Subharmonic Imaging and Pressure Estimation for Monitoring Neoadjuvant Chemotherapy

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02115607
• Other study ID #: 13S.215
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: May 23, 2018

Study information

• Verified date: November 2019
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 23, 2018
• Est. primary completion date: May 23, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University	U.S. Army Medical Research and Development Command

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Subharmonic Imaging (SHI) Depiction of Breast Cancer Angiogenesis for Complete Responders	To compare the 3D Subharmonic imaging (SHI) depiction of breast cancer angiogenesis in humans to CD31, an immunohistochemical predictor of angiogenesis.	From baseline to after surgery
Secondary	SHI Depiction of Breast Cancer Angiogenesis for Partial Responders	To compare the 3D SHI depiction of breast cancer angiogenesis in humans to CD31, an immunohistochemical predictor of angiogenesis.	After surgery; on average 6 months

External Links

•   Sidney Kimmel Cancer Center at Thomas Jefferson University
•   Thomas Jefferson University Hospital