Device that extracts brain tumors gains FDA breakthrough status
- A device that aims to draw aggressive brain tumor cells to the exterior of the brain, where they can be collected and extracted, has received FDA's breakthrough designation, meaning the agency will expedite its review.
- Work on the device, dubbed the tumor monorail, is being conducted in the lab of Duke University Engineering Dean Ravi Bellamkonda, with funding from Ian's Friends Foundation, the National Cancer Institute's Eureka program, and the Marcus Foundation.
- The research group first demonstrated the effectiveness of the device in rats in 2014 and has since reproduced the results multiple times, according to Duke University. The researchers are now redesigning the device and working to prove that it is safe for human trials, with the aim of gaining FDA approval for those studies by the end this year.
The Duke team's prototype device targeted glioblastoma, one of the most aggressive types of cancer that begins in the brain. There is no cure for glioblastoma, which former presidential candidate and Senator John McCain died of last year.
Palliative treatment may include surgery, radiation therapy or chemotherapy.
The tumors have finger-like tentacles that infiltrate the brain, making it hard to remove them completely. The median age at diagnosis for glioblastoma is 64 years, and the median survival rate for adults is 11 to 15 months, according to the American Brain Tumor Association.
With Duke's prototype device, the spread of the tumors slowed, and they shrank by more than 90%.
In its latest version, the device consists of a thin catheter tube with a small reservoir at the end that rests on top of the skull under the scalp. The glioblastoma cells migrate to the external container, where they can then be collected and removed. The researchers said they are using a material that is known to last a long time and is well-tolerated in the human body, but noted the device could be made from a variety of materials.
The device replicates the structure of the brain's white matter where it travels through an opening between the left and right hemispheres that is a growth track for glioblastoma. There are no chemicals or enzymes involved. The earlier device used a toxic gel in the reservoir, but the researchers found that it played a secondary role.
"What's most important is that the tumor is spreading in a controlled way through our device to a reservoir, and away from the mother tumor, rather than through the healthy brain tissue," Nassir Mokarram, Duke biomedical engineering faculty member and leader of the project, said in a press release. "Simply by being far away from the mother tumor, the cells are more susceptible to dying anyway, and a neurosurgeon can access the reservoir to empty it when needed."
Barun Brahma, a neurosurgeon at Children's Healthcare of Atlanta, and member of the research team, said the device gives clinicians a minimalist approach to treating tumors considered inoperable due to their location or the frailty of the patient.
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