Recurrent GlioblastomaODYSSEYNCT07867886
An Optimization Study Evaluating Safety and Efficacy of the Y-90 Glioblastoma (GBM) Device in Patients With Recurrent GBM
A study testing Device: TheraSphere GBM treatment of TheraSphere GBM device in people with Recurrent Glioblastoma, run by Boston Scientific Corporation at 5 sites in 4 countries.
Trial summary
The purpose of this study is to test Y90 glass microspheres for people with recurrent brain cancer. Participation in this study will help researchers find the best dose for the treatment of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Glioblastoma
- What is being tested?
- Device: TheraSphere GBM treatment of TheraSphere GBM device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 1 Oct 2026to 30 Sep 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is 18 years or older and has signed and dated the trial informed consent form (ICF)
- Life expectancy ≥ 12 weeks
- Subject is willing and able to comply with the trial testing, procedures, and follow-up schedule
- History of a histologically confirmed diagnosis of glioblastoma per 2021 WHO criteria
- Have radiographic evidence of measurable tumor progression/recurrence according to RANO 2.0 criteria
- Target lesion volume does not exceed 70 cm^3
Show all 28Show fewer
- Prior surgery and treatment with combination of radiotherapy and chemotherapy ± Tumor Treating Fields (Optune®)
- ECOG performance status ≤ 2
- The interval since completion of external beam cranial radiotherapy must be > 6 months, unless there is confirmation of tumor recurrence/progression outside the previous radiation treatment field, in which case the interval since completion of cranial radiation must be at least 12 weeks
- Interval since last systemic therapy until index procedure
- ≥ 4 weeks since last dose of temozolomide
- ≥ 4 weeks since last dose of lomustine or other nitrosourea
- ≥ 2 weeks since last dose of any oral targeted therapy (Tyrosine Kinase inhibitor or similar)
- ≥ 6 weeks from last dose of last intravenous bevacizumab infusion, or other antibody-based anti VEGF therapy
- ≥ 4 weeks since last dose of investigational agents or patient has on-going < Grade 2 AEs related to investigational agent.
- If receiving steroids, patient should be on a stable or decreasing dose equivalent to dexamethasone ≤ 6 mg/d, for at least 7 days prior to index procedure
- Have adequate organ and bone marrow function within 14 days prior to index procedure, as defined below:
- INR ≤ 1.5 (in absence of anticoagulation)
- Platelets ≥ 75,000/L
- Creatinine ≤1.5 mg/dL
- Absolute Neutrophil Count ≥1.5 x 109/L
- Hemoglobin ≥9.0 g/dL
- For female of child-bearing potential:
- Have a negative pregnancy test within 14 days prior to index procedure
- If sexually active must be using, or agree to use, an acceptable method of birth control as confirmed by the investigator for the duration of their participation in the study
- If currently breastfeeding, must agree to stop breastfeeding
- Angiographic Criteria:
- The intent of therapy should be to encompass the entire radiographically defined target lesion within the PV b. Each PV is ≤ 150cc, with the total PV not exceeding 400cc
Who cannot join
- None of the following exclusion criteria can be met:
- Have leptomeningeal disease or other primary malignancy metastatic to the brain
- Target lesion located in or involving the infratentorial space, thalamus, hypothalamus, internal capsule, or optic chiasma
- Have received more than 1 course of prior cerebral radiotherapy (EBRT)
- Prior cranial radiation dose ≥ 66 Gy
- Have received radiosurgery, brachytherapy, or hypofractionated radiotherapy
Show all 23Show fewer
- Have received more than 2 systemic anti-tumor treatment protocols (lines of treatment), not including neoadjuvant or adjuvant temozolomide (oral or IV)
- Have received more than 2 surgical GBM-related procedures
- Patients with a history of stroke, ischemic cerebral disease, and/or at risk of cerebral herniation
- Are at increased risk of wound dehiscence by the discretion of the investigators (e.g. recent brain surgery, poor skin condition, and/or previously infected surgical field or any other condition that is of increased infectious risk in the opinion of the treatment team)
- Have uncontrolled epilepsy
- Have severe and/or insufficiently controlled intercurrent illness; patients with the following are not eligible:
- Hypertension grade 3 or higher without adequate control on medications
- Symptomatic or unstable cardiac disease,
- Ongoing or active bacterial or viral infection requiring systemic treatment (including HIV)
- Psychiatric illness/social situations that would limit compliance with study requirements
- Peripheral Neuropathy ≥ grade 1
- Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints
- Patients with a history of an active other malignancy within 1 year prior to index procedure. NOTE: Exceptions to this requirement include adequately treated non-melanoma skin cancer or carcinoma in situ without evidence of disease
- Medical contraindication to undergo contrast-enhanced magnetic resonance imaging (MRI)
- Known history of severe uncorrectable reactions to iodinated and/or gadolinium-based contrast
- Subject is currently participating, or plans to participate in, another investigational trial that may confound the results of this trial (unless written approval is received from the Boston Scientific study team).
