GliomaNCT05979064
Omental Tissue Autograft in Human Recurrent Glioblastoma Multiforme (rGBM)
A study testing Laparoscopically harvested omental tissue autograft in people with Glioma and Glioma, Malignant, run by Northwell Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Glioma, Malignant, Glioblastoma
- What is being tested?
- Laparoscopically harvested omental tissue autograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2023to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Subject meets the following laboratory criteria:
- White blood count ≥ 3,000/μL
- Absolute neutrophil count ≥ 1,500/μL
- Platelets ≥ 100,000/μL
- Hemoglobin > 10.0 g/dL (transfusion and/or ESA allowed)
- Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x ULN
- Blood urea nitrogen (BUN) and creatinine < 1.5 x ULN
- Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control.
- Able to understand and willing to sign an institutional review board (IRB)- approved written informed consent document
- Subject has a histologically confirmed (frozen section) diagnosis of recurrent WHO Grade IV glioblastoma multiforme (GBM).
- Omental graft is technically feasible.
Who cannot join
- Subject, if female, is pregnant or is breast feeding.
- 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
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- Subject has a known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection.
- Subject has a history or evidence of any other clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
- Subject has had prior abdominal surgery that in the opinion of the general surgeon makes removal of omentum more risky or inadequate.
- Subject has severe renal insufficiency rendering gadolinium MRI contraindicated.
- Subject who are unable to have an MRI scan for any reason.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Lenox Hill Brain Tumor Center
New York, New York, 10075
John Boockvar, MD, 212-434-3900, jboockvar@northwell.edu
Tamika Wong, MPH, 212-434-4836, twong4@northwell.edu
About this study
Official title: Laparoscopically Harvested Omental Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Recurrent Glioblastoma Multiforme (rGBM)
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.
Read the detailed description
Laparoscopically harvested omental grafts are commonly used to fill surgical cavities after resection of head and neck cancers. Investigators hypothesize that an omental tissue graft implanted into our patients with resected recurrent GBM may be used as a readily available and accessible means of circumventing the blood brain barrier (BBB) selectively and focally. The laparoscopically harvested omental graft omentum would easily conform to many resected GBM cavities in our human patients with acceptable risk. The predictable and rich vascular anatomy of a laparoscopically harvested piece of omentum makes it an ideal tissue for cases of previously irradiated and/or infected wound beds. This is why it is successfully used in head and neck and skull base tumors. The permeability of the new blood vessels formed between the omental graft and the cortical brain surface should allow for improved delivery of chemotherapeutics and immune cells (macrophages and T cells) into the vicinity, extracellular space and microenvironment of the resected tumor cavity including the brain adjacent to the tumor (BAT). Milky spots within the greater omentum are very small white-coloured areas of lymphoid tissue will also provide direct deposition of immune cells such as dendritic, macrophages and lymphocytes into the milieu of the resected GBM. The milky spots are made up of mesenchymal cells and are covered in a layer of mesothelium. These structures surround the small blood vessels. The enclosing mesothelium contains macrophages, lymphocytes and mast cells. They are also known as secondary lymphoid organs. Most milky spots contain extremely thin-walled lymphatic capillaries. In addition, the technique of fat grafting has been reliably used since 1990 as a way to improve and enhance wound healing, scar healing, as well as tissue augmentation and tissue repair following radiation injury.
All subjects included in the study will undergo standard surgical resection for diagnosed recurrent GBM. Following the resection, the surgical cavity will be lined with a laparoscopically harvested piece of autologous omentum. The patient's dura, bone and scalp will be closed as is customary. The subject will be followed for side effects within 72 hours, 7 days, 30 days, 60 days, 120 days and 180 days. Risk assessment will include seizure, stroke, infection, tumor progression, and death.
The investigators aim to prove that this commonly surgical technique for head and neck cancers and reconstructive surgery is safe in a small human cohort of patients with resected recurrent GBM and may improve progression-free survival (PFS) and overall survival (OS).
- Conditions
- Glioma, Glioma, Malignant, Glioblastoma, Glioblastoma Multiforme, Glioblastoma Multiforme of Brain, GBM
- Being tested
- Laparoscopically harvested omental tissue autograft
- Keywords
- blood brain barrier, omentum autograft, omental autograft, omentum, omental
- Medical subject headings
- Glioma, Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopically harvested omental tissue autograftProcedure or surgery
- Standard neurosurgical removal of recurrent GBM,
- removal of fat from abdomen called omentum using a thin tube with a camera (laparoscopically),
- the omental fat will be transferred and implanted into brain tumor cavity,
- standard closure of surgical resection cavity.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopically harvested omental tissue autograft | Experimental | Use of laparoscopically harvested omental autografts into the resection cavity of recurrent glioblastoma multiforme (rGBM) patients. Receives: Procedure: Laparoscopically harvested omental tissue autograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety parameter: proportion of patients experiencing rapidly progressive disease as indicated by MRI using RANO Criteria harvested omental graft for recurrent glioblastoma multiforme (rGBM).
