Recurrent GlioblastomaNCT06910306
Alpha Radiation Emitters Device (DaRT) for the Treatment of Recurrent Glioblastoma
A study testing Device :DaRT seeds in people with Recurrent Glioblastoma and Recurrent Gliomas, run by Alpha Tau Medical LTD. at 3 sites in United States.
Trial summary
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for the treatment of recurrent Glioblastoma Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Recurrent Glioblastoma, Recurrent Gliomas
- What is being tested?
- Device :DaRT seeds
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Oct 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Prior history of central nervous system (CNS) radiation (standard dose) with 50.4-60 Gy delivered in 1.8 Gy-2.0 Gy fractions with concurrent temozolomide (if the patient has received a non-standard fractionation or radiation dose, such as 40 Gy in 15 fractions.
- Patients must have a time interval ≥4 months between completion of prior radiation and trial registration and have tumor progression per RANO criteria
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- Patients must have a measurable disease per RANO criteria
- Estimated life expectancy is more than 6 months
- Target lesion amenable for coverage by the DaRT sources
- Patient must either have had recent subtotal surgery/biopsy following tumor recurrence (at least 6 weeks from trial registration) or must have shown unequivocal radiographic evidence for tumor progression by contrast-enhanced MRI scan within 21 days prior to trial registration. If surgery was performed, must have a post-operative MRI scan within 21 days prior to trial registration.
- Patients have recovered from prior therapy side effects and must be at least 4 weeks post administration of chemotherapies or investigational agents with the exception of nitrosureas (such as Carmustine, Fotemustine, Lomustine) which requires 42 days of washout.
- Karnofsky performance score (KPS) of at least 60 documented within 14 days prior to trial registration
- Patients must have adequate biological parameters as demonstrated by the following blood counts at initial screening obtained ≤ 14 days prior to starting treatment Absolute neutrophil count (ANC) ≥ 1.5 × 109/L Platelet count ≥ 100,000/mm3 (80 × 109/L) Hemoglobin (Hgb) ≥ 9 g/dL.
- Patients must have the following blood chemistry levels at initial screening obtained ≤ 14 days prior to starting treatment AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal range (ULN) Total bilirubin ≤ 1.5 × ULN
- Effective contraception must be used by both male and female patients while on the study and for up to 3 months following treatment
- Patient must have been informed about the nature of the study, and must have agreed to participate in the study, and signed the Informed Consent Form (ICF) prior to participation in any study-related activities
Who cannot join
- 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
- Concomitant chemotherapy or any other systemic therapy not allowed in the protocol
- Recent or current (within 6 weeks) therapy with VEF or a VEGFR inhibitor
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- Immunocompromised state due to either transplant or AIDS
- Prior allergic reaction to the study drugs
- History of hypertensive crisis or hypertensive encephalopathy
- Uncontrolled hypertension (defined as either \>150 mm/Hg for systolic and \>90mm/Hg for diastolic)
- History of a non-healing wound, ulcer, gastrointestinal bleed (\> grade 3), traumatic injury, or bone fracture within 90 days prior to registration Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT
- High probability of protocol non-compliance (in opinion of investigator)
- Pregnancy or lactation
- Collagenous diseases, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Ohio State University Medical Center
Columbus, Ohio, 43210
Joshua Palmer, MD, 917-601-3414, joshua.palmer@osumc.edu
- Recruiting
NYU Langone Health
New York, New York, 10016
Daniel Orringer, MD, 734-709-2196, daniel.orringer@nyulangone.org
Teresa Russell, 212-263-5035, Teresa.Russell@nyulangone.org
- Recruiting
Honor Health
Scottsdale, Arizona, 85260
John Wanebo, MD, 480-583-0192, john.wanebo@barrowbrainandspine.com
Claudia Crroks, MS, 480-583-0192, ccrooks@honorhealth.com
About this study
Official title: A Study to Assess the Feasibility and Safety of Intratumoral Diffusing Alpha Emitters for the Treatment of Recurrent Glioblastoma
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for the treatment of recurrent Glioblastoma
Read the detailed description
This is a Prospective Open label Single arm Multi-center interventional study. The study is designed to evaluate the Feasibility and Safety of DaRT seeds for the treatment of recurrent Glioblastoma.
A total of 10 subjects will be enrolled.
Eligible patients who meet inclusion/exclusion criteria (as assessed during the screening period) will be invited to the site for the procedure of DaRT seeds insertion and will return for a follow up visit every 2 months (+/- 7 days ) up to 12 months (4 ,6 , 8, 10 and 12 ). Survival F.U (after visit 11) will be done via phone calls every 2-3 months until (1) the start of new anti-cancer treatment, (2) disease progression or (3) death, whichever occurs first.
