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Quantitative Subharmonic Breast Imaging

NCT01490892 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2025-05-06

Study results available
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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

Interventions

DRUG

3D HI and SHI of UCA

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)

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Lantheus Medical Imaging

    collaborator INDUSTRY

  • University of California, San Diego

    collaborator OTHER

  • Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Flemming Forsberg, phD · Thomas Jefferson University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2019-04-05
Completion
2019-04-05

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01490892 on ClinicalTrials.gov