- Angiographic Criteria: Patients with evident AV shunting, vascular disease or tortuosity precluding safe or feasible vascular access, or patient vasculature not conducive to delivery of the therapy on baseline imaging or angiography.
Trial locations and contacts
5 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 4 countries
France2 sites
Hospices Civils de Lyon - Hopital Louis Pradel
Bron, 69500
Pauline Bonazza, pauline.bonazza@chu-lyon.fr
pauline.bonazza@chu-lyon.fr
Hôpital de La Timone
Marseille, 13005
Maryannick F Le Ray, maryannick.le-ray@ap-hm.fr
Jean F Hak, MD
Germany1 site
Universitätsklinikum Tübingen
Tübingen, 72074
Maren Pritzkow, maren.pritzkow@med.uni-tuebingen.de
Christian la Fougere, MD
Netherlands1 site
University Medical Center Utrecht
Utrecht, 3584
Dominique Grobbe, studiecoordinatie-NUG@umcutrecht.nl
Ellen Dekkers, studiecoordinatie-NUG@umcutrecht.nl
Spain1 site
Vall d'Hebron Institute of Oncology
Barcelona, 08035
Sara Hebera Llufriu, saraherbera@vhio.net
Diego Gomez Puerto, MD
About this study
Official title: The ODYSSEY Study: An Optimization Study Evaluating Safety and Efficacy of the Y-90 Glioblastoma (GBM) Device in Patients With Recurrent GBM
The purpose of this study is to test Y90 glass microspheres for people with recurrent brain cancer. Participation in this study will help researchers find the best dose for the treatment of the disease. The study will look at the safety of the Y90 glass microsphere device and if it works to help stop the growth of the tumor.
In this study, the device is delivered directly to the tumor through the blood vessels/arteries using a catheter(s) (a specialized tubing). The device (very small glass beads) gives radiation directly to the tumor and nearby area.
Although radiation is a standard treatment for most types of brain cancer, the delivery of radiation using the Y90 glass microsphere device differs and is an investigational procedure. To deliver the device a catheter(s) will be inserted through a blood vessel/artery in the forearm or groin, followed by an in-hospital stay after the treatment of up-to 36 hours. Participants will have regular follow-up visits with the study doctor to monitor their health and assess how the tumor responds to treatment. These visits will take place weekly during the first month, monthly for the next five months, and then approximately every two months until one year after treatment.
- Conditions
- Recurrent Glioblastoma
- Being tested
- Device: TheraSphere GBM treatment of TheraSphere GBM device
- Keywords
- Glioblastoma, Glioblastoma Multiforme (GBM), Recurrent Glioblastoma, Recurrent GBM, Brain Neoplasms, Malignant Glioma, Yttrium-90, Y-90, Radioembolization, Brachytherapy, Intratumoral Radiation, Localized Radiation Therapy, Neuro-Oncology, Recurrent Brain Tumor, Neurovascular Radiotherapy (NVRT)
- Medical subject headings
- Glioblastoma, Brain Neoplasms, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: TheraSphere GBM treatment of TheraSphere GBM deviceDevice
All patients participating in the study will receive the same device. The study is evaluating the safety and efficacy of the device when it is used to deliver radiation to the area of the brain containing the tumor. The amount of radiation a patient receives depends on the dose group (cohort) to which they are assigned. Patients will be treated in groups of three at each dose level. If a dose level is considered safe, the next group of patients will receive a higher dose
| Study group | Role | What they receive |
|---|---|---|
| Y90 GBM Device Treatment | Experimental | Subjects are eligible if each treatment area supplied by a targeted blood vessel (perfused volume, PV) is 150 cc or less, and the total perfused volume does not exceed 400 cc.
