With a 5-year survival rate as low as 5%, pancreatic cancer is among the most deadly cancers in the US. Despite advancements in treatment, surgical removal of the tumor via an intensive surgery, known as the Whipple procedure or pancreaticoduodenectomy, remains the only curative option. However, even after this complex surgery, cancer recurs within 1-2 years for 80% of patients, with roughly 1 in 3 cases recurring exclusively at the surgical margin (anatomic tissue from where the original tumor was cut). Once the cancer recurs, patient life expectancy drops to 9 months. Research has shown that intraoperative radiation therapy (IORT) (i.e. delivering radiation to the margins of the exposed resection bed just after the tumor is removed) decreases the rate of local recurrence in many different cancers. However, at high-volume hospitals like JHH, where pancreatic resections are typically performed, IORT is not commonly used for pancreatic cancer. The primary reason for this is that existing radiation applicators are not designed to conform to the treatment volume and thus do not adequately treat the margin of the tumor.

β-Trace is a novel IORT technology that can dramatically alter outcomes in surgically resectable pancreatic cancers using a patient-customized IORT planning system and applicator that delivers ablative radiation during the Whipple procedure to the entirety of the resection bed effectively killing residual tumor cells and significantly decreasing the chance of local recurrence. Our critical technical insight revolves around creating a volumetric treatment applicator while leveraging the proven radiation delivery methodology. Existing applicators for IORT treatments are composed of interconnected plastic spheres, which house a web of catheters. A radiation seed, such as Iridium-192 (IR-192), is transported through the catheter system by an automated system (afterloader). The duration the seed spends in each catheter determines the total dosage delivered to a body structure. This technology is crucial for the delivery of high dose radiation to the resection bed while remaining affordable for hospital systems. However, a glaring inadequacy of the existing technology is its inability to deliver a radiation dose to a complex volume. Current applicators cannot be formed into a 3D shape and a volumetric radiation dose cannot be calculated, meaning treatment can only be done for flat areas.

β-Trace aims to model the clinician-identified target volume using a patient’s CT scans taken 4-6 weeks preoperatively. This simulated model enables β-Trace to construct the second component of our platform, which consists of an applicator optimized for each patient’s anatomy. β-Trace determines the ideal catheter channel positioning in three dimensions in relation to the patient’s vasculature and resection volume. After catheter placement is chosen, the patient customized applicator is made, a mold based on the simulated design is 3D printed and filled with medical-grade silicone. The resulting device is a soft, flexible, volumetric applicator capable of interfacing with already existing afterloading systems in hospitals, requiring low capital investment and remaining easily compatible with existing clinical workflow. β-Trace system optimizes applicator design to fit each patient’s anatomy and thus significantly improves IORT delivery compared to current IORT standards in the pancreatic cancer space.

Team Members

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Project Mentors, Sponsors, and Partners

• Dr. Jin He, MD, PhD

• Dr. Richard Burkhart, MD

• Dr. Robert Hobbs, PhD

• Dr. Kunal Parikh, PhD

• Dr. Bruce Forsyth, PhD

• Dr. Amol Narang, MD

• Dr. Youseph Yazdi, PhD

Course Faculty

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Project Links

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Additional Project Information