Improving Understanding of Brain Tumors Through Preservation of Biologically Active Brain Tissue

NCT04545177 | Active Not Recruiting FDA Device

• 1 other identifier: CASE8319
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Recent experiments are giving researchers insight into the changes (mutations) that occur in an individual brain tumor cell compared to a normal cell. Currently, we do not have enough knowledge about how uniform these changes are throughout a single brain tumor and if different regions of a brain tumor have different groupings of changes. By obtaining multiple samples of the tumor from various regions during surgery, it will allow researchers to better understand these changes, with the hope that they will lead to new discoveries in the diagnosis and treatment of brain tumors.

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Feasibility, as measured by percentage of the sample deemed viable by flow cytometry

  Flow cytometry will be performed to quantify viable cells in a cell suspension. This will be reported as a percentage of live cells of the population

  1 year

Other Outcomes (3)

• Number of somatic mutations per region

  1 year

• Gene expression in tumor regions

  1 year

• DNA methylation status in tumor regions

  1 year

Study Arms (1)

Tissue Preservation System (TPS)

EXPERIMENTAL

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)

Device: NICO Myriad and Tissue Preservation System (TPS)

Interventions

NICO Myriad and Tissue Preservation System (TPS) DEVICE

Tumor tissue will be obtained by the NICO Myriad and Tissue Preservation System (TPS) via an automated, standardized methodology

Tissue Preservation System (TPS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) OR
• 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
• Contrast-enhancing tumor volume of at least 15 cc on the preoperative, volumetric MRI within 1 month prior to surgery
• Karnofsky performance status of 70 or higher
• The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
• Screening/Baseline laboratory values must meet the following criteria within 1 month prior to surgery:
• Hematological
• Absolute neutrophil count (ANC): ≥ 1500/µL
• Platelets ≥100 000/µL
• Hemoglobin ≥ 9.0 g/dL or ≥5.6 mmol/L ----Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.
• Renal
• Creatinine OR Measured or calculated creatinine clearance (glomerular filtration rate (GFR) can also be used in place of creatinine or CrCl) ≤ 1.5 × ULN OR ≥30 mL/min for participant with creatinine levels \>1.5 × institutional ULN
• Creatinine clearance (CrCl) should be calculated per institutional standard.
• Coagulation
• International normalized ratio (INR) OR prothrombin time (PT). Activated partial thromboplastin time (aPTT) ≤ 1.5 × upper limit of normal (ULN) unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants

You may not qualify if:

• 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.
• Is pregnant.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Alireza Mohammadi, MD

  Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: September 10, 2020
• Study Start: September 17, 2020
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)