Surgical Tissue Flap to Bypass the Blood Brain Barrier in Glioblastoma (NCT05954858) | Clinical Trial Compass
RecruitingNot Applicable
Surgical Tissue Flap to Bypass the Blood Brain Barrier in Glioblastoma
United States32 participantsStarted 2023-06-29
Plain-language summary
This single center, single arm, open-label, phase 2 study will assess the safety and efficacy of a pedicled temporoparietal fascial (TPF) or pericranial flap into the resection cavity of newly diagnosed glioblastoma multifome (GBM) patients.
The objective of the Phase 2 study is to demonstrate that this surgical technique is safe and effective in a human cohort of patients with resected newly diagnosed AA or GBM and may improve progression-free survival (PFS) and overall survival (OS).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject is a male or female 18 years of age or older.
. Subject is undergoing planned resection of known or suspected GBM.
. Subject has a Karnofsky Performance Status (KPS) 70% or greater.
. Subject has a life expectancy of at least 6 months, in the opinion of the Investigator.
. Based on the pre-operative evaluation by neurosurgeon, the subject is a candidate for ≥ 80% resection of enhancing region.
. Subject must be able to undergo MRI evaluation.
. Subject meets the following laboratory criteria:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Subject, if female, is pregnant or is breast feeding.
. Subject has initiated chemotherapy or radiation treatment for diagnosis of or GBM.
. Subject intends to participate in another clinical trial
. Subject intends to undergo treatment with the Gliadel® wafer at the time of this surgery.
. Subject has an active infection requiring treatment.
. Subject has radiographic evidence of multi-focal disease or leptomeningeal dissemination.
. Subject has a history of other malignancy, unless the patient has been disease- free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ after curative treatment
. Subject has a known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection.