Quantitative Subharmonic Breast Imaging
18 Years
N/A
Female
Breast Cancer
Trial Information
Quantitative Subharmonic Breast Imaging
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.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Breast lesion characterization with 3D SHI
Outcome Description:
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).
Outcome Time Frame:
2 hours
Safety Issue:
No
Principal Investigator
Flemming Forsberg, phD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Thomas Jefferson University
Authority:
United States: Food and Drug Administration
Study ID:
11F.438
NCT ID:
NCT01490892
Start Date:
November 2011
Completion Date:
February 2015
Related Keywords:
- Breast Cancer
- breast abnormality
- ultrasound imaging
- ultrasound contrast agent
- subharmonic imaging
- Breast Neoplasms
Name | Location |
|---|---|
| University of California, San Diego | La Jolla, California 92037-1709 |
| Thomas Jefferson University, Dept of Radiology | Philadelphia, Pennsylvania 19107 |
