Protocol Title:

Spect Analysis of Cardiac Perfusion Changes After Whole Breast/Chest Wall Radiation Therapy with Active Breathing Coordinator

Protocol Status:

Open

Protocol Number:

J0609

Type of Cancer:

Breast

Principal Investigator:

Richard Zellars M.D.

Research Nurse:

Shirl DiPasquale, RN

Phase Number:

N/A

General Eligibility:

Prospective participants must be 18 and older, have had a segmental mastectomy or mastectomy as a result of left breast adenocarcinoma or ductal carcinoma.

Purpose:

Our researchers have developed technology that delivers radiation during deep inspiration only, Active Breathing Coordinator (ABC). During deep inspiration, the chest wall and breast move away from the heart. This increased distance should theoretically allow physicians to protect the coronary arteries and heart muscle from radiation exposure. Thus we propose to assess the efficacy of this new technology, ABC, to protect the heart by evaluating the change in cardiac muscle perfusion in women receiving radiation for breast cancer via a prospective randomized trial.

Treatment:

Subjects will be randomized to receive the ABC device or not during standard radiation treatment to the left breast. All subjects will receive 2 SPECT scans, one prior to treatment and the other 6 months after radiation treatment is complete. All subjects will be followed in a post study phase of the trial. The follow schedule is first at 6 months after the last radiation treatment is given, second is every 3-6 months thereafter up to the second year then every 4-6 months between the 3-5 year. Follow up visits end after the fifth year.