Breast Cancer Lung Late Effects (BELLE)

Purpose

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.

Study details

This project involves repeat chest computed tomography (CT) imaging and blood draws in subjects with breast cancer with radiation treatment to the affected breast and chest wall. The investigators are studying women receiving one of 2 types of radiation, either conventional X-rays (IMRT) or protons at the University of Florida Health Proton Therapy Institute (UFHPTI).

These subjects typically would not receive follow-up chest CTs as per standard of care. All subjects will have received a pre-treatment chest CT scan as part of the treatment planning process. The investigators will enroll 30 subjects in the X-ray treatment group and 25 subjects in the proton group.

The investigative team has recently solved the technical challenges of extracting and characterizing lung vascular anatomy from clinical CT images of the chest and used these tools to characterize acute and chronic changes to pulmonary vascular structure in breast cancer patients receiving radiation to the chest wall for treatment of their cancer.

Eligibility

Inclusion criteria:

  • Ages 18 years old and older.
  • 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.
  • Patients must sign informed consent meeting all federal and institutional guidelines prior to any radiation treatment and/or research interventions.

Exclusion criteria:

  • 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.
  • Pregnant women are excluded because of possible radiation risk to the fetus.
  • Patients who have previously had radiation treatment where any portion of the lung received greater than 5 Gy of radiation exposure.
  • 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.
  • Because breast cancer is rare in men, males are excluded.
  • Women with adverse reaction to all common CT contrast agents.

Contact

For additional study information, please contact John Lybarger:

Age

18 to 65
65 and over

Gender

Female

Keywords

Breast Cancer, Radiation Toxicity, CT chest scans, clinical pulmonary toxicity, Breast diseases; Neoplasms; Skin Diseases

Principal Investigator

Walter O'Dell

Sponsoring Group

Department of Radiation Oncology

Contact Information

lybarj@shands.ufl.edu

352-265-0680 ext. 87829


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