Subharmonic Imaging and Pressure Estimation for Monitoring Neoadjuvant Chemotherapy

NCT ID: NCT02115607

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2018-05-23

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Definity infusion

Infusion of Definity (Perflutren Lipid Microspheres)

Group Type: EXPERIMENTAL

Definity infusion

Intervention Type: DRUG

3 ml of Perflutren Lipid Microspheres (Definity) mixed in 50 ml of saline is infused at a rate of approximately 4ml/min

Interventions

Definity infusion

3 ml of Perflutren Lipid Microspheres (Definity) mixed in 50 ml of saline is infused at a rate of approximately 4ml/min

Intervention Type: DRUG

Other Intervention Names

Perflutren Lipid Microspheres

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

U.S. Army Medical Research and Development Command

FED

Sponsor Role: collaborator

Sidney Kimmel Cancer Center at Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Flemming Forsberg, PhD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://hospitals.jefferson.edu/

Thomas Jefferson University Hospital

Other Identifiers

JT 2973

Identifier Type: OTHER

Identifier Source: secondary_id

13S.215

Identifier Type: -

Identifier Source: org_study_id