Subharmonic Imaging and Pressure Estimation for Monitoring Neoadjuvant Chemotherapy

NCT02115607 | Completed Results DMC

• 2 other identifiers: 13S.215JT 2973
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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

Keywords

Breast cancer; Interstitial fluid pressure; Angiogenesis; Contrast enhanced ultrasound imaging; Subharmonic imaging; Subharmonic pressure estimation

Outcome Measures

Primary Outcomes (2)

• 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.

  from baseline to completion of neoadjuvant chemotherapy, average of 6 months

• 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.

  from baseline to completion of neoadjuvant chemotherapy

Secondary Outcomes (2)

• Subharmonic Imaging (SHI) Depiction of Breast Cancer Angiogenesis for Complete Responders

  From baseline to after surgery

• SHI Depiction of Breast Cancer Angiogenesis for Partial Responders

  After surgery; on average 6 months

Study Arms (1)

Definity infusion

EXPERIMENTAL

Infusion of Definity (Perflutren Lipid Microspheres)

Drug: Definity infusion

Interventions

Definity infusion DRUG

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

Also known as: Perflutren Lipid Microspheres

Definity infusion

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Thomas Jefferson University Hospital

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Flemming Forsberg, PhD
• Organization: Sidney Kimmel Cancer Center at Thomas Jefferson University

flemming.forsberg@jefferson.edu

215-955-4870

Study Officials

• Flemming Forsberg, PhD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: April 16, 2014
• Study Start: March 1, 2014
• Primary Completion: May 23, 2018
• Study Completion: May 23, 2018
• Last Updated: May 6, 2025
• Results First Posted: October 31, 2019

Record last verified: 2025-05

Locations

US (1)