Status:
COMPLETED
Quantitative Subharmonic Breast Imaging
Lead Sponsor:
Thomas Jefferson University
Collaborating Sponsors:
National Cancer Institute (NCI)
Lantheus Medical Imaging
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
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 objecti...
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 Die...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2019
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT01490892
Start Date
November 1 2011
End Date
April 5 2019
Last Update
May 6 2025
Active Locations (2)
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1
University of California, San Diego
La Jolla, California, United States, 92093
2
Thomas Jefferson University, Dept of Radiology
Philadelphia, Pennsylvania, United States, 19107