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

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial uses a special tool to collect and preserve brain tumor samples from patients with Glioblastoma. The goal is to understand the different changes in various parts of the tumor, which could help improve diagnosis and treatment.

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.

Is the NICO Myriad or Tissue Preservation System (TPS) safe for use in humans?

The NICO Myriad system, used for tissue harvesting in glioblastoma, has been shown to produce samples with similar growth and tumorigenic potential as traditional methods, suggesting it is safe for use in humans. Additionally, cryopreservation methods for glioblastoma tissue have been well tolerated, indicating that these preservation techniques are generally safe. ^{1 2 3 4 5}

How does the NICO Myriad and Tissue Preservation System treatment for glioblastoma differ from other treatments?

The NICO Myriad and Tissue Preservation System is unique because it uses an automated surgical approach to better access the invasive parts of glioblastoma tumors, allowing for more precise tissue collection. This method enhances the quality of tissue samples for research, potentially leading to more effective individualized therapies by capturing the tumor's molecular diversity. ^{2 4 6 7 8}

What data supports the effectiveness of the treatment NICO Myriad and Tissue Preservation System (TPS) for glioblastoma?

The NICO Myriad system, used for obtaining glioblastoma tissue, helps capture the molecular diversity of the tumor, which can improve the design and effectiveness of personalized therapies. This approach allows for better profiling of the tumor's genetic makeup, potentially leading to more targeted and effective treatments. ^{2 4 6 9 10}

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. Switzerland pubmed.ncbi.nlm.nih.gov

Tissues Harvested Using an Automated Surgical Approach Confirm Molecular Heterogeneity of Glioblastoma and Enhance Specimen's Translational Research Value. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Optimization of high grade glioma cell culture from surgical specimens for use in clinically relevant animal models and 3D immunochemistry. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Establishment and characterization of primary glioblastoma cell lines from fresh and frozen material: a detailed comparison. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Organotypic slice cultures of human glioblastoma reveal different susceptibilities to treatments. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Label-free microscopic assessment of glioblastoma biopsy specimens prior to biobanking [corrected]. [2014]

6. England pubmed.ncbi.nlm.nih.gov

Cryopreservation of viable human glioblastoma xenografts. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Validation of a postfixation tissue storage and transport medium to preserve histopathology and molecular pathology analyses (total and phosphoactivated proteins, and FISH). [2019]

8. England pubmed.ncbi.nlm.nih.gov

Primary glioma spheroids maintain tumourogenicity and essential phenotypic traits after cryopreservation. [2006]

9. England pubmed.ncbi.nlm.nih.gov

Clinical and research applications of a brain tumor tissue bank in the age of precision medicine. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Establishing a Standardized Method for the Effective Intraoperative Collection and Biological Preservation of Brain Tumor Tissue Samples Using a Novel Tissue Preservation System: A Pilot Study. [2022]