Subharmonic Imaging and Pressure Estimation for Monitoring Neoadjuvant Chemotherapy

November 22, 2019 updated by: Sidney Kimmel Cancer Center at Thomas Jefferson University

Quantitative Subharmonic Breast Imaging: Subharmonic Imaging and Pressure Estimation for Monitoring Neoadjuvant Chemotherapy

This is a diagnostic accuracy study to evaluate if two novel ultrasound (US) techniques, quantitative 3D subharmonic imaging (SHI) and Subharmonic Aided Pressure Estimation (SHAPE), used with an intravenous ultrasound contrast agent (Definity, Lantheus Medical Imaging, Billerica, MA), can track changes in locally advanced breast cancer (LABC) angiogenesis and interstitial fluid pressure (IFP), respectively, by studying women undergoing neoadjuvant chemotherapy before as well as with around 10% and 60% (in part 1) or 30% (in part 2) of the neoadjuvant chemotherapy treatment delivered and after completion of the neoadjuvant chemotherapy treatment. Results will be compared to MRI and pathology.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Females
  • Be diagnosed with T1 or greater LABC, any N and M0.
  • Be scheduled for neoadjuvant chemotherapy
  • Be at least 21 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 with other primary cancers requiring systemic treatment.
  • Patients with any metastatic disease.
  • Patients undergoing neoadjuvant endocrine therapy.
  • Patients with known hypersensitivity or allergy to any component of Definity.
  • Patients with cardiac shunts or congenital heart defects.
  • Patients with unstable cardiopulmonary conditions or respiratory distress syndrome.
  • Patients with uncontrollable emphysema, pulmonary vasculitis, pulmonary hypertension or a history of pulmonary emboli.
  • Patients who have received any contrast medium (X-ray, MRI, CT or US) in the 24 hours prior to the research US exam.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Definity infusion
Infusion of Definity (Perflutren Lipid Microspheres)
Drug: Definity infusion
3 ml of Perflutren Lipid Microspheres (Definity) mixed in 50 ml of saline is infused at a rate of approximately 4ml/min
Other Names:
  • Perflutren Lipid Microspheres

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subharmonic Aided Pressure Estimation (SHAPE) After Treatment for Complete Responders
Time Frame: from baseline to completion of neoadjuvant chemotherapy, average of 6 months
To evaluate the ability of SHAPE, used with Definity, to track changes in interstitial fluid pressure (IFP) by studying women undergoing neoadjuvant chemotherapy before as well as with around 10% and 30% of the neoadjuvant chemotherapy treatment delivered and comparing results to MRI and pathology.
from baseline to completion of neoadjuvant chemotherapy, average of 6 months
Subharmonic Aided Pressure Estimation (SHAPE) After Treatment for Partial Responders
Time Frame: from baseline to completion of neoadjuvant chemotherapy
To evaluate the ability of SHAPE, used with Definity, to track changes in interstititial fluid (IFP) by studying women undergoing neoadjuvant chemotherapy before as well as with around 10% 30% of the neoadjuvant chemotherapy treatment delivered and after completion of the neoadjuvant chemotherapy treatment and comparing results to MRI and pathology.
from baseline to completion of neoadjuvant chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subharmonic Imaging (SHI) Depiction of Breast Cancer Angiogenesis for Complete Responders
Time Frame: From baseline to after surgery
To compare the 3D Subharmonic imaging (SHI) depiction of breast cancer angiogenesis in humans to CD31, an immunohistochemical predictor of angiogenesis.
From baseline to after surgery
SHI Depiction of Breast Cancer Angiogenesis for Partial Responders
Time Frame: After surgery; on average 6 months
To compare the 3D SHI depiction of breast cancer angiogenesis in humans to CD31, an immunohistochemical predictor of angiogenesis.
After surgery; on average 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Collaborators

U.S. Army Medical Research and Development Command

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

May 23, 2018

Study Completion (Actual)

May 23, 2018

Study Registration Dates

First Submitted

March 24, 2014

First Submitted That Met QC Criteria

April 14, 2014

First Posted (Estimate)

April 16, 2014

Study Record Updates

Last Update Posted (Actual)

December 4, 2019

Last Update Submitted That Met QC Criteria

November 22, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13S.215

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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