Subharmonic Imaging and Pressure Estimation for Monitoring Neoadjuvant Chemotherapy

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Definity infusion

• Registration Number: NCT02115607
• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-24
• Study First Submitted QC: 2014-04-14
• Study First Posted: 2014-04-16
• Primary Completion: 2018-05-23
• Study Completion: 2018-05-23
• Results First Submitted: 2019-09-10
• Results First Submitted QC: 2019-10-07
• Results First Posted: 2019-10-31
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-22
• Last Update Posted: 2019-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 17

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Definity infusion	Definity infusion	Infusion of Definity (Perflutren Lipid Microspheres)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
SHI Depiction of Breast Cancer Angiogenesis for Partial Responders	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.
Subharmonic Imaging (SHI) Depiction of Breast Cancer Angiogenesis for Complete Responders	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.

Trial Locations

Locations (1)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States