Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06098872
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2023-10-17
Brief Title:
Pilot Study on Trametinib for Surgical Unruptured AVMs
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Pilot Study on the Efficacy of MEK1MEK2 Inhibitor Trametinib in Patients With Surgical Unruptured Arteriovenous Malformations
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Arteriovenous malformation AVM is a tangle of abnormal vessels that can progress through life and cause significant bleeding deformity pain and deficits in day-to-day activities Surgery is a common treatment option for patients with AVMs where the goal is to safely remove the entire AVM without causing complications While any surgery has its potential risks most of the potential modifiable risk factors relate to the AVMs structure such as the AVM size or presence of high risk structural features seen on scans The purpose of this pilot study is to see whether taking an oral medication called Trametinib can improve upon the AVM structure in adult patients before their scheduled surgery
Detailed Description:
The goal of this pilot clinical trial is to see whether an oral medication called Trametinib can be given to patients with arteriovenous malformations AVMs of the brain and body before surgery in order to make the AVM structure less risky for surgery
The main questions it aims to answer are
1 does taking Trametinib make the structure of the AVM less risky for surgery This will determined by comparing the size and structure of the AVM on repeat scans before and after taking the drug
2 does taking Trametinib reduce the blood flow to the AVM This will be determined by quantifying the blood flow to the AVM with quantitative magnetic resonance imaging software
3 is the drug well tolerated in this patient population This will be determined by following for any side effects of the medication
4 how does the drug do what it is supposed to do clinically by looking at its effect at the cell level This will be determined by taking a piece of the AVM that is removed at the time of surgery and running experiments in the lab to compare its structure and behaviour to other AVMs that were not treated with this medication
Participants will first undergo screening tests to ensure they are candidates for the medication They will take oral Trametinib once daily for a total of 60 days prior to their planned surgery They will be monitored for side effects at days 15 30 and 60 They will undergo routine scans prior to starting the drug and then again within 5 days of their last dose to see any changes made to the AVM structure after taking the drug Lastly at the time of surgery a part of the AVM removed will be sent to our research lab to see what the drug is doing at the cell level to result in the changes we can see on the scans
The main questions it aims to answer are
1 does taking Trametinib make the structure of the AVM less risky for surgery This will determined by comparing the size and structure of the AVM on repeat scans before and after taking the drug
2 does taking Trametinib reduce the blood flow to the AVM This will be determined by quantifying the blood flow to the AVM with quantitative magnetic resonance imaging software
3 is the drug well tolerated in this patient population This will be determined by following for any side effects of the medication
4 how does the drug do what it is supposed to do clinically by looking at its effect at the cell level This will be determined by taking a piece of the AVM that is removed at the time of surgery and running experiments in the lab to compare its structure and behaviour to other AVMs that were not treated with this medication
Participants will first undergo screening tests to ensure they are candidates for the medication They will take oral Trametinib once daily for a total of 60 days prior to their planned surgery They will be monitored for side effects at days 15 30 and 60 They will undergo routine scans prior to starting the drug and then again within 5 days of their last dose to see any changes made to the AVM structure after taking the drug Lastly at the time of surgery a part of the AVM removed will be sent to our research lab to see what the drug is doing at the cell level to result in the changes we can see on the scans
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OZUHN-017 | OTHER | Ozmosis | None |