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NCT Number: NCT02115607

Subharmonic Imaging and Pressure Estimation for Monitoring Neoadjuvant Chemotherapy

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.

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Perflutren Lipid Microspheres

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: 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.

  2. SHI Depiction of Breast Cancer Angiogenesis for Partial Responders

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Other

Collaborators

  • U.S. Army Medical Research and Development Command

Registry information

Official study title

Quantitative Subharmonic Breast Imaging: Subharmonic Imaging and Pressure Estimation for Monitoring Neoadjuvant Chemotherapy

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Apr 16, 2014
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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