Subharmonic Imaging and Pressure Estimation for Monitoring Neoadjuvant Chemotherapy

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status: Completed

Conditions: Breast Cancer

Treatments: Drug: Definity infusion

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02115607

JT 2973 (Other Identifier)

13S.215

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: Female

Ages: 21+ years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Definity infusion

Experimental group

Description:

Infusion of Definity (Perflutren Lipid Microspheres)

Treatment:

Drug: Definity infusion