Protocol Title:

Ultrasound Based Localization of Lumpectomy Bed in Anatomical Coordinate System

Protocol Status:

Open

Protocol Number:

J-0728

Type of Cancer:

Breast Cancer

Principal Investigator:

Richard Zellars, M.D.

Research Nurse:

Shirl DiPasquale, R.N.

Phase Number:

Assessment Study

General Eligibility:

Women who are 18 years of age or older with breast cancer. Must have had a lumpectomy. Must be scheduled to have radiation therapy.

Purpose:

Aim 1:
Describe the concordance between the lumpectomy bed’s centerof- mass (COM) as determined by USEI and CT.

Aim 2:
Describe the concordance between the lumpectomy bed volume as measured by USEI and CT.

Treatment:

This is a prospective, pilot study. The main objectives are to determine the correlation between lumpectomy volume and position as measured by USEI with the same as measured by CT. This is not a study to determine the superiority of USEI over current methods for daily radiation therapy positioning. The only study procedure involved in this project is for subjects to undergo an ultrasound scan during their radiation therapy simulation. The ultrasound is done at this time, so it can be co-registered to the routine breast treatment planning CT scan. In order to assist the sonographer in the task of holding the ultrasound transducer on the breast in the optimal position, we may in some cases apply an articulated passive mechanical arm that fully complies with the sonographer’s motion and can hold the ultrasound transducer in the desired pose. A similar arm is used in the FDA-approved BAT system that we use at Johns Hopkins to acquire a pelvic ultrasound scan from every prostate cancer patient before the delivery of each radiotherapy fraction. We propose to fabricate a functionally similar arm and use it in the proposed CT/US data collection system. The breast ultrasound scanning is expected to take about 15 minutes. Again, the information that is collected from the ultrasound will not be used for the clinical management of the patient. We have chosen breast cancer patients who are going to undergo radiation therapy because they are going to have a CT of the breast.