Neoplasms Clinical Trial
Official title:
A FIH Feasibility Study to Evaluate the Safety of Transient Disruption of Blood-brain Barrier in Recurrent Glioblastoma Multiforme (GBM) Patients Using NaviFUS System
Verified date | August 2018 |
Source | NaviFUS Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 6 |
Est. completion date | June 19, 2019 |
Est. primary completion date | May 20, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - Patients diagnosed with recurrent GBM and will undergo surgery - Able to give written informed consent for the participation in the trial - Adult male/female patients > 20 years of age - Patients if already on radiotherapy, a gap of 7 days shall be maintained between the last day of radiotherapy and the day of screening - Patients if already on the steroids treatment, then should be on a stable dose of steroids for at least 7 days prior to screening - Body mass index (BMI) =17 kg / m2 - Patients with life expectancy = 3 months - Able to comply with study requirements in the opinion of the investigator - Adequate hepatic, renal, coagulation, and hematopoietic function - Hemoglobin = 10 g/dL - Platelets = 100,000/mm3 - Neutrophils = 1,500/mm3 - Normal creatinine clearance = 50mL/min - Alanine transaminase (ALT) < 3 x upper limit of normal (ULN) - Aspartate transaminase (AST) < 3 x ULN - Prothrombin time = 1.2 x ULN - International Normalized Ratio (INR) < 1.5 - Bilirubin < 2 x ULN - Patients with the ROI for FUS exposure are located close to the cortex with at least 20 mm distance beneath the skull bone and the ROI is not in the deep center brain with crucial brain functions, such as in the region of brain stem, or motor or speech regions - The Karnofsky performance status (KPS) in the patient must be > 60 Exclusion Criteria: - Patients at screening visit have arteriovenous malformation (AVM) or cerebral aneurysm - Use of any recreational drugs or history of drug addiction - Pregnant or breast-feeding women - The receipt of an investigational drug, or participation in a drug research study within a period of one month prior to the first FUS exposure - Known sensitivity/allergy to MRI contrast agents, CT contrast agents, SonoVue®, or any of its components - Any other condition that, in the investigator's judgment, might increase the risk to the patients or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study - Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints - Patients who have hemorrhage or cyst within the ROI - Severe hypertension at screening (diastolic blood pressure > 100 mmHg on medication) - Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week prior to study treatment or drugs known to increase risk or hemorrhage (e.g. Avastin) within one month prior to study treatment |
Country | Name | City | State |
---|---|---|---|
Taiwan | Linkou Chang Gung Memorial Hospital | Taoyuan City |
Lead Sponsor | Collaborator |
---|---|
NaviFUS Corporation | Chang Gung Memorial Hospital |
Taiwan,
Hynynen K, McDannold N, Sheikov NA, Jolesz FA, Vykhodtseva N. Local and reversible blood-brain barrier disruption by noninvasive focused ultrasound at frequencies suitable for trans-skull sonications. Neuroimage. 2005 Jan 1;24(1):12-20. — View Citation
Liu HL, Wai YY, Chen WS, Chen JC, Hsu PH, Wu XY, Huang WC, Yen TC, Wang JJ. Hemorrhage detection during focused-ultrasound induced blood-brain-barrier opening by using susceptibility-weighted magnetic resonance imaging. Ultrasound Med Biol. 2008 Apr;34(4):598-606. doi: 10.1016/j.ultrasmedbio.2008.01.011. Epub 2008 Mar 3. — View Citation
McDannold N, Zhang Y, Vykhodtseva N. Blood-brain barrier disruption and vascular damage induced by ultrasound bursts combined with microbubbles can be influenced by choice of anesthesia protocol. Ultrasound Med Biol. 2011 Aug;37(8):1259-70. doi: 10.1016/j.ultrasmedbio.2011.04.019. Epub 2011 Jun 8. — View Citation
Wei KC, Chu PC, Wang HY, Huang CY, Chen PY, Tsai HC, Lu YJ, Lee PY, Tseng IC, Feng LY, Hsu PW, Yen TC, Liu HL. Focused ultrasound-induced blood-brain barrier opening to enhance temozolomide delivery for glioblastoma treatment: a preclinical study. PLoS One. 2013;8(3):e58995. doi: 10.1371/journal.pone.0058995. Epub 2013 Mar 19. — View Citation
Wei KC, Tsai HC, Lu YJ, Yang HW, Hua MY, Wu MF, Chen PY, Huang CY, Yen TC, Liu HL. Neuronavigation-guided focused ultrasound-induced blood-brain barrier opening: a preliminary study in swine. AJNR Am J Neuroradiol. 2013 Jan;34(1):115-20. doi: 10.3174/ajnr.A3150. Epub 2012 Jun 21. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number and severity of AE | Safety of transient opening of the BBB by using the NaviFUS System | 45 days | |
Secondary | Tolerated dose of FUS with the NaviFUS System for transient disruption of the BBB | Dose escalation study using FUS | 7 days post-FUS | |
Secondary | Quantify the BBB disruption following BBB disruption by the NaviFUS System | Dynamic T1 contrast-enhanced MRI | 1 day |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03826043 -
THrombo-Embolic Event in Onco-hematology
|
N/A | |
Terminated |
NCT03166631 -
A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread
|
Phase 1 | |
Completed |
NCT01938846 -
BI 860585 Dose Escalation Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumors
|
Phase 1 | |
Recruiting |
NCT06058312 -
Individual Food Preferences for the Mediterranean Diet in Cancer Patients
|
N/A | |
Completed |
NCT03308942 -
Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants
|
Phase 2 | |
Recruiting |
NCT06018311 -
Exercising Together for Hispanic Prostate Cancer Survivor-Caregiver Dyads
|
N/A | |
Withdrawn |
NCT05431439 -
Omics of Cancer: OncoGenomics
|
||
Completed |
NCT01343043 -
A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1ᶜ²⁵⁹T in HLA-A2+ Patients With Synovial Sarcoma
|
Phase 1 | |
Completed |
NCT01938638 -
Open Label Phase I Dose Escalation Study With BAY1143572 in Patients With Advanced Cancer
|
Phase 1 | |
Recruiting |
NCT05514444 -
Study of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors (MK-4464-001)
|
Phase 1 | |
Recruiting |
NCT02292641 -
Beyond TME Origins
|
N/A | |
Terminated |
NCT00954512 -
Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Participants With Advanced Solid Tumors (P04722, MK-7454-004)
|
Phase 1/Phase 2 | |
Recruiting |
NCT04958239 -
A Study to Test Different Doses of BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors)
|
Phase 1 | |
Recruiting |
NCT04627376 -
Multimodal Program for Cancer Related Cachexia Prevention
|
N/A | |
Completed |
NCT01222728 -
Using Positron Emission Tomography to Predict Intracranial Tumor Growth in Neurofibromatosis Type II Patients
|
||
Recruiting |
NCT06004440 -
Real World Registry for Use of the Ion Endoluminal System
|
||
Active, not recruiting |
NCT05636696 -
COMPANION: A Couple Intervention Targeting Cancer-related Fatigue
|
N/A | |
Not yet recruiting |
NCT06035549 -
Resilience in East Asian Immigrants for Advance Care Planning Discussions
|
N/A | |
Recruiting |
NCT06004466 -
Noninvasive Internal Jugular Venous Oximetry
|
||
Completed |
NCT02909348 -
Immunophenotyping of Melanoma Patients on Treatment With Pembrolizumab
|