SBIR-STTR Award

The use of LDR brachytherapy after sub-lobar lung resection is the focus of a phase III NCI sponsored trial. Early clinical results from independent studies suggest that brachytherapy enables a singificant reduction in local recurrence rates versus surgery alone. Civatech Oncology and Allegheny General Hospital propose to design and fabricate a bio-absorbable, 2-dimensional sheet brachytherapy source to replace the current ad hoc method of sewing brachytherapy seeds to mesh. The new device will have a more uniform radiation profile, will allow for cutting to appropriately size the implant sheet and will be essentially uni-directional in terms of x-ray emissions. The latter point is important both in terms of minimizing radiation exposure to physicians and staff, but more particularly greatly reduces the dose to collateral normal tissues since the radiation from the sheet will impact the target lung tissue only. This new 2-dimensional device draws from the same fabrication methodology used by Civatech oncology to produce a novel linear LDR source for prostate cancer, device that has achieved FDA clearance. Other applications for the 2-D device will be evaluated, such as for sparing normal bowel in retroperitoneal and pelvic targets in regions of close margins or limited residual disease.

NIH Spending Category:
Bioengineering; Cancer

Project Terms:
Biocompatible Materials; Biological; Brachytherapy; Brachytherapy Seeds; Clinical; Containment; design; Devices; Dose; Ensure; Equilibrium; Evaluation; Excision; Exposure to; General Hospitals; Half-Life; Implant; Intestines; Lobar; Lung; Malignant neoplasm of prostate; Measurement; Methodology; Methods; Modeling; Normal tissue morphology; novel; Nylons; oncology; Operative Surgical Procedures; Pelvis; Phase; Physicians; Radiation; Recurrence; Residual Tumors; Retroperitoneal Space; Sampling; seal; Source; Structure of parenchyma of lung; two-dimensional; Validation; Vicryl

According to the American Cancer Society 220,000 men and women in the U.S. develop lung and bronchial cancer every year and 147,000 die of the disease. Of lung cancer patients, 85% present with non-small-cell lung cancer and 16.7% of these will present with localized disease. Note that lung cancer is very difficult to treat. The five year survival for localized disease is 52%, the five year survival for more advanced disease is less than 24%. At present, brachytherapy devices used for lung cancer treatmentconsist of metal I-125 or Cs-131 seeds, originally designed for prostate cancer, sewn to a bio-absorbable vicryl mesh. The device is not optimal for treating lung cancer. The device emits radiation in all directions and delivers radiation to otherwise healthy tissue. It is cumbersome to handle and difficult to shape to the patient s anatomy. Lung tumors are often located near critical structures sensitive to radiation exposure. Approximately 20% of patients who otherwise could be treated with lung brachytherapy are either not treated or prescribed alternative treatments due to the risk of radiation exposure to the arteries, nerves, the heart, the chest wall, the skin, and in female patients, the breasts. Those patients who are treated with the existing device are exposed to unnecessary radiation dose. CivaTech developed, with partial support from a Phase I SBIR contract from the National Cancer Institute, a prototype brachytherapy device specifically designed for lung cancer treatment that directions radiation therapy to diseased tissue only. This device, called the CivaSheet, is planar, uni-directional and partially bio-absorbable. CivaTech is seeking Phase II support to develop the prototype into a clinic ready device.