Omental Tissue Autograft for Recurrent Glioblastoma Multiforme
This study is testing a procedure called laparoscopically harvested omental tissue autograft for people with recurrent glioblastoma multiforme (rGBM), a type of aggressive brain tumor. After standard surgery to remove the tumor, fat tissue from your abdomen (called omentum) is taken out using a thin tube with a camera (laparoscopically). This omental fat is then placed into the brain tumor cavity. The main goal is to see how safe this procedure is, specifically looking at whether it causes rapid disease progression, increased seizures, stroke, or infection within 180 days. This study is open to adults aged 18 and older who are planning to have surgery for GBM, have a good performance status (Karnofsky Performance Status of 70% or higher), and are expected to live at least 6 months. The study is currently unclear on its recruitment status and plans to enroll 10 participants.
- Study design
- This is a single-center, single-arm, open-label study that will enroll 10 participants to assess the safety of the intervention.
- What's involved
- You would undergo standard tumor removal surgery, a laparoscopic procedure to harvest omental tissue, and then implantation of this tissue into the brain tumor cavity. Safety will be monitored for 180 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety parameters from Study Day 1 to Day 180 after the procedure.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Omental Tissue Autograft in Human Recurrent Glioblastoma Multiforme (rGBM)
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- John Boockvar, MD · PRINCIPAL_INVESTIGATOR · Northwell Health
Who to contact
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What this trial measures
- Safety parameter: proportion of patients experiencing rapidly progressive disease as indicated by MRI using RANO Criteria harvested omental graft for recurrent glioblastoma multiforme (rGBM).Study Day 1 - Day 180
Increase in tumor size relative to baseline will be measured using RANO and assessed by MRI throughout study at within 72 hours, 7 days, 30 days, 60 days, 120 days and 180 days. Rapidly progressive disease is defined as 25% growth relative to baseline.
- Safety parameter: proportion of patients experiencing increase in seizures, stroke, and infection.Study Day 1 - Day 180
Increase in seizures (defined as 15% relative to baseline), occurrence of a stroke, or occurrence of a severe infection will be determined throughout study within 72 hours, 7 days, 30 days, 60 days, 120 days and 180 days.