RecruitingNot ApplicableNCT05979064

Omental Tissue Autograft in Human Recurrent Glioblastoma Multiforme (rGBM)

Laparoscopically Harvested Omental Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Recurrent Glioblastoma Multiforme (rGBM)


Sponsor

Northwell Health

Enrollment

10 participants

Start Date

Apr 4, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This single center, single arm, open-label, phase I study will assess the safety of laparoscopically harvested autologous omentum, implanted into the resection cavity of recurrent glioblastoma multiforme (GBM) patients.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether placing a small piece of omental tissue (fat from inside the abdomen) into the brain at the time of surgery helps improve outcomes for people with recurrent glioblastoma (GBM), a highly aggressive brain tumor that has grown back after previous treatment. **You may be eligible if...** - You are 18 or older - You are having surgery to remove a recurrent glioblastoma - You are in reasonable health (Karnofsky score 70% or above) - Surgeons expect to remove at least 80% of the visible tumor - Your blood counts, liver function, and bilirubin are within acceptable limits - You are expected to survive at least 6 months **You may NOT be eligible if...** - You have had too many prior surgeries or treatments that make this procedure unsafe - Your overall health does not support surgery - You are unable to undergo MRI Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURELaparoscopically harvested omental tissue autograft

1. Standard neurosurgical removal of recurrent GBM, 2. removal of fat from abdomen called omentum using a thin tube with a camera (laparoscopically), 3. the omental fat will be transferred and implanted into brain tumor cavity, 4. standard closure of surgical resection cavity.


Locations(1)

Lenox Hill Brain Tumor Center

New York, New York, United States

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NCT05979064


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