Quantitative Subharmonic Breast Imaging

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Thomas Jefferson University
Sponsor:
Collaborators:
Lantheus Medical Imaging
University of California, San Diego
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01490892
First received: December 8, 2011
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

This is a non-randomized trial of 450 women with a breast abnormality, who are scheduled for a breast biopsy of this abnormality. The study will be conducted at two clinical sites. The primary objective of this trial is:

To evaluate if quantitative 3D Subharmonic imaging (SHI) or pulse inversion harmonic imaging (HI) can improve the characterization of benign and malignant breast masses (independently or in combination with other imaging modes) compared to x-ray mammography, fundamental grayscale ultrasound (US) or power Doppler imaging (PDI).

The secondary aim of this trial is:

To compare quantitative (bifurcations & vessel length) and semi-quantitative (blood pool & parametric imaging) measures of the vascular morphology of breast lesions determined by pathology and by SHI.


Condition Intervention Phase
Breast Cancer
Drug: 3D HI and SHI of ultrasound contrast agent
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Quantitative Subharmonic Breast Imaging

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Breast lesion characterization with 3D SHI [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    To evaluate if quantitative 3D Subharmonic imaging (SHI) or pulse inversion harmonic imaging (HI) can improve the characterization of benign and malignant breast masses (independently or in combination with other imaging modes) compared to x-ray mammography, fundamental grayscale ultrasound (US) or power Doppler imaging (PDI).


Secondary Outcome Measures:
  • Quantitative SHI measures for breast lesion characterization [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    To compare quantitative (bifurcations & vessel length) and semi-quantitative (blood pool & parametric imaging) measures of the vascular morphology of breast lesions determined by pathology and by SHI.


Estimated Enrollment: 450
Study Start Date: November 2011
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single arm Drug: 3D HI and SHI of ultrasound contrast agent
Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)
Other Name: Definity

Detailed Description:

This is an open-label, non-randomized trial that will be conducted at two clinical sites (the Breast Imaging Centers at Thomas Jefferson University (TJU) Hospital and University of California, San Diego (UCSD) Hospital). All 450 subjects will receive at most two IV bolus injections of Definity (Lantheus Medical Imaging, Billerica, MA), will undergo an unenhanced (baseline) and Definity contrast-enhanced US imaging study for evaluation of a breast mass or breast abnormality without mass, and will be scheduled to undergo a clinically indicated biopsy of the breast lesion under investigation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be a female diagnosed by x-ray mammography (performed within 90 days prior to the study procedure) as having a solid breast mass or abnormal area without a mass.
  • Be scheduled for a biopsy (core / excisional / lumpectomy) of the mass or region of abnormality or for mastectomy within 30 days after this study procedure.
  • Be at least 18 years of age.
  • Be medically stable.
  • If a female of child-bearing potential, must have a negative pregnancy test.
  • Have signed Informed Consent to participate in the study.

Exclusion Criteria:

  • Males
  • Females who are pregnant or nursing.
  • Patients whose breast lesion is unequivocally a cyst by unenhanced US.
  • Patients currently on chemotherapy or with other primary cancers requiring systemic treatment.
  • Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:
  • Patients on life support or in a critical care unit.
  • Patients with unstable occlusive disease (eg, crescendo angina)
  • Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia.
  • Patients with uncontrolled congestive heart failure (NYHA Class IV)
  • Patients with recent cerebral hemorrhage.
  • Patients with clinically significant and unstable renal and/or liver disease (eg, transplant recipients in rejection)
  • Patients who have undergone surgery within 24 hours prior to the study sonographic examination.
  • Patients with known hypersensitivity to perflutren
  • Patients who have received any contrast medium (X-ray, MRI, CT, of US) in the 24 hours prior to the research US exam
  • Patients with cardiac shunts.
  • Patients with congenital heart defects.
  • Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli.
  • Patients with confirmed or suspected liver lesions.
  • Patients with respiratory distress syndrome.
  • Patients who have had excisional biopsy/lumpectomy of the current area of interest within the past 6 weeks.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01490892

Locations
United States, California
University of California, San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Robert Mattrey, MD    619-543-6766    rmattrey@ucsd.edu   
Contact: Rose Ramirez    619-543-3515    rgramirez@ucsd.edu   
Principal Investigator: Robert Mattrey, MD         
United States, Pennsylvania
Thomas Jefferson University, Dept of Radiology Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Flemming Forsberg, PhD    215-955-4870    flemming.forsberg@jefferson.edu   
Contact: Colleen Dascenzo, CRA    215-955-8606    Colleen.Dascenzo@jefferson.edu   
Principal Investigator: Flemming Forsberg, PhD         
Sub-Investigator: Barbara C Cavanaugh, MD         
Sub-Investigator: Anina Wilkes, MD         
Sponsors and Collaborators
Thomas Jefferson University
Lantheus Medical Imaging
University of California, San Diego
Investigators
Principal Investigator: Flemming Forsberg, phD Thomas Jefferson University
  More Information

Publications:
Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01490892     History of Changes
Other Study ID Numbers: 11F.438, R01CA140338
Study First Received: December 8, 2011
Last Updated: August 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Thomas Jefferson University:
breast abnormality
ultrasound imaging
ultrasound contrast agent
subharmonic imaging

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 30, 2014