Exablate BBBD for Glioblastoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Maryland, Baltimore, MDGlioblastomaExablate BBBD - Device
Eligibility
18 - 80
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new way to open the blood-brain-barrier to treat recurrent glioblastoma with carboplatin monotherapy.

Eligible Conditions
  • Glioblastoma (GBM)

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
Blood Brain Barrier Disruption (BBBD)
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Exablate BBBD

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: Through study completion, an average of 12 months

Immediately after Exablate BBBD procedure
Contrast intensity on MR imaging
Month 12
Adverse events

Trial Safety

Safety Progress

1 of 3

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1
Blood Brain Barrier Disruption (BBBD)
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Exablate BBBD

Side Effects for

Chemotherapy
58%Neutropenia
45%Nausea
36%Fatigue
34%Alopecia
30%Constipation
30%Vomiting
28%Anaemia
24%Thrombocytopenia
19%Abdominal pain
19%Diarrhoea
18%Drug hypersensitivity
16%Leukopenia
14%Asthenia
12%Pruritus
11%Headache
9%Bone pain
9%Rash
8%Dizziness
8%Oedema peripheral
8%Dyspepsia
8%Myalgia
7%Dyspnoea
7%Phlebitis
7%Insomnia
7%Dysgeusia
7%Pain in extremity
5%Peripheral sensory neuropathy
5%Decreased appetite
5%Abdominal distension
5%Arthralgia
5%Cough
5%Neuropathy peripheral
5%Paraesthesia
4%Back pain
4%Febrile neutropenia
4%Stomatitis
4%Pyrexia
4%Epistaxis
3%Musculoskeletal pain
3%Flushing
3%Abdominal pain upper
3%Lethargy
3%Nasopharyngitis
3%Urinary tract infection
3%Erythema
1%Dry skin
1%Obstruction
1%Large intesting perforation
1%Appendicitis
1%Chest pain
1%Hemorrhoids
1%Pulmonary embolism
1%Dehydration
1%Ascites
1%Sinusitis
1%Muscle spasms
1%Mucosal inflammation
This histogram enumerates side effects from a completed 2008 Phase 2 trial (NCT02004093) in the Chemotherapy ARM group. Side effects include: Neutropenia with 58%, Nausea with 45%, Fatigue with 36%, Alopecia with 34%, Constipation with 30%.

Trial Design

1 Treatment Group

Exablate BBBD with carboplatin
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Exablate BBBD · No Placebo Group · Phase 1 & 2

Exablate BBBD with carboplatinExperimental Group · 2 Interventions: Carboplatin, Exablate BBBD · Intervention Types: Drug, Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 12 months

Who is running the clinical trial?

InSightecLead Sponsor
86 Previous Clinical Trials
3,516 Total Patients Enrolled
6 Trials studying Glioblastoma
119 Patients Enrolled for Glioblastoma

Eligibility Criteria

Age 18 - 80 · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are scheduled to receive only Carboplatin as a treatment.
References

Frequently Asked Questions

Is the eligibility for this trial restricted to individuals under 30 years of age?

"This research project requires that volunteers are between 18 to 80 years old. There 97 trials available for minors, and 1068 clinical programs designed for individuals aged 65 or older." - Anonymous Online Contributor

Unverified Answer

Are there any openings for participants in this research endeavor?

"Data on clinicaltrials.gov suggests that recruitment for this medical trial is ongoing, with the initial post being made on November 6th 2020 and the last update occurring in late November 2021." - Anonymous Online Contributor

Unverified Answer

How many venues are currently conducting this experiment?

"The University of Maryland in Baltimore, Brigham and Women's Hospital in Boston, and Stanford University in Palo Alto are three locations where patients can enroll for this trial. Additionally, 4 other medical sites offer enrollment as well." - Anonymous Online Contributor

Unverified Answer

What is the upper limit of participants for this investigation?

"To launch the clinical trial, InSightec requires 30 individuals that meet its criteria. The sponsor has multiple sites for conducting this study such as University of Maryland in Baltimore and Brigham and Women's Hospital in Boston." - Anonymous Online Contributor

Unverified Answer

What other studies have utilized Exablate BBBD as part of their methodology?

"The earliest known clinical trial involving Exablate BBBD occurred in 2002, at the Health Central de Asturias. As of now, 834 trials have been completed while 702 are actively enrolling patients; particularly concentrated within Baltimore." - Anonymous Online Contributor

Unverified Answer

Am I eligible to participate in this clinical trial?

"To qualify for participation in this clinical trial, potential participants must have glioblastoma and be between 18-80 years of age. The recruitment goal is currently set at 30 individuals." - Anonymous Online Contributor

Unverified Answer

What medical condition is Exablate BBBD employed to alleviate?

"Exablate BBBD is predominantly employed to treat lymphoma and non-Hodgkin's maladies. Nonetheless, it can be put into practice for more serious conditions such as advanced sarcoma, initial treatment of cancerous growths, and Hodgkin afflictions." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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