will be eligible to participate in the study * Women with an allergy to perflutren (only if patient is receiving CEUS scan) * Prior history of biopsy for that specific lesion * Women with breast implants

Study sites (2)

CA