Cystic Breast Masses by Contrast Enhanced Ultrasound (CEUS)

NCT02887937 | Completed

• 1 other identifier: HS-16-00483
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

The overarching goal of the proposed research is to evaluate whether qualitative and quantitative parameters in real time contrast enhanced ultrasound (CEUS) can aid in assessing suspicious indeterminate cystic appearing breast masses and ultimately determine whether or not an ultrasound guided biopsy is necessary. The underlying hypothesis is that breast masses (given BIRADS 4) that lack enhancement on CEUS will have a benign histology obtained by ultrasound guided core biopsy and/or surgery. Then, in the future, these non-enhancing cystic lesions can be followed and do not need biopsy intervention.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• lesions of malignant vs. benign biopsy histology

  The proportion of breast masses with presence of contrast uptake on CEUS will be calculated for lesions of malignant vs. benign biopsy histology, grouped by BIRADS categories

  0-2 months

Secondary Outcomes (1)

• classification rule with the CEUS parameters

  11-12 months

Study Arms (4)

Breast Mass 4a-cystic

Contrast Enhanced UltraSound (CEUS) exams will be performed on a ultrasound machine for the 4a-cystic breast masses recommended for biopsy. An intravenous line (IV) line will be inserted into the vein in the arm for the administration of the contrast agent, Definity (10 µL/kg) The patient will be asked to lie on a table for the 4DCT and unenhanced CT procedure and the images will be recorded. For the contrast enhanced ultrasound, the contrast agent will be injected into the IV line. The CEUS will be performed and the images will be recorded. The contrast agent may be administered two to three more times as needed. Scanning will then be repeated with 30 and 90 seconds delay after the IV contrast administration.

Drug: Definity

Breast Mass 4a- non cystic

Contrast Enhanced UltraSound (CEUS) exams will be performed on a ultrasound machine for the 4a-non cystic breast masses recommended for biopsy. An intravenous line (IV) line will be inserted into the vein in the arm for the administration of the contrast agent, Definity (10 µL/kg) The patient will be asked to lie on a table for the 4DCT and unenhanced CT procedure and the images will be recorded. For the contrast enhanced ultrasound, the contrast agent will be injected into the IV line. The CEUS will be performed and the images will be recorded. The contrast agent may be administered two to three more times as needed. Scanning will then be repeated with 30 and 90 seconds delay after the IV contrast administration..

Drug: Definity

Breast Mass 4b

Contrast Enhanced UltraSound (CEUS) exams will be performed on a ultrasound machine for the 4b breast masses recommended for biopsy. An intravenous line (IV) line will be inserted into the vein in the arm for the administration of the contrast agent, Definity (10 µL/kg) The patient will be asked to lie on a table for the 4DCT and unenhanced CT procedure and the images will be recorded. For the contrast enhanced ultrasound, the contrast agent will be injected into the IV line. The CEUS will be performed and the images will be recorded. The contrast agent may be administered two to three more times as needed. Scanning will then be repeated with 30 and 90 seconds delay after the IV contrast administration.

Drug: Definity

Breast Mass 4c

Contrast Enhanced UltraSound (CEUS) exams will be performed on a ultrasound machine for the 4c breast masses recommended for biopsy. An intravenous line (IV) line will be inserted into the vein in the arm for the administration of the contrast agent, Definity (10 µL/kg) The patient will be asked to lie on a table for the 4DCT and unenhanced CT procedure and the images will be recorded. For the contrast enhanced ultrasound, the contrast agent will be injected into the IV line. The CEUS will be performed and the images will be recorded. The contrast agent may be administered two to three more times as needed. Scanning will then be repeated with 30 and 90 seconds delay after the IV contrast administration.

Drug: Definity

Interventions

Definity DRUG

The contrast agent, Definity, 10 µL/kg, will be administered through an intravenous catheter placed in an antecubital vein. Definity is an FDA approved contrast agent for cardiac studies and will be an off-label use in this study. The agent will be injected as a single intravenous bolus followed by a 10 mL saline flush (0.9% NaCl). Images will be recorded with clip function for 90 seconds following the administration of contrast while the probe is stabilized and minimal pressure applied. During this time, qualitative evaluation of tumor enhancement will be observed, and the presence of contrast uptake within the tumor will be categorized.

Also known as: Perflutren

Breast Mass 4a- non cystic; Breast Mass 4a-cystic; Breast Mass 4b; Breast Mass 4c

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will be performed as a prospective study at LAC+USC in the mammography department. Our project will enroll approximately 135 women \> 18 years of age with breast masses evaluated by conventional US given BIRADS 4 and recommended for ultrasound guided biopsy.

You may qualify if:

• \>18 years of age
• recommended for an ultrasound guided biopsy due to breast mass detection

You may not qualify if:

• \< 18 years of age
• prior history of breast cancer
• prior history of biopsy for that specific lesion
• any condition that would be a contraindication to the microbubble contrast agent used in CEUS such as pulmonary hypertension, 3cardiac shunts, and allergy to perflutren.

Sponsors & Collaborators

• University of Southern California: lead
• Wright Foundation: collaborator

Study Sites (1)

USC Department of Radiology

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

perflutren

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sandy C Lee, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 2, 2016
• Study Start: August 16, 2016
• Primary Completion: April 29, 2018
• Study Completion: April 29, 2018
• Last Updated: May 15, 2018

Record last verified: 2018-05

Locations

US (1)