Clinical trials: Blood-Brain Barrier
Glioblastoma Multiforme, Brain Tumor
Safety of BBB Disruption Using NaviFUS System in Recurrent Glioblastoma Multiforme (GBM) Patients
This study is to evaluate the safety and find the tolerated ultrasound dose of transient opening of the blood-brain barrier (BBB) by using the NaviFUS System in recurrent GBM patients.
- Conditions
- Glioblastoma Multiforme, Brain Tumor, Glioblastoma, Glioma
- Trial name
- NCT03626896
- Testing
- NaviFUS System
- Where
- Taiwan
- Volunteers
- 6 people
- Sponsor
- NaviFUS Corporation
MPS IIIB (Sanfilippo B Syndrome)
Evaluation of Blood Brain Barrier Integrity and Structural Abnormalities in MPS IIIB Patients Using Multimodal Magnetic Resonance Imaging
The purpose of the study is to characterize structural abnormalities in the brain and the integrity of the blood brain barrier in patients with mucopolysaccharidosis type IIIB (MPS IIIB).
- Trial name
- NCT02090179
- Where
- United Kingdom
- Volunteers
- 5 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Glioblastoma Multiforme, Glioblastoma
Safety and Efficacy of Bevacizumab in Combination With NaviFUS System for the Treatment of Recurrent Glioblastoma Multiforme (rGBM)
This will be a prospective, open-label, single-arm pilot study to investigate the safety and efficacy of Bevacizumab (BEV) in combination with microbubble (MB)-mediated FUS in patients with recurrent GBM.
- Conditions
- Glioblastoma Multiforme, Glioblastoma, Glioma, Brain Tumor
- Trial name
- NCT06329570
- Testing
- NaviFUS System, Lumason, Bevacizumab
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- NaviFUS Corporation
Alzheimer Disease
ExAblate Blood-Brain Barrier (BBB) Disruption for the Treatment of Alzheimer's Disease
The purpose of this study is to evaluate the safety and efficacy of the ExAblate Model 4000 Type 2.0 System as a tool to disrupt the blood-brain barrier (BBB) in patients with probable Alzheimer's Disease (AD).
- Trial name
- NCT03671889
- Testing
- Blood Brain Barrier (BBB) Disruption
- Where
- 10 sites in United States
- Volunteers
- 50 people
- Sponsor
- InSightec
Healthy
A Study in Healthy Men to Investigate Uptake and Distribution of Lu AF88434 in the Brain
This study will investigate how much of Lu AF88434 will get into the blood and the brain in healthy men
- Trial name
- NCT04538014
- Testing
- Lu AF88434, [11C]-Lu AF88434
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Brain Tumor
Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric DIPG
The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier disruption with Exablate Model 4000 Type 2.0/2.1 in combination with Doxorubicin therapy for the treatment of DIPG in pediatric…
- Trial name
- NCT05615623
- Testing
- Exablate, Doxorubicin
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- InSightec
Alzheimer's Disease
A Positron Emission Tomography (PET) Study to Investigate the Brain Biodistribution of 18F GSK2647544 in Healthy Subjects to Determine Its Ability to Cross the Blood-brain-barrier.
This is an open label, PET study in healthy male subjects to determine if GSK2647544 is able to cross the blood-brain-barrier. The study will use GSK2647544 radiolabelled with fluorine-18 ([18F] GSK2647544) to determine the ratio…
- Trial name
- NCT01924858
- Testing
- GSK2647544 oral, [18F]GSK2647544 IV bolus
- Where
- United Kingdom
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Glioma, Malignant, Glioblastoma
Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption in GBM Patients
The purpose of this study is to evaluate the safety of the Exablate Model 4000 Type 2.0 used as a tool to disrupt the BBB in patients with high grade glioma undergoing standard of care therapy.
- Trial name
- NCT04998864
- Testing
- Magnetic Resonance guided Focused ultrasound (MRgFUS)
- Where
- 2 sites in Italy, Spain
- Volunteers
- 3 people
- Sponsor
- InSightec
Alzheimer Disease
ExAblate Blood-Brain Barrier Opening for Treatment of Alzheimer's Disease
The purpose of this study is to evaluate the safety and efficacy of the ExAblate® Model 4000 Type 2.0 system as a tool to open the blood-brain barrier (BBB) in patients with probable Alzheimer's Disease (AD).
- Trial name
- NCT03739905
- Testing
- Blood Brain Barrier (BBB) Disruption
- Where
- Canada
- Volunteers
- 35 people
- Sponsor
- InSightec
Glioma
ExAblate Blood Brain Barrier Disruption (BBBD) for Planned Surgery in Suspected Infiltrating Glioma
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.
- Trial name
- NCT03322813
- Testing
- ExAblate 4000 - Type 2
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- InSightec
Brain Diseases, Spinal Cord Diseases
Dose Finding Study of Gadavist in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Gadavist when used for taking images of the brain and spine.
