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Procedure
Omental Tissue Autograft for Brain Tumor
N/A
Recruiting
Led By John Boockvar, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial tests if it's safe to use a patient's own omentum to treat recurrent GBM tumors after surgery.
Who is the study for?
This trial is for adults over 18 with recurrent Grade IV glioblastoma multiforme (GBM) who are candidates for significant tumor resection and can undergo MRI scans. They must have a life expectancy of at least 6 months, meet specific lab criteria, and not be pregnant or breastfeeding. Exclusions include active infections, other clinical trials participation, prior abdominal surgery, or severe renal issues.Check my eligibility
What is being tested?
The study tests the safety of implanting laparoscopically harvested autologous omentum tissue into the cavity after GBM tumor resection. It's an early-phase trial to see if this approach is safe in patients with recurrent brain tumors.See study design
What are the potential side effects?
While specific side effects aren't listed here, potential risks may include complications from laparoscopic surgery such as infection or bleeding, reaction to anesthesia, and any unforeseen impacts of introducing omental tissue into the brain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety parameter: proportion of patients experiencing increase in seizures, stroke, and infection.
Safety parameter: proportion of patients experiencing rapidly progressive disease as indicated by MRI using RANO Criteria harvested omental graft for recurrent glioblastoma multiforme (rGBM).
Secondary outcome measures
Overall Survival (OS)
Percent of screen fails
Progression Free Survival (PFS)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Laparoscopically harvested omental tissue autograftExperimental Treatment1 Intervention
Use of laparoscopically harvested omental autografts into the resection cavity of recurrent glioblastoma multiforme (rGBM) patients.
Find a Location
Who is running the clinical trial?
Northwell HealthLead Sponsor
460 Previous Clinical Trials
471,033 Total Patients Enrolled
John Boockvar, MDPrincipal InvestigatorNorthwell Health
13 Previous Clinical Trials
815 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for surgery to remove a brain tumor suspected to be GBM.I am mostly independent and can care for myself.I am currently being treated for an infection.I cannot have MRI scans with gadolinium due to severe kidney problems.I don't have any health conditions that could risk my safety or affect the study.I have had surgery in my abdomen before.I am 18 years old or older.I am currently pregnant or breastfeeding.My neurosurgeon believes they can remove most of my tumor.I plan to receive Gliadel wafer treatment during my surgery.My scans show cancer has spread to multiple areas or the lining of my brain/spine.I've been cancer-free for 5 years, except for certain skin, prostate, or cervical cancers.My surgery confirmed I have recurrent Grade IV brain cancer, and an omental graft is possible.
Research Study Groups:
This trial has the following groups:- Group 1: Laparoscopically harvested omental tissue autograft
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities for participants to join this experiment?
"Currently, the trial is in its recruitment period. As attested by clinicaltrials.gov, this study was published on April 4th 2023 and underwent a most recent update on July 31st of the same year."
Answered by AI
What is the current enrollment quota for this clinical experiment?
"Affirmative. According to the clinicaltrials.gov database, this medical trial is recruiting candidates at present. It was initially published on April 4th 2023 and subsequently updated on July 31st of the same year. One single site needs to recruit 10 patients in total for the study's completion."
Answered by AI
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