1st trial participant receives Alpha DaRT radiation therapy for glioblastoma
New approach surgically implants radioactive source directly into tumor
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The first participant has been dosed in an early clinical trial testing the experimental radiation therapy Alpha DaRT in people with hard-to-treat glioma.
The clinical trial (NCT06910306), sponsored by Alpha DaRT’s developer, Alpha Tau Medical, is expected to enroll 10 adults with glioblastoma, an especially aggressive type of glioma. The study is open to patients who have already undergone a course of central nervous system radiation using traditional methods, and whose tumors cannot be removed surgically. Patients are being recruited at the Ohio State University Medical Center in Ohio, which is where the first participant was dosed.
“This achievement represents the culmination of many years of dedicated teamwork within Alpha Tau — including extensive preclinical research, developing a unique delivery system designed specifically to integrate seamlessly into a standard neurosurgical workflow and, of course, partnership with our wonderful clinical collaborators at OSU,” Robert Den, MD, chief medical officer of Alpha Tau, said in a company press release. “This is a transformational patient-centric moment of great scientific and clinical significance for the entire field of neuro-oncology.”
Method aimed at targeting tumor cells while sparing healthy ones
Radiation has for decades been a staple of treatment for gliomas and many other types of cancer. High-energy radiation waves can cause damage to cells’ DNA, and rapidly dividing cancer cells are especially sensitive to this damage.
Traditional radiation therapy setups use a machine outside the body that delivers a beam of radiation targeted at the tumor. Alpha DaRT — which is short for Diffusing Alpha-emitters Radiation Therapy — uses a different approach where a radioactive source is surgically implanted directly into a tumor. The source is specifically designed to emit radiation only a short distance, with the goal of delivering radiation directly to tumor cells while sparing healthy cells.
The main goals of the ongoing clinical trial are to test the feasibility and safety of this approach. The first implantation of Alpha DaRT was performed by a clinical team led by Joshua D. Palmer, MD, a radiation oncologist who is serving as principal investigator for the trial.
“Patients with recurrent glioblastoma face one of the most difficult cancer diagnoses in medicine. There is an urgent unmet need for new therapeutic approaches that can be delivered locally while minimizing harm to surrounding healthy brain tissue,” Palmer said. He added that therapies like Alpha DaRT that aim to deliver radiation directly into the tumor “offer a highly compelling novel scientific approach by delivering potent, short-range radiation precisely where it is needed most.”
J. Bradley Elder, MD, a neurosurgeon who assisted with implantation, noted that the procedure “demonstrated excellent feasibility,” adding that the system used to help implant the device “integrates seamlessly as an add-on to the standard brain navigation platform that I use routinely in surgery, making it simple to adopt without disrupting existing workflow.”
