Quantitative Subharmonic Breast Imaging

NCT01490892 | Completed Phase 4 Results DMC

• 3 other identifiers: 11F.438R01CA140338JT 2179
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Breast Cancer

Keywords

breast abnormality; ultrasound imaging; ultrasound contrast agent; subharmonic imaging

Outcome Measures

Primary Outcomes (1)

• Number of Breast Cancer Lesions Characterized as Malignant or Benign With 3D SHI, Harmonic Imaging (HI) or Power Doppler Imaging (PDI)

  Characterization of benign and malignant breast cancer lesions is compared by each imaging method which evaluates vascular activity. Imaging methods to be compared are 3D Subharmonic imaging (SHI) or pulse inversion harmonic imaging (HI), fundamental grayscale ultrasound (US) or power Doppler imaging (PDI). Data will be analyzed qualitatively.

  2 hours

Secondary Outcomes (1)

• Change in Vascular Volume of Breast Lesions as Assessed by Subharmonic Imaging (SHI) Signal Intensity

  2 hours

Study Arms (1)

3D HI and SHI of UCA

EXPERIMENTAL

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)

Drug: 3D HI and SHI of UCA

Interventions

3D HI and SHI of UCA DRUG

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)

Also known as: Definity

3D HI and SHI of UCA

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thomas Jefferson University: lead
• National Cancer Institute (NCI): collaborator
• Lantheus Medical Imaging: collaborator
• University of California, San Diego: collaborator

Study Sites (2)

University of California, San Diego

La Jolla, California, 92093, United States

Location

Thomas Jefferson University, Dept of Radiology

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• 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. doi: 10.1148/radiol.2443061588. Epub 2007 Aug 9.

  PMID: 17690324 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

perflutren

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Flemming Forsberg
• Organization: Sidney Kimmel Cancer Center at Thomas Jefferson University

flemming.forsberg@jefferson.edu

215-955-4870

Study Officials

• Flemming Forsberg, phD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2011
• First Posted: December 13, 2011
• Study Start: November 1, 2011
• Primary Completion: April 5, 2019
• Study Completion: April 5, 2019
• Last Updated: May 6, 2025
• Results First Posted: January 13, 2020

Record last verified: 2025-05

Locations

US (2)