Radiation-related injuries to healthy tissue in the gastrointestinal tract frequently occur in patients being treated for cancer.
These injuries can cause painful sores and swelling in the mouth, throat and rectum, and interfere with normal eating and digestion. They can sometimes be so severe that the patient is forced delay or stop treatment.
Researchers from Massachusetts General Hospital, Brigham and Women’s Hospital, Dana-Farber Cancer Institute, and MIT are developing a new set of personalized, 3D printed, radioprotective devices that could vastly improve the protection of healthy tissues without compromising the effectiveness of the treatment.
The team, led by James Byrne, MD, PhD, and Giovanni Traverso, MB, BChir, PhD, recently published a feasibility study on the new devices in Advanced Science.
Gastroenterologists regularly see patients with injuries due to radiation toxicity, explains Byrne, a radiation oncologist affiliated with all four institutions. They can help patients manage the symptoms to get through treatment, but there’s a need for new ways to protect the injuries from happening in the first place.
While radioprotective shields and spacers are available, they are not easily customized to account for differences in patient anatomy and tumor location, making them impractical for clinical use.
“Patient anatomy varies considerably, as does the involvement of lymphatics, blood vessels and lymph nodes with the tumor depending on its stage and location,” says Byrne. “We have to make the devices very patient-specific.”
To overcome this challenge, the researchers used imaging data from pretreatment scans to generate 3D models of the organs at risk and custom-printed the protective devices to fit.
The devices are made from plastic to resemble mouthguards for patients with oral cancer and catheters for patients with lung or prostate cancer. They can then be filled with either a radioprotective substance–to protect healthy tissue–or saline to allow for pretreatment imaging and positioning.
In their feasibility study, the team found the devices were effective at reducing radiation-related injuries in lab models and would be easy to incorporate into existing clinical workflows.
In simulation studies of patients who had previously been treated for prostate and oral cancers, the team found that the devices could have reduced radiation doses to healthy tissue by 15% in prostate cancer patients and 30% in oral cancer patients.
The team also conducted a modeling study which found the devices would be a cost-effective alternative to the current standard-of-care. Additional cost savings would come from a reduction in the number of hospitalizations, emergency room visits and treatment interventions for radiation-related injuries, the team found.
More research will be needed before the devices can be translated into the clinic, but the team is optimistic they can move forward quickly and hopes to launch a clinical trial in oral cancer patients within the year.
“We’re encouraged by these results and aim to translate our findings to help patients minimize side effects from radiation therapy,” says Traverso, a gastroenterologist at BWH and assistant professor of mechanical engineering at MIT.
“It’s great to have the foundation in place,” adds Byrne. “Now we want to take the next steps to see if we can have a big impact on some of our cancer patients.”
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