Clinical trial NCT02115607: Subharmonic Imaging and Pressure Estimation for Monitoring Neoadjuvant Chemotherapy
Official title: Quantitative Subharmonic Breast Imaging: Subharmonic Imaging and Pressure Estimation for Monitoring Neoadjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
Interstitial fluid pressure
Angiogenesis
Contrast enhanced ultrasound imaging
Subharmonic imaging
Subharmonic pressure estimation
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
First posted: 2014-04-16
Enrollment: 17
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Subharmonic Aided Pressure Estimation (SHAPE) After Treatment for Complete Responders
timeFrame: from baseline to completion of neoadjuvant chemotherapy, average of 6 months
measure: Subharmonic Aided Pressure Estimation (SHAPE) After Treatment for Partial Responders
timeFrame: from baseline to completion of neoadjuvant chemotherapy
Secondary outcomes:
measure: Subharmonic Imaging (SHI) Depiction of Breast Cancer Angiogenesis for Complete Responders
timeFrame: From baseline to after surgery
measure: SHI Depiction of Breast Cancer Angiogenesis for Partial Responders
timeFrame: After surgery; on average 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Flemming Forsberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: