RECRUITING

Contrast-Enhanced Ultrasound Scan for the Estimation of Tissue Pressure in Patients With Breast Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This clinical trial studies the use of contrast-enhanced ultrasound (CEUS) in estimating tissue pressure in patients with breast cancer. Diagnostic procedures, such as CEUS, may help estimate tissue pressure noninvasively.

Official Title

Interstitial Fluid Pressure Estimation in Breast Cancer Using 3D Subharmonic Signals From Contrast-Enhanced Ultrasound

Quick Facts

Study Start:2020-11-24

Study Completion:2025-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04721886

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Provide signed and dated informed consent form * Be conscious, willing and able to comply with all study procedures and be available for the duration of the study * At least 21 years old * Be scheduled for a breast biopsy (Breast Imaging Reporting and Data System \[BIRAD\] 4, 4A, 4B, 4C or 5) * Patient with an at least 1 cm mass located at \< 3 cm depth, approachable by 2.5 inch needle * Be medically stable as determined by the investigator * If a female of child-bearing potential, must have a negative urine pregnancy test within 24 hours prior to administration of Definity	* Females who are pregnant or nursing * Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example: * Patients on life support or in a critical care unit * Patients with unstable occlusive disease (e.g., crescendo angina) * Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia * Patients with uncontrolled congestive heart failure (New York Heart Association \[NYHA\] class IV) * Patients with recent cerebral hemorrhage * Patients who have undergone surgery within 24 hours prior to the study sonographic examination * Patients with known hypersensitivity or allergy to any component of Definity * Patients with unstable cardiopulmonary conditions or respiratory distress syndrome * Patients with uncontrollable emphysema, pulmonary vasculitis, pulmonary hypertension or a history of pulmonary emboli

Inclusion Criteria

Exclusion Criteria

* Provide signed and dated informed consent form
* Be conscious, willing and able to comply with all study procedures and be available for the duration of the study
* At least 21 years old
* Be scheduled for a breast biopsy (Breast Imaging Reporting and Data System \[BIRAD\] 4, 4A, 4B, 4C or 5)
* Patient with an at least 1 cm mass located at \< 3 cm depth, approachable by 2.5 inch needle
* Be medically stable as determined by the investigator
* If a female of child-bearing potential, must have a negative urine pregnancy test within 24 hours prior to administration of Definity

* Females who are pregnant or nursing
* Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:
* Patients on life support or in a critical care unit
* Patients with unstable occlusive disease (e.g., crescendo angina)
* Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia
* Patients with uncontrolled congestive heart failure (New York Heart Association \[NYHA\] class IV)
* Patients with recent cerebral hemorrhage
* Patients who have undergone surgery within 24 hours prior to the study sonographic examination
* Patients with known hypersensitivity or allergy to any component of Definity
* Patients with unstable cardiopulmonary conditions or respiratory distress syndrome
* Patients with uncontrollable emphysema, pulmonary vasculitis, pulmonary hypertension or a history of pulmonary emboli

Contacts and Locations

Study Contact

Kibo Nam, MD

CONTACT

215-955-6261

Kibo.Nam@jefferson.edu

Study Locations (Sites)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107

United States

Collaborators and Investigators

Sponsor: Thomas Jefferson University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-24

Study Completion Date2025-01-01

Study Record Updates

Study Start Date2020-11-24

Study Completion Date2025-01-01

Terms related to this study

Additional Relevant MeSH Terms

Breast Carcinoma