Tissue Preservation for Glioblastoma

Overseen By Alireza Mohammadi, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Psychiatric disorders, Substance abuse, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how brain tumors, specifically glioblastoma, differ at the cellular level by collecting tissue samples from various tumor parts during surgery. The research aims to understand the genetic changes within these tumors, potentially leading to better diagnosis and treatment options. Participants with high-grade glioma seen on MRI scans or those with a confirmed diagnosis of recurrent glioblastoma requiring surgery might be suitable candidates. The trial employs the NICO Myriad and Tissue Preservation System (TPS) to collect and analyze the tissue. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve future glioblastoma treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the NICO Myriad and Tissue Preservation System is safe for tissue preservation?

Research has shown that the NICO Myriad and Tissue Preservation System (TPS) have been used safely in various studies. The NICO Myriad is a tool that removes tissue without damaging it. Surgeons have used it to take tumor samples without affecting nearby tissue, indicating it is well-tolerated during procedures.

In one study, researchers used the NICO Myriad to collect tissue from patients with glioblastoma, a type of brain tumor. The collected tissue remained intact and useful for further testing, demonstrating the system's safety and effectiveness in preserving tissue for research.

The FDA has approved the NICO Myriad for its intended use, confirming it meets specific safety standards and making it a reliable choice for research and surgeries. Overall, studies suggest that using the NICO Myriad and TPS is safe for collecting and preserving brain tumor tissue. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Tissue Preservation System (TPS) for glioblastoma because it offers a new way to analyze tumor samples at a molecular level. Unlike traditional treatments that mainly focus on surgically removing tumors or targeting them with chemotherapy and radiation, TPS processes tumor tissue to allow for advanced genetic and cellular analyses. This method can uncover specific genetic mutations and expression profiles, potentially leading to more personalized and effective treatment strategies. By understanding the tumor's unique genetic makeup, TPS could pave the way for targeted therapies that are more precise and tailored to each individual's cancer.

What evidence suggests that the NICO Myriad and Tissue Preservation System is effective for glioblastoma?

Research has shown that the NICO Myriad and Tissue Preservation System (TPS), used by participants in this trial, can collect brain tumor tissue without causing damage. Studies have found that tissue collected with this system remains in better condition compared to other methods. As a result, the tissue stays alive and intact longer, which is crucial for accurate testing and analysis. In earlier research, tumor tissues from patients with glioblastoma (a type of brain cancer) remained viable for various genetic and cellular tests. This aids researchers in understanding brain tumors, potentially leading to new treatments. ^{1 2 3 4 6}

Who Is on the Research Team?

Alireza Mohammadi, MD

Principal Investigator

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with a high-grade brain tumor called glioblastoma, visible on MRI scans. They must have a significant amount of tumor tissue (at least 15 cc), be in good physical condition (Karnofsky score ≥70), and have normal blood, kidney, and coagulation lab values. Pregnant individuals or those with conditions that could affect the study's outcome are excluded.

Inclusion Criteria

Participants who have the appearance of high grade glioma on MR imaging are allowed to consent and will undergo the procedure if the frozen is consistent with World Health Organization Grade IV glioma (glioblastoma or gliosarcoma)

Contrast-enhancing tumor volume of at least 15 cc on the preoperative, volumetric MRI within 1 month prior to surgery

Participants with a history of histologically-confirmed diagnosis of World Health Organization Grade IV glioma (glioblastoma or gliosarcoma) that are undergoing repeat resection of a recurrent tumor as identified on preoperative MR imaging

Exclusion Criteria

Is pregnant.

Has a history or current evidence of any medical condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.

Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Tissue Collection

Tumor tissue is obtained, processed, and transported for analysis using the NICO Myriad and Tissue Preservation System (TPS)

1 day

1 visit (in-person)

Analysis and Monitoring

Tumor samples undergo multiple tests including gene panel DNA sequencing, DNA methylation array, and RNA-seq analyses

1 year

Follow-up

Participants are monitored for safety and effectiveness after tissue collection and analysis

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NICO Myriad and Tissue Preservation System (TPS)

Trial Overview The trial is using the NICO Myriad device and Tissue Preservation System to collect multiple samples from different areas of brain tumors during surgery. The goal is to understand how mutations vary within the tumor which may improve diagnosis and treatment strategies.

How Is the Trial Designed?

Group I: Tissue Preservation System (TPS) Experimental Treatment 1 Intervention

Tumor tissue will be obtained, processed, and then transported remotely to undergo multiple tests, including gene panel DNA sequencing, DNA methylation array, and bulk as well as single-cell transcriptome analyses (RNA-seq)

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6843001/

Tissues Harvested Using an Automated Surgical Approach ... The NICO Myriad™ System (NICO Corporation, Indianapolis, IN) is a multi-functional, non-ablative, targetable tissue resection tool used for ...

2. niconeuro.com niconeuro.com/news/nico-awards-180k-grant-to-study-gbm-progression-using-novel-longitudinal-serial-sampling-in-translational-research/

NICO Awards $180000 Grant to Study GBM Progression ... The study uses the new NICO Myriad® Research Laboratory System to safely and progressively sample intracranial tissue over time in murine models ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S187887502200033X

Establishing a Standardized Method for the Effective ... Our results showed that primary GB cell cultures derived in this manner had improved growth over widely used collection and preservation methods. By ...

4. niconeuro.com niconeuro.com/wp-content/uploads/2023/03/LIT597RevA_Manmeet-IIS-PRESERV-GBM_FINAL_230314.pdf

New GBM Study PRESERVE Receives ... His earlier work assessed the viability, volume and integrity of tumor tissue after collection in 20 patients with glioblastoma using the NICO ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11456923/

Toward standardized brain tumor tissue processing protocols ... For example, the NICO Myriad/APS System (NICO Corporation, Indianapolis, IN) is a multi-functional, non-ablative, tissue resection device ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10029063/

Spatial immunosampling of MRI-defined glioblastoma regions ... Annotated regions were localized and the tissue surgically harvested by the neurosurgeon using the navigable NICO Myriad™, an FDA cleared suction/microscissor ...