- Trial name
- NCT00862459
- Testing
- Gadobutrol~0.03 mmol/kg BW (Gadavist, Gadovist, BAY86-4875), Gadobutrol~0.1 mmol/kg BW (Gadavist, Gadovist, BAY86-4875), Gadobutrol~0.3 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)
- Where
- 27 sites in United States, Argentina and 2 more
- Volunteers
- 237 people
- Sponsor
- Bayer
Glioblastoma Multiforme, Glioblastoma
Efficacy and Safety of NaviFUS System add-on Bevacizumab (BEV) in Recurrent GBM Patients
This is a prospective, single-arm, two stages, open-label, pilot study to investigate the efficacy and safety of FUS add-on bevacizumab (BEV) in rGBM patients.
- Conditions
- Glioblastoma Multiforme, Glioblastoma, Glioma, Brain Tumor
- Trial name
- NCT04446416
- Testing
- NaviFUS System, Bevacizumab
- Where
- Taiwan
- Volunteers
- 6 people
- Sponsor
- NaviFUS Corporation
Glioblastoma Multiforme
ExAblate Blood-Brain Barrier Disruption for Glioblastoma in Patients Undergoing Standard Chemotherapy
The purpose of this study is to evaluate the safety of the ExAblate Model 4000 Type 2.0 used as a tool to disrupt the BBB in patients with Glioblastoma undergoing standard of care therapy.
- Trial name
- NCT03712293
- Testing
- BBB Disruption with Chemotherapy Arm
- Where
- South Korea
- Volunteers
- 9 people
- Sponsor
- InSightec
Glioma
Safety and Effectiveness of Blood-Brain Barrier Disruption (BBBD) in Subjects With Suspected Infiltrating Glioma
The purpose of this study is to evaluate the safety and effectiveness of using the Exablate Type 2 system using microbubble resonators (Exablate Test Arm) to disrupt the Blood-Brain Barrier for the purpose of temporarily…
- Trial name
- BBBD (NCT04667715)
- Testing
- Exablate BBBD
- Where
- 2 sites in United States
- Sponsor
- InSightec
Brain Tumor
Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric Diffuse Intrinsic Pontine Gliomas (DIPG)
The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier disruption with Exablate Model 4000 Type2.0/2.1 in combination with Doxorubicin therapy for the treatment of DIPG in pediatric…
- Trial name
- NCT05630209
- Testing
- Exablate, Doxorubicin
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- InSightec
Alzheimer's Disease, Blood Brain Barrier
Pilot Clinical Trial to Assess the Safety of NMS-01 in Patients With Mild to Moderate Alzheimer's Disease
A single-center, single-arm, prospective, open-label, pilot clinical trial to evaluate the safety and efficacy of the Focused ultrasound stimulator system (NMS-01) for transient Blood-Brain Barrier (BBB) opening in patients with…
- Trial name
- NMSBBBOYUSH01 (NCT07869238)
- Testing
- NMS-01
- Where
- South Korea
- Volunteers
- 10 people
- Sponsor
- Neumous Inc.
Healthy Young Men
A Brain Imaging PET Study of [11C]-Lu AF90103 in Healthy Adult Male Participants
The main goals of the study are to assess uptake and distribution of Lu AF90103 in the brain when given at tracer levels (microdose) in healthy young men.
- Trial name
- NCT05306366
- Testing
- [11C]-Lu AF90103
- Where
- Sweden
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
CNS Lesion, Blood Brain Barrier Defect
P03277 Dose Finding Study in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
The purpose of this study was to determine a safe and effective dose of a new gadolinium-based contrast agent (GBCA) P03277 based on the Contrast to Noise Ratio (CNR) when comparing with gadobenate dimeglumine (MultiHance®) at…
- Trial name
- NCT02633501
- Testing
- P03277, Gadobenate dimeglumine, MRI
- Where
- 28 sites in United States, Belgium and 6 more
- Volunteers
- 312 people
- Sponsor
- Guerbet
Breast Cancer, Brain Metastases
ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases
This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells in breast cancer patients with recurrent brain metastases.
- Trial name
- NCT02048059
- Testing
- ANG1005
- Where
- 19 sites in United States
- Volunteers
- 72 people
- Sponsor
- Angiochem Inc
Parkinsons Disease With Dementia
A Study to Evaluate Temporary Blood Brain Barrier Disruption in Patients With Parkinson's Disease Dementia
The goal of this prospective, non-randomized, single-arm, feasibility study is to develop data to evaluate the safety and initial efficacy of this treatment (temporary disruption of the BBB) using this ExAblate Model 4000 Type 2…
- Trial name
- NCT03608553
- Testing
- MR Guided Focused Ultrasound
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- InSightec