An interventional study of ExAblate 4000 - Type 2 in Glioma, sponsored by InSightec. Suspended at 1 site in United States. Open to participants aged 21 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-08-03.
Sponsored by InSightec · Not applicable, Interventional, and Treatment
Among 851 studies in Glioma with a site in United States — 143 open to participants now, 229 under way, 6 of them phase 3. Glioma · United States.
Among the 851 studies in Glioma with a site in United States, this one is the 519th largest by planned enrollment of the 737 interventional ones that give a count, is one of 35 that started in 2023, is one of 86 with no phase, and was the 534th registered.
1,452 studies on the registry are indexed under Glioma; 349 are open to participants now.
Browse Glioma studies →143 of the 851 studies in Glioma with a site in United States are open now. Recruiting first, the newest first:
Nuvation Bio Inc. · Sites in United States
Ages 18+
Children's Hospital of Philadelphia · Sites in United States
Ages 1–21
Beijing Inno Medicine Co., Ltd. · Sites in United States, China
Ages 18–70
Neonc Technologies, Inc. · Sites in United States
Ages 5–18
Children's National Research Institute · Sites in United States
Ages 3–25
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 267 Glioma studies recruiting now, 164 (61%) set no upper age limit and 57 (21%) stop at 75 or younger; 63 take children under 18; 15 take healthy volunteers.
This study: 21 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
851 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 430 · Phase 2 320 · Phase 3 21 · Phase 4 6
First in 1979; this study’s year is marked. 35 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 15 is below the median of 32 across 1,075 interventional studies indexed under Glioma.
Median enrollment 30 across the 737 interventional studies, 69 across the 77 observational. Of the 564 that completed or were terminated, 203 (36%) have results posted.
This tab as a report to print or save as PDF → With an account.
172 of 851 have an industry lead sponsor. The 10 most frequent:
InSightec is the lead sponsor of 84 studies on the registry; 9 are open to participants now.
InSightec has 6 studies filed under Glioma — fewer than ten, so there is no comparison to draw.
88 of the studies in Glioma with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT00978458Phase 3Eastern Cooperative Oncology GroupRadiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma | 2026-12-31 |
| NCT05271240Phase 3Northwell HealthRepeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed GBM | 2027-04-01 |
| NCT07814872Harvard Medical School (HMS and HSDM)A Preregistered Multi-Cohort Evaluation of the FATHOM AI System for Molecular Testing Prioritization to Support Clinical Trial Enrollment | 2026-11 |
| NCT03510208Stanford UniversityPanitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery | 2026-11 |
| NCT05094336AmgenA Study of Anvumetostat in Participants With Advanced MTAP-null Solid Tumors (MTAPESTRY 101) | 2026-11-30 |
Add all 88 to your calendar (.ics) → With an account.
Among the 851 studies in Glioma with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study is designed to assess the safety and feasibility of using the ExAblate, Type 2 to temporarily disrupt the blood brain barrier in non-enhancing suspected infiltrating glioma. The ExAblate Model 4000 Type-2 is intended for use as a tool to disrupt the BBB.
This study is a prospective, single-arm, non-randomized, open-label feasibility study to evaluate the safety of focal BBBD using the ExAblate® 4000 Type 2 system. Up to 15 subjects with suspected infiltrating glioma who are scheduled to undergo brain tumor resection may be recruited for the study. Only patients that have a non-enhancing tumor components in a non-eloquent region of the planned standard-of-care resection volume will be eligible. Up to 4 centers may participate in this study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
MRI or clinical findings of:
Any to MRI scanning, including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ExAblate BBBD
Device: ExAblate 4000 - Type 2
Using ExAblate Model 4000 Type-2 to temporarily disrupt the blood brain barrier in non-enhancing suspected infiltrating glioma undergoing resection
Also known as: ExAblate BBBD
Device and procedure related adverse events
The number and severity of device and BBBD procedure related adverse events will be evaluated.
Time frame: At the time of the ExAblate MRgFUS procedure
Feasibility of BBB disruption
The extent and reversibility of BBB opening will be determined by the degree of contrast enhancement seen on post-procedure MRI with contrast agent
Time frame: At the time of the ExAblate MRgFUS procedure and 24 hours post-procedure
Start is estimated for Oct 2023; primary completion for Sep 2024, 11 months later.
How these figures are worked out, and which studies are left out of them.
This study is suspended, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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