Clinical trials: Blood-Brain Barrier
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
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.
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
Recurrent Glioblastoma
Exablate Blood-Brain Barrier Disruption With Carboplatin for the Treatment of rGBM
The purpose of this study is to evaluate the safety and feasibility of the Exablate Model 4000 Type 2 system when used as a tool to open the blood-brain-barrier (BBB) in subjects with recurrent glioblastoma (rGBM) undergoing…
- Trial name
- NCT04440358
- Testing
- Exablate BBBD, Carboplatin
- Where
- 3 sites in Canada, Italy and 1 more
- Volunteers
- 13 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
CNS Lesion, Blood Brain Barrier Defect
Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
This trial aimed to evaluate the Efficacy and Safety of gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
- Trial name
- PICTURE (NCT03996447)
- Testing
- gadopiclenol, Gadobutrol 1Mmol/mL Solution for Injection Vial
- Where
- 33 sites in United States, Belgium and 9 more
- Volunteers
- 260 people
- Sponsor
- Guerbet
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
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
Breast Cancer, Brain Metastases
GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases
The purpose of this study is to assess the efficacy, safety, and tolerability of GRN1005 in patients with brain metastases from breast cancer.
- Trial name
- GRABM-B (NCT01480583)
- Testing
- GRN1005, Trastuzumab, 18F-FLT
- Where
- 2 sites in United States
- Volunteers
- 85 people
- Sponsor
- Angiochem Inc
HER2-positive Breast Cancer
RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive
The purpose of this study is to assess the efficacy and safety of RO7771950 in combination with trastuzumab and capecitabine, compared to tucatinib in combination with trastuzumab and capecitabine.
- Trial name
- BREnnA (NCT07413939)
- Testing
- RO7771950, Tucatinib, Trastuzumab
- Where
- 219 sites in United States, Argentina and 24 more
- Volunteers
- 650 people
- Sponsor
- Hoffmann-La Roche
Brain Tumor, Non Small Cell Lung Cancer
Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets
The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier opening with Exablate Model 4000 Type 2.0/2.1 for the treatment of NSCLC brain metastases in patients who are undergoing planned FDA…
- Trial name
- LIMITLESS (NCT05317858)
- Testing
- Blood Brain Barrier Opening - Oncology, Pembrolizumab, Atezolizumab
- Where
- 16 sites in United States, Canada and 1 more
- Volunteers
- 96 people
- Sponsor
- InSightec
Parkinson Disease
Blood-Brain-Barrier Disruption With Cerezyme in Patient's With Parkinson's Disease
This clinical trial focus on the delivery of Cerezyme® in Parkinson's Disease (PD) patients using MR-guided focused ultrasound (MRgFUS) induced opening of the blood-brain barrier (BBB).
- Trial name
- NCT04370665
- Testing
- Exablate BBBD with Cerezyme
- Where
- Canada
- Volunteers
- 4 people
- Sponsor
- InSightec
Healthy Participants
A Brain Imaging PET Study of [11C]-Lu AF88370 in Healthy Adult Male Participants
The main goals of the study are to assess uptake and distribution of Lu AF88370 in the brain when given at tracer levels (microdose) in healthy young men.
- Trial name
- NCT05320302
- Testing
- [11C]-Lu AF88370
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Non-small Cell Lung Cancer (NSCLC) With Brain Metastases
GRN1005 in Non-Small Cell Lung Cancer (NSCLC) Patients With Brain Metastases (GRABM-L)
The purpose of this study is to assess the efficacy, safety, and tolerability of GRN1005 in patients with brain metastases from non-small cell lung cancer (NSCLC).
- Trial name
- GRABM-L (NCT01497665)
- Testing
- GRN1005
- Where
- 10 sites in United States, Canada
- Volunteers
- 16 people
- Sponsor
- Angiochem Inc
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
Brain Tumor
Blood-Brain Barrier Disruption Using Transcranial MRI-Guided Focused Ultrasound
The purpose of this study is to evaluate the safety of BBB disruption using transcranial MRI-guided focused ultrasound in conjunction with an intravenous ultrasound contrast agent to increase the accumulation of doxorubicin in…
- Trial name
- NCT02343991
- Testing
- Transcranial ExABlate
- Where
- Canada
- Volunteers
- 5 people
- Sponsor
- InSightec
CNS Disease
Blood-Brain Barrier Penetration of Therapeutic Agents in Human
This is a phase 1, open-label, non-randomized, exploratory, repeated dose PK study performed at a single centre. Up to 6 evaluable subjects are planned. The subjects will receive p.o. doses of ODM-104 for 5-7 days.
- Trial name
- BRIAN (NCT04571996)
- Testing
- ODM-104, Paracetamol
- Where
- Finland
- Volunteers
- 4 people
- Sponsor
- Orion Corporation, Orion Pharma
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
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
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