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.
Measured: Study Day 1 - Day 180
Safety parameter: proportion of patients experiencing increase in seizures, stroke, and infection.
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.
Measured: Study Day 1 - Day 180
Secondary outcomes (3)
Progression Free Survival (PFS)
The proportion of patients who are alive at 6 months from omental implantation and are progression-free will be estimated using standard methods for proportions, along with the associated exact 95% confidence interval.
Measured: 6 months
Overall Survival (OS)
OS will be calculated as the time from treatment initiation (omental autograft) to the time of death.
Measured: 6 months
Percent of screen fails
To tabulate the number and % of screen failures and understand the reason for screen failures (omental autograft not viable etc.) will be tabulated and summarized.
Measured: Study Day 1 - 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start4 Apr 2023
- Primary completionApr 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Boockvar, MD Zucker SOM @Hofstra/Northwell, Northwell Health
- Investigators
- John Boockvar, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979064
- Sponsor's protocol ID
- 22-0994
- Status last verified
- May 2026
- First submitted
- 31 Jul 2023
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopically Harvested Omental Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Recurrent Glioblastoma Multiforme (rGBM)
- ClinicalTrials.gov ID
- NCT05979064
- Acronym / sponsor ID
- 22-0994
- Conditions
- Glioma, Glioma, Malignant, Glioblastoma, Glioblastoma Multiforme, Glioblastoma Multiforme of Brain, GBM
- Keywords
- blood brain barrier, omentum autograft, omental autograft, omentum, omental
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Laparoscopically harvested omental grafts are commonly used to fill surgical cavities after resection of head and neck cancers. Investigators hypothesize that an omental tissue graft implanted into our patients with resected recurrent GBM may be used as a readily available and accessible means of circumventing the blood brain barrier (BBB) selectively and focally. The laparoscopically harvested omental graft omentum would easily conform to many resected GBM cavities in our human patients with acceptable risk. The predictable and rich vascular anatomy of a laparoscopically harvested piece of omentum makes it an ideal tissue for cases of previously irradiated and/or infected wound beds. This is why it is successfully used in head and neck and skull base tumors. The permeability of the new blood vessels formed between the omental graft and the cortical brain surface should allow for improved delivery of chemotherapeutics and immune cells (macrophages and T cells) into the vicinity, extracellular space and microenvironment of the resected tumor cavity including the brain adjacent to the tumor (BAT). Milky spots within the greater omentum are very small white-coloured areas of lymphoid tissue will also provide direct deposition of immune cells such as dendritic, macrophages and lymphocytes into the milieu of the resected GBM. The milky spots are made up of mesenchymal cells and are covered in a layer of mesothelium. These structures surround the small blood vessels. The enclosing mesothelium contains macrophages, lymphocytes and mast cells. They are also known as secondary lymphoid organs. Most milky spots contain extremely thin-walled lymphatic capillaries. In addition, the technique of fat grafting has been reliably used since 1990 as a way to improve and enhance wound healing, scar healing, as well as tissue augmentation and tissue repair following radiation injury.
All subjects included in the study will undergo standard surgical resection for diagnosed recurrent GBM. Following the resection, the surgical cavity will be lined with a laparoscopically harvested piece of autologous omentum. The patient's dura, bone and scalp will be closed as is customary. The subject will be followed for side effects within 72 hours, 7 days, 30 days, 60 days, 120 days and 180 days. Risk assessment will include seizure, stroke, infection, tumor progression, and death.
The investigators aim to prove that this commonly surgical technique for head and neck cancers and reconstructive surgery is safe in a small human cohort of patients with resected recurrent GBM and may improve progression-free survival (PFS) and overall survival (OS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopically harvested omental tissue autograft | Experimental | Procedure: Laparoscopically harvested omental tissue autograftUse of laparoscopically harvested omental autografts into the resection cavity of recurrent glioblastoma multiforme (rGBM) patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (11 listed)
- Subject, if female, is pregnant or is breast feeding.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopically harvested omental tissue autograft1. 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. | Procedure or surgery | Laparoscopically harvested omental tissue autograft |
Primary outcome
Safety parameter: proportion of patients experiencing rapidly progressive disease as indicated by MRI using RANO Criteria harvested omental graft for recurrent glioblastoma multiforme (rGBM).
Time frame: 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.
Time frame: 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.
3 secondary outcomes
Progression Free Survival (PFS)
Time frame: 6 months
Overall Survival (OS)
Time frame: 6 months
Percent of screen fails
Time frame: Study Day 1 - 24 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Boockvar, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopically harvested omental tissue autograft in people with Glioma and Glioma, Malignant, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Boockvar, MD (212-434-3900, jboockvar@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety parameter: proportion of patients experiencing rapidly progressive disease as indicated by MRI using RANO Criteria harvested omental graft for recurrent glioblastoma multiforme (rGBM). (time frame: Study Day 1 - Day 180). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.