- Conditions
- Recurrent Glioblastoma, Recurrent Gliomas
- Being tested
- Device :DaRT seeds
- Keywords
- Recurrent Glioblastoma, Brachytherapy, GBM, Alpha DaRT sources, Intratumoral Diffusing Alpha Emitters
- Medical subject headings
- Glioblastoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device :DaRT seedsDevice
The 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
| Study group | Role | What they receive |
|---|---|---|
| Experimental: DaRT seeds | Experimental | DaRT sources are inserted into the tumor according to a pre determined plan. The delivery of the DaRT Sources into the tumor is done by using a designated Alpha DaRT Applicator . Receives: Device: Device :DaRT seeds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - DaRT seed placement
Feasibility will be determined according to the rate of successful placement of Alpha DaRT sources into brain tumors.
Measured: From day 0 until 12 months
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
Measured: From day 0 until 12 months
Secondary outcomes (4)
Toxicity profile
according to CTCAE v5.0
Measured: within 4 weeks of completion of postoperative radiotherapy
Radiographic local tumor control
per RANO criteria
Measured: from 1 month following surgery and onwards
Rate of pseudo-progression at first post-implant scan
RANO criteria
Measured: 1 month following surgery
Overall survival
Measured: up to 12 months post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start1 Oct 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent GlioblastomaStudies of the same condition, open and under way.
- More trials run by Alpha Tau Medical LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective , Multicenter , Open label, Single arm with DaRT for the treatment of Recurrent Glioblstoma .
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alpha Tau Medical LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910306
- Sponsor's protocol ID
- CTP-GBM-01
- Status last verified
- Sep 2025
- First submitted
- 23 Sep 2024
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Feasibility and Safety of Intratumoral Diffusing Alpha Emitters for the Treatment of Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT06910306
- Acronym / sponsor ID
- CTP-GBM-01
- Conditions
- Recurrent Glioblastoma, Recurrent Gliomas
- Keywords
- Recurrent Glioblastoma, Brachytherapy, GBM, Alpha DaRT sources, Intratumoral Diffusing Alpha Emitters
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Alpha Tau Medical LTD.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for the treatment of recurrent Glioblastoma
Detailed description
This is a Prospective Open label Single arm Multi-center interventional study. The study is designed to evaluate the Feasibility and Safety of DaRT seeds for the treatment of recurrent Glioblastoma.
A total of 10 subjects will be enrolled.
Eligible patients who meet inclusion/exclusion criteria (as assessed during the screening period) will be invited to the site for the procedure of DaRT seeds insertion and will return for a follow up visit every 2 months (+/- 7 days ) up to 12 months (4 ,6 , 8, 10 and 12 ). Survival F.U (after visit 11) will be done via phone calls every 2-3 months until (1) the start of new anti-cancer treatment, (2) disease progression or (3) death, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective , Multicenter , Open label, Single arm with DaRT for the treatment of Recurrent Glioblstoma .
| Arm | Type | Receives |
|---|---|---|
| Experimental: DaRT seeds | Experimental | Device: Device :DaRT seedsDaRT sources are inserted into the tumor according to a pre determined plan. The delivery of the DaRT Sources into the tumor is done by using a designated Alpha DaRT Applicator . |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
- Prior history of central nervous system (CNS) radiation (standard dose) with 50.4-60 Gy delivered in 1.8 Gy-2.0 Gy fractions with concurrent temozolomide (if the patient has received a non-standard fractionation or radiation dose, such as 40 Gy in 15 fractions.
Key exclusion criteria (14 listed)
- 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
- Concomitant chemotherapy or any other systemic therapy not allowed in the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device :DaRT seedsThe 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 | Device | Experimental: DaRT seeds |
Primary outcome
Feasibility - DaRT seed placement
Time frame: From day 0 until 12 months
Feasibility will be determined according to the rate of successful placement of Alpha DaRT sources into brain tumors.
Safety - Adverse events
Time frame: From day 0 until 12 months
Safety will be determined according to incidence of acute grade 3 or greater unanticipated Adverse Events (AE) according to CTCAE v5.0 criteria
4 secondary outcomes
Toxicity profile
Time frame: within 4 weeks of completion of postoperative radiotherapy
Radiographic local tumor control
Time frame: from 1 month following surgery and onwards
Rate of pseudo-progression at first post-implant scan
Time frame: 1 month following surgery
Overall survival
Time frame: up to 12 months post implant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device :DaRT seeds in people with Recurrent Glioblastoma and Recurrent Gliomas, run by Alpha Tau Medical LTD. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - DaRT seed placement (time frame: From day 0 until 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.