Belly fat graft could outsmart brain Cancer's defenses
NCT ID NCT05979064
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tests if a piece of belly tissue placed in the brain during surgery can safely bypass the blood-brain barrier in people with recurrent glioblastoma, an aggressive brain cancer. Ten adults will be followed for 6 months to check for side effects like rapid tumor growth, seizures, or infection. The goal is to see if this approach is safe enough for further testing.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2023
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subject is a male or female 18 years of age or older. 2. Subject is undergoing planned resection of known or suspected GBM. 3. Subject has a Karnofsky Performance Status (KPS) 70% or greater. 4. Subject has a life expectancy of at least 6 months, in the opinion of the Investigator. 5. Based on the pre-operative evaluation by neurosurgeon, the subject is a candidate for ≥ 80% resection of enhancing region. 6. Subject must be able to undergo MRI evaluation. 7. Subject meets the following laboratory criteria: 1. White blood count ≥ 3,000/μL 2. Absolute neutrophil count ≥ 1,500/μL 3. Platelets ≥ 100,000/μL 4. Hemoglobin \> 10.0 g/dL (transfusion and/or ESA allowed) 5. Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of normal (ULN) 6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 x ULN 7. Blood urea nitrogen (BUN) and creatinine \< 1.5 x ULN 8. Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control. 9. Able to understand and willing to sign an institutional review board (IRB)- approved written informed consent document Inclusion criteria considered during surgery: 1. Subject has a histologically confirmed (frozen section) diagnosis of recurrent WHO Grade IV glioblastoma multiforme (GBM). 2. Omental graft is technically feasible. Exclusion Criteria: 1. Subject, if female, is pregnant or is breast feeding. 2. Subject intends to participate in another clinical trial. 3. Subject intends to undergo treatment with the Gliadel® wafer at the time of this surgery. 4. Subject has an active infection requiring treatment. 5. Subject has radiographic evidence of multi-focal disease or leptomeningeal dissemination. 6. 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 7. Subject has a known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection. 8. 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. 9. Subject has had prior abdominal surgery that in the opinion of the general surgeon makes removal of omentum more risky or inadequate. 10. Subject has severe renal insufficiency rendering gadolinium MRI contraindicated. 11. Subject who are unable to have an MRI scan for any reason.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Lenox Hill Brain Tumor Center
RECRUITINGNew York, New York, 10075, United States
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Other studies related to the condition(s) this trial covers.
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