Quantitative Subharmonic Breast Imaging

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 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: February 7, 2014
Last verified: February 2014

December 8, 2011
February 7, 2014
November 2011
February 2015   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01490892 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Quantitative Subharmonic Breast Imaging
Quantitative Subharmonic Breast Imaging

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.

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.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Breast Cancer
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
Experimental: single arm
Intervention: Drug: 3D HI and SHI of ultrasound contrast agent
Forsberg F, Piccoli CW, Merton DA, Palazzo JJ, Hall AL. Breast lesions: imaging with contrast-enhanced subharmonic US--initial experience. Radiology. 2007 Sep;244(3):718-26. Epub 2007 Aug 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
450
February 2015
February 2015   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
United States
 
NCT01490892
11F.438, R01CA140338
Yes
Thomas Jefferson University
Thomas Jefferson University
  • National Cancer Institute (NCI)
  • Lantheus Medical Imaging
  • University of California, San Diego
Principal Investigator: Flemming Forsberg, phD Thomas Jefferson University
Thomas Jefferson University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP