None listed
Conditions
Brief summary
The EMBO-01 study is a first-in-human study of a new investigational device, the Distal Penetrating Embolic System (DPE), for pre-operative embolisation of a type of brain tumour that is hypervascular (has a lot of blood vessels) and extra-axial (not part of normal brain tissue). The purpose of this study is to assess the safety and feasibility of using DPE in patients with these types of brain tumours, and to assess whether embolisation can reduce blood loss during surgery and make the tumour easier to remove. Who is it for? You may be eligible for this study if you are aged between 18 and 80 years (inclusive), have been diagnosed with a hypervascular extra-axial brain tumour, and are planned for pre-operative embolisation and subsequent surgical removal of the tumour within the next 7 days. Study details All participants will undergo the embolisation procedure within 7 days of their surgery. Embolisation is a separate procedure in which a material known as an “embolic agent” is injected into the blood vessel(s) to form a plug within the vessels to stop blood flow to the tumour. The procedure will be done by a specialised doctor called a neurointerventional radiologist, and will take approximately 2 hours to complete. An x-ray will be performed before and after the embolisation process to document successful injection of the DPE into the target vessels supplying the tumour and the effects of this on blood supply to the tumour. During the surgical procedure to remove the tumour, data will also be collected such as blood loss, surgical time, and time taken to remove the tumour. The removed tumour may then be analysed by a pathologist. Additionally, participants will be asked to complete a number questionnaires for up to 90 days post-embolisation to assess for any complications of the procedure. It is hoped that this study may show that pre-operative embolisation using the DPE is safe and feasible in patients with hypervascular extra-axial brain tumours. It is also hoped that the procedure is able to reduce blood loss during surgery and reduce the time taken to remove the tumour, which may lead the way for a larger trial.
Interventions
Participants will have their hypervascular, extra-axial brain tumour embolised with a novel embolic agent, the DPE, in a single procedure performed by a board-certified neurointerventional radiologist prior to having the tumour surgically removed. The embolisation procedure will be done in an operating room and is expected to take about 2 hours. Before the procedure starts, baseline computed tomography (CT) imaging is done to take pictures of the blood vessels in the brain that supply the brai
Participants will have their hypervascular, extra-axial brain tumour embolised with a novel embolic agent, the DPE, in a single procedure performed by a board-certified neurointerventional radiologist prior to having the tumour surgically removed. The embolisation procedure will be done in an operating room and is expected to take about 2 hours. Before the procedure starts, baseline computed tomography (CT) imaging is done to take pictures of the blood vessels in the brain that supply the brain tumour. The participant is anesthetised for the embolisation procedure. A catheter (a thin, flexible tube) is inserted into a small incision in the inner thigh or wrist and advanced through the blood vessels into the brain. During this time contrast dye will be injected into the catheter and x-ray images (digital subtractive angiography) are taken. Once the catheter is placed at the vessel which needs to be embolised, the DPE is injected until the material fills the blood vessel and stops the blood flow. The study doctor may treat more than one target vessel in order to stop or reduce blood flow to the tumour. X-ray images (digital subtractive angiography) will be taken of the embolised blood vessels. At the end of the procedure CT imaging is repeated to record the placement of the embolic material. A clinical specialist from the Sponsor who is a technical expert on the DPE will attend the embolisation procedure and make sure the protocol is being followed and all the information about the procedure is recorded according to the protocol. The CT and X-ray images from the procedure will be reviewed by an Imaging Core Lab to make sure the embolisation procedure was successful in placing the DPE where it was needed to stop the blood flow, and that no DPE was placed where it was not needed. The tumour will then be removed in a surgical procedure no sooner than 12 hours after the end of the embolisation procedure and no later than 7 days after the end of the embolisation procedure. The investigational procedure is the pre-operative embolisation; surgical removal of the tumor is done by a neurosurgeon according to hospital standard of care.
Sponsors
Arsenal Medical Australia Pty Ltd,
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Screening Inclusion Criteria: • Participant whose age is between 18 and 80 years; • Participant whose baseline mRS score is less than or equal to 2; • Contrast enhancing extra-axial supratentorial brain tumour measuring between 2.5 cm and 6 cm in the greatest diameter; • Participant planned for pre-operative embolisation followed by neurological assessment, and subsequent surgical resection under a separate general anesthesia protocol within the next 7 days; • Participant understands the nature of the procedure, consents to participation in the study and provides a signed informed consent form; • Participant (woman of child-bearing potential) with a current negative pregnancy test who has agreed to an effective method of contraception throughout the study; • Participant is willing to return to or call the investigational site for 30-day and 90-day follow-ups. Baseline Inclusion Criteria: • Digital subtractive angiography (DSA) demonstrates a hypervascular tumour blush supplied by branches of the middle meningeal artery which both originates from the external carotid artery and is amenable to catheterisation with a standard microcatheter • A negative pregnancy test is required at baseline for a woman of child-bearing potential
Exclusion criteria
Screening Exclusion Criteria: • Tumours originating from the skull base except lateral sphenoid wing • Participant who is breastfeeding • Participant with life expectancy of less than 1 year • Prior embolisation, radiation therapy, or surgical treatment of the tumour • Participants with renal impairment that the investigator assesses could be at risk for contrast induced nephropathy • Participant with a life-threatening allergy to radiographic contrast (unless treatment for allergy is tolerated or can be managed medically) • Participant is allergic to any of the materials used in the DPE device Participant who is currently participating or planning to participate within 3 months in another non-observational clinical research study Baseline Exclusion Criteria: • Digital subtractive angiography (DSA) demonstrates vasculature not amenable to catheterisation or embolisation including high-risk anastomoses with eloquent arteries
Outcome results
None listed