This is a dose-escalation study designed to determine the safest and most appropriate radiation dose. The planned radiation dose to the treatment area ranges from 60 Gy to 120 Gy. The study will begin at a dose of 60 Gy, with dose increases of 20 Gy for subsequent patient groups.
Patients will be treated in groups of three at each dose level. If a particular dose level is found to be safe, the next group of patients may receive the next higher dose level, stay at the same dose level, or de-escalate the dose level depending on the rate of Dose Limiting Toxicities and Data Monitoring Committee determination. Receives: Device: Device: TheraSphere GBM treatment of TheraSphere GBM device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated radiation absorbed dose (MTRAD) of the Y90 microspheres device to the perfused volume (PV) corresponding to a DLT of smaller equals 33%
The MTRAD of Y-90 microspheres to the PV corresponding to a Dose Limiting Toxicity (DLT) rate of ≤33% through 30 days observation period from the index procedure. A DLT is defined as any device-related ≥Grade 3 adverse event, excluding radiographic-only cerebral edema and symptomatic cerebral edema if symptoms improve within 7 days of initiation of medical management.
Measured: Through the 30-day observation period from the index procedure.
Secondary outcomes (21)
Rate of Adverse Events (AEs) throughout follow up period (any causality, severity, and duration):
Measured: From mapping procedure through study follow-up, assessed for up to 36 months
Rate of radiation-related neurotoxicity throughout follow up period (any causality, severity, and duration)
Measured: From mapping procedure through study follow-up, assessed for up to 36 months
Rate of Serious AEs throughout follow up period (any causality, severity, and duration)
Measured: From mapping procedure through study follow-up, assessed for up to 36 months
Rate of procedure-related AEs throughout follow up period (any causality, severity, and duration)
Measured: From mapping procedure through study follow-up, assessed for up to 36 months
Rate of device-related AEs throughout follow up period (any causality, severity, and duration)
Measured: From mapping procedure through study follow-up, assessed for up to 36 months
Disease Control Rate, overall (DCR)
Measured: From enrollment through 12 month following treatment
Disease Control Rate within the PV (DCR)
Measured: From enrollment through 12 month following treatment
Progression Free Survival, overall (PFS)
Measured: From enrollment for up to 36 months
Progression Free Survival within the PV (PFS)
Measured: From enrollment until disease progression or death, assessed for up to approximately 36 months
Overall Survival (OS)
Measured: From enrollment for up to 36 months.
Time to subsequent anticancer treatment
Measured: From date of index procedure through the 12 month visit
Change from baseline in Quality of Life (QoL) scores per EORTC QLQ-C30
Measured: From Screening to 6 month visit
Change from baseline in Quality of Life (QoL) score per EORTC QLQ-BN20
Measured: From Screening to 6 month visit
Change from baseline in neurocognitive function as measured by Hopkins Verbal Learning Test (HVLT-R).
Measured: From Screening to 6 month visit
Change from baseline in neurocognitive function as measure by Trail Making Test A (TMTA)
Measured: From Screening to 6 month visit
Change from baseline in neurocognitive function as measure by Trail Making Test B (TMTB)
Measured: From Screening to 6 month visit
Change from baseline in neurocognitive function as measured by Controlled Oral Word Association (COWA)
Measured: From Screening to the 6 month visit
Change from baseline in post-treatment neurological function as assessed by the National Institute of Health Stroke Scale (NIHSS)
Measured: From Screening to 12 month visit
Change form baseline in post-treatment neurological function as assessed by Modified Rankin Score (MRS)
Measured: From Screening to 12 month visit
Relationship between absorbed dose to PV and safety
Measured: From enrollment through the 12 month period following treatment
Relationship between absorbed dose to PV and efficacy endpoints
Measured: From enrollment through 12 month period following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion28 Oct 2028 (estimated)
- Study completion30 Sep 2029 (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 Boston Scientific CorporationThe 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA RDS Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867886
- Sponsor's protocol ID
- S2526
- Other IDs
- CIV-2025-11-055434
- Acronym
- ODYSSEY
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ODYSSEY Study: An Optimization Study Evaluating Safety and Efficacy of the Y-90 Glioblastoma (GBM) Device in Patients With Recurrent GBM
- ClinicalTrials.gov ID
- NCT07867886
- Acronym / sponsor ID
- ODYSSEY / S2526
- Conditions
- Recurrent Glioblastoma
- Keywords
- Glioblastoma, Glioblastoma Multiforme (GBM), Recurrent Glioblastoma, Recurrent GBM, Brain Neoplasms, Malignant Glioma, Yttrium-90, Y-90
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA RDS Inc.
