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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Device :DaRT seeds
DeviceThe sources are impregnated with a layer containing Ra-224 which is well fixated to the surface of the source. Ra-224 undergoes a series of decay events with each daughter product producing an alpha particle
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Experimental: DaRT seedsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility - DaRT seed placement
Feasibility will be determined according to the rate of successful placement of Alpha DaRT sources into brain tumors.
Time frame
From day 0 until 12 months2
Safety - Adverse events
Safety will be determined according to incidence of acute grade 3 or greater unanticipated Adverse Events (AE) according to CTCAE v5.0 criteria
Time frame
From day 0 until 12 monthsSecondary outcomes
1
Toxicity profile
according to CTCAE v5.0
Time frame
within 4 weeks of completion of postoperative radiotherapy2
Radiographic local tumor control
per RANO criteria
Time frame
from 1 month following surgery and onwards3
Rate of pseudo-progression at first post-implant scan
RANO criteria
Time frame
1 month following surgery4
Overall survival
Time frame
up to 12 months post implantSponsors and contacts
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Source ClinicalTrials.gov