Monitoring Neoadjuvant Chemotherapy of Breast Cancer Using 3D Subharmonic Aided Pressure Estimation

Overview

About this study

The purpose of this trial is to determine if a special kind of ultrasound, called contrast-enhanced ultrasound, an experimental imaging test, can detect pressures in cancer to determine the response to neoadjuvant chemotherapy in patients with breast cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Provide signed and dated informed consent form

- Willing to comply with all study procedures and be available for the duration of the
study

- At least 21 years old

- Be diagnosed with breast cancer (T1 or greater LABC, any N and M0)

- Be scheduled for neoadjuvant chemotherapy

- Be medically stable

- Be conscious and able to comply with study procedures

- If a female of child-bearing potential, must have a negative urine pregnancy test

Exclusion Criteria:

- Females who are pregnant or nursing

- Patients with other primary cancers requiring systemic treatment

- Patients with any distal metastatic disease

- Patients undergoing neoadjuvant endocrine therapy

- 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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/6/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Jaydev Dave, Ph.D.

Contact us for the latest status

Contact information:

Fatima Zohra

Zohra.Fatima@mayo.edu

More information

Publications

Publications are currently not available
.
CLS-20573496

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