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 28 Oct 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 9 Oct 2026 (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.
The purpose of this study is to test Y90 glass microspheres for people with recurrent brain cancer. Participation in this study will help researchers find the best dose for the treatment of the disease. The study will look at the safety of the Y90 glass microsphere device and if it works to help stop the growth of the tumor.
In this study, the device is delivered directly to the tumor through the blood vessels/arteries using a catheter(s) (a specialized tubing). The device (very small glass beads) gives radiation directly to the tumor and nearby area.
Although radiation is a standard treatment for most types of brain cancer, the delivery of radiation using the Y90 glass microsphere device differs and is an investigational procedure. To deliver the device a catheter(s) will be inserted through a blood vessel/artery in the forearm or groin, followed by an in-hospital stay after the treatment of up-to 36 hours. Participants will have regular follow-up visits with the study doctor to monitor their health and assess how the tumor responds to treatment. These visits will take place weekly during the first month, monthly for the next five months, and then approximately every two months until one year after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Y90 GBM Device Treatment | Experimental | Device: Device: TheraSphere GBM treatment of TheraSphere GBM deviceSubjects are eligible if each treatment area supplied by a targeted blood vessel (perfused volume, PV) is 150 cc or less, and the total perfused volume does not exceed 400 cc. This is a dose-escalation study designed to determine the safest and most appropriate radiation dose. The planned radiation dose to the treatment area ranges from 60 Gy to 120 Gy. The study will begin at a dose of 60 Gy, with dose increases of 20 Gy for subsequent patient groups. Patients will be treated in groups of three at each dose level. If a particular dose level is found to be safe, the next group of patients may receive the next higher dose level, stay at the same dose level, or de-escalate the dose level depending on the rate of Dose Limiting Toxicities and Data Monitoring Committee determination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Subject is 18 years or older and has signed and dated the trial informed consent form (ICF)
- Life expectancy ≥ 12 weeks
- Subject is willing and able to comply with the trial testing, procedures, and follow-up schedule
- History of a histologically confirmed diagnosis of glioblastoma per 2021 WHO criteria
- Have radiographic evidence of measurable tumor progression/recurrence according to RANO 2.0 criteria
Key exclusion criteria (23 listed)
- Have leptomeningeal disease or other primary malignancy metastatic to the brain
- Target lesion located in or involving the infratentorial space, thalamus, hypothalamus, internal capsule, or optic chiasma
- Have received more than 1 course of prior cerebral radiotherapy (EBRT)
- Prior cranial radiation dose ≥ 66 Gy
- Have received radiosurgery, brachytherapy, or hypofractionated radiotherapy
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: TheraSphere GBM treatment of TheraSphere GBM deviceAll patients participating in the study will receive the same device. The study is evaluating the safety and efficacy of the device when it is used to deliver radiation to the area of the brain containing the tumor. The amount of radiation a patient receives depends on the dose group (cohort) to which they are assigned. Patients will be treated in groups of three at each dose level. If a dose level is considered safe, the next group of patients will receive a higher dose | Device | Y90 GBM Device Treatment |
Primary outcome
Maximum tolerated radiation absorbed dose (MTRAD) of the Y90 microspheres device to the perfused volume (PV) corresponding to a DLT of smaller equals 33%
Time frame: Through the 30-day observation period from the index procedure.
The MTRAD of Y-90 microspheres to the PV corresponding to a Dose Limiting Toxicity (DLT) rate of ≤33% through 30 days observation period from the index procedure. A DLT is defined as any device-related ≥Grade 3 adverse event, excluding radiographic-only cerebral edema and symptomatic cerebral edema if symptoms improve within 7 days of initiation of medical management.
