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Contrast Enhanced Ultrasound Medical Imaging for Identifying Breast Masses

RECRUITINGPhase 1Sponsored by University of Southern California
Actively Recruiting
PhasePhase 1
SponsorUniversity of Southern California
Started2020-11-05
Est. completion2026-11-05
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
Locations2 sites

Summary

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.

Eligibility

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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

Conditions3

Breast CancerBreast CarcinomaCancer

Locations2 sites

Los Angeles County-USC Medical Center
Los Angeles, California, 90033
Janet Jaime323-865-3205Janet.Jaime@med.usc.edu
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Janet Jaime323-865-3205Janet.Jaime@med.usc.edu

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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