search
Back to results

Subharmonic Imaging and Pressure Estimation for Monitoring Neoadjuvant Chemotherapy

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Definity infusion
Sponsored by
Sidney Kimmel Cancer Center at Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Breast cancer, Interstitial fluid pressure, Angiogenesis, Contrast enhanced ultrasound imaging, Subharmonic imaging, Subharmonic pressure estimation

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Thomas Jefferson University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Definity infusion

Arm Description

Infusion of Definity (Perflutren Lipid Microspheres)

Outcomes

Primary Outcome Measures

Subharmonic Aided Pressure Estimation (SHAPE) After Treatment for Complete Responders
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.
Subharmonic Aided Pressure Estimation (SHAPE) After Treatment for Partial Responders
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.

Secondary Outcome Measures

Subharmonic Imaging (SHI) Depiction of Breast Cancer Angiogenesis for Complete Responders
To compare the 3D Subharmonic imaging (SHI) depiction of breast cancer angiogenesis in humans to CD31, an immunohistochemical predictor of angiogenesis.
SHI Depiction of Breast Cancer Angiogenesis for Partial Responders
To compare the 3D SHI depiction of breast cancer angiogenesis in humans to CD31, an immunohistochemical predictor of angiogenesis.

Full Information

First Posted
March 24, 2014
Last Updated
November 22, 2019
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
U.S. Army Medical Research and Development Command
search

1. Study Identification

Unique Protocol Identification Number
NCT02115607
Brief Title
Subharmonic Imaging and Pressure Estimation for Monitoring Neoadjuvant Chemotherapy
Official Title
Quantitative Subharmonic Breast Imaging: Subharmonic Imaging and Pressure Estimation for Monitoring Neoadjuvant Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
May 23, 2018 (Actual)
Study Completion Date
May 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
U.S. Army Medical Research and Development Command

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, Interstitial fluid pressure, Angiogenesis, Contrast enhanced ultrasound imaging, Subharmonic imaging, Subharmonic pressure estimation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Definity infusion
Arm Type
Experimental
Arm Description
Infusion of Definity (Perflutren Lipid Microspheres)
Intervention Type
Drug
Intervention Name(s)
Definity infusion
Other Intervention Name(s)
Perflutren Lipid Microspheres
Intervention Description
3 ml of Perflutren Lipid Microspheres (Definity) mixed in 50 ml of saline is infused at a rate of approximately 4ml/min
Primary Outcome Measure Information:
Title
Subharmonic Aided Pressure Estimation (SHAPE) After Treatment for Complete Responders
Description
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.
Time Frame
from baseline to completion of neoadjuvant chemotherapy, average of 6 months
Title
Subharmonic Aided Pressure Estimation (SHAPE) After Treatment for Partial Responders
Description
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.
Time Frame
from baseline to completion of neoadjuvant chemotherapy
Secondary Outcome Measure Information:
Title
Subharmonic Imaging (SHI) Depiction of Breast Cancer Angiogenesis for Complete Responders
Description
To compare the 3D Subharmonic imaging (SHI) depiction of breast cancer angiogenesis in humans to CD31, an immunohistochemical predictor of angiogenesis.
Time Frame
From baseline to after surgery
Title
SHI Depiction of Breast Cancer Angiogenesis for Partial Responders
Description
To compare the 3D SHI depiction of breast cancer angiogenesis in humans to CD31, an immunohistochemical predictor of angiogenesis.
Time Frame
After surgery; on average 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flemming Forsberg, PhD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Links:
URL
http://hospitals.jefferson.edu/
Description
Thomas Jefferson University Hospital

Learn more about this trial

Subharmonic Imaging and Pressure Estimation for Monitoring Neoadjuvant Chemotherapy

We'll reach out to this number within 24 hrs