Alpha Radiation Emitters Device (DaRT) for the Treatment of Recurrent Glioblastoma

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorAlpha Tau Medical LTD.

About this trial

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for the treatment of recurrent Glioblastoma

Eligibility criteria

Qualifiers

Males and females ≥ 18 and ≤ 85 years of age

Patients must have histologically confirmed diagnosis of WHO grade IV glioblastoma (including variants such as gliosarcoma, giant cell glioblastoma).

Single, gadolinium-enhancing tumor recurrence ≤ 3cm in maximum diameter

Patient not amenable for surgical resection due to any of the following but not limited reasons: patient refusal, medically ineligible, surgically too high risk due to tumor location in a deep and/or eloquent location.

Disqualifiers

Medical contraindication to MRI (cardiac devices are allowed if MRI compatible)

More than 3 relapses per RANO criteria

Acquired and or genetic clinical bleeding tendency

Suspicious of infratentorial or leptomeningeal or intraventricular disease

Trial design

Treatments tested in this trial

  • Device :DaRT seeds

Treatment groups

10 Participants
are divided into 1 treatment group

Locations

3
Honor Health85260, ScottsdaleArizona, United States
NYU Langone Health10016, New YorkNew York, United States
Ohio State University Medical Center43210, ColumbusOhio, United States

Sponsors and collaborators

Alpha Tau Medical LTD.

Lead sponsor