21 secondary outcomes
Rate of Adverse Events (AEs) throughout follow up period (any causality, severity, and duration):
Time frame: From mapping procedure through study follow-up, assessed for up to 36 months
Rate of radiation-related neurotoxicity throughout follow up period (any causality, severity, and duration)
Time frame: From mapping procedure through study follow-up, assessed for up to 36 months
Rate of Serious AEs throughout follow up period (any causality, severity, and duration)
Time frame: From mapping procedure through study follow-up, assessed for up to 36 months
Rate of procedure-related AEs throughout follow up period (any causality, severity, and duration)
Time frame: From mapping procedure through study follow-up, assessed for up to 36 months
Rate of device-related AEs throughout follow up period (any causality, severity, and duration)
Time frame: From mapping procedure through study follow-up, assessed for up to 36 months
Disease Control Rate, overall (DCR)
Time frame: From enrollment through 12 month following treatment
Disease Control Rate within the PV (DCR)
Time frame: From enrollment through 12 month following treatment
Progression Free Survival, overall (PFS)
Time frame: From enrollment for up to 36 months
Progression Free Survival within the PV (PFS)
Time frame: From enrollment until disease progression or death, assessed for up to approximately 36 months
Overall Survival (OS)
Time frame: From enrollment for up to 36 months.
Time to subsequent anticancer treatment
Time frame: From date of index procedure through the 12 month visit
Change from baseline in Quality of Life (QoL) scores per EORTC QLQ-C30
Time frame: From Screening to 6 month visit
Change from baseline in Quality of Life (QoL) score per EORTC QLQ-BN20
Time frame: From Screening to 6 month visit
Change from baseline in neurocognitive function as measured by Hopkins Verbal Learning Test (HVLT-R).
Time frame: From Screening to 6 month visit
Change from baseline in neurocognitive function as measure by Trail Making Test A (TMTA)
Time frame: From Screening to 6 month visit
Change from baseline in neurocognitive function as measure by Trail Making Test B (TMTB)
Time frame: From Screening to 6 month visit
Change from baseline in neurocognitive function as measured by Controlled Oral Word Association (COWA)
Time frame: From Screening to the 6 month visit
Change from baseline in post-treatment neurological function as assessed by the National Institute of Health Stroke Scale (NIHSS)
Time frame: From Screening to 12 month visit
Change form baseline in post-treatment neurological function as assessed by Modified Rankin Score (MRS)
Time frame: From Screening to 12 month visit
Relationship between absorbed dose to PV and safety
Time frame: From enrollment through the 12 month period following treatment
Relationship between absorbed dose to PV and efficacy endpoints
Time frame: From enrollment through 12 month period following treatment
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 9 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Recurrent Glioblastoma
Active, not recruitingPhase 1/2
Ultrasound-based Blood-brain Barrier Opening and Albumin-bound Paclitaxel and Carboplatin for Recurrent Glioblastoma
Glioblastoma, Gliosarcoma
Active, not recruitingPhase 1
Safety and Efficacy Study of Anti-B7-H3 CAR-T Cell Therapy for Recurrent Glioblastoma
Glioblastoma
Active, not recruitingPhase 2
A Study Testing the Effect of Immunotherapy (Ipilimumab and Nivolumab) in Patients With Recurrent Glioma With Elevated Mutational Burden
Astrocytoma, IDH-Mutant, Grade 4, Diffuse Glioma
Active, not recruitingPhase 1
A Trial of Belzutifan (PT2977, MK-6482) Tablets In Patients With Advanced Solid Tumors (MK-6482-001)
Advanced Solid Tumors, Solid Tumor
RecruitingPhase 1
Locoregional Administration of Genetically Engineered Cells (EGFR/IL13Rα2 Pool-CAR T Cells) for the Treatment of Recurrent or Progressive High-Grade Gliomas
Recurrent Astrocytoma, IDH-Mutant, Grade 4, Recurrent Glioblastoma, IDH-Wildtype
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.
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device: TheraSphere GBM treatment of TheraSphere GBM device in people with Recurrent Glioblastoma, run by Boston Scientific Corporation at 5 sites in 4 countries.
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 28 inclusion and 23 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: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Germany, Netherlands, Spain. 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?
Maximum tolerated radiation absorbed dose (MTRAD) of the Y90 microspheres device to the perfused volume (PV) corresponding to a DLT of smaller equals 33% (time frame: Through the 30-day observation period from the index procedure.). 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 9 Oct 2026.