Protocol Summary

Protocol No.: OCR14962

Sponsor Protocol No.: BELLE

Study Title
BELLE: Early Markers of Subclinical Pulmonary Vascular Radiation Toxicity in Breast Cancer

Principal Investigator(s)
O'Dell, Walter

This study will use CT imaging, pulmonary function tests, and blood samples to examine the differences in pulmonary vessel radiation damage between patients treated with standard X-ray therapy and those treated with proton therapy.

Phase: NA

Age Group: Adult

Scope: Local

Detailed Eligibility
1. Ages 18 years old and older.
2. Breast cancer patients who have Stage II or higher disease and who are scheduled to receive conventional X-ray RT (n=30) or proton therapy (n=25) to the breast and chest wall for the treatment of breast cancer will be enrolled in this study.
3. Patients must sign informed consent meeting all federal and institutional guidelines prior to any radiation treatment and/or research interventions.

1. Patients not willing or able to submit to repeat chest CT scans with injected vascular contrast and blood draws at the Department of Radiology at UF Shands in Gainesville, or Shands Jacksonville Hospitals.
2. Pregnant women are excluded because of possible radiation risk to the fetus.
3. Patients who have previously had radiation treatment where any portion of the lung received greater than 5 Gy of radiation exposure.
4. Women with bilateral breast cancer or metastatic disease to sites near the chest where additional radiation exposure to any portion of the lung of greater than 5 Gy is anticipated.
5. Because breast cancer is rare in men, males are excluded.
6. Women with adverse reaction to all common CT contrast agents.

Applicable Disease Sites
Breast Cancer

Participating Institutions
UF Gainesville : John Lybarger
UF Jacksonville : John Lybarger

John Lybarger, MPH, CCRC
Phone: +1 352-265-0680 ext. 87829