NCT04545177Active, not recruiting
Improving Understanding of Brain Tumors Through Preservation of Biologically Active Brain Tissue
Prospective Surgical Study on the Feasibility of Semi-Automated Tissue Collection, Stabilization, Preservation, and Site Transfer - Improving Understanding of Brain Tumors Through Preservation of Biologically Active Brain Tissue
Source: ClinicalTrials.gov · Last updated 8 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 18 (actual)
- First submitted
- 17 Mar 2020
- Start date
- 17 Sept 2020
- Primary completion date
- Dec 2026
- Lead sponsor
- Case Comprehensive Cancer Center
- Diseases
- Glioblastoma
- NCT number
- NCT04545177
What you commit to
- Study type: Interventional
- Participants enrolled: 18
- From 17 Sept 2020 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Lab values
- 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.
Other
- Is pregnant.
Who the study is looking for
- 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
- Miscellaneous
- Urine or Serum Pregnancy Test ----Negative (Not applicable to patients with bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.