[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06090903":3,"trial-entities:NCT06090903":120,"trial-summary:NCT06090903":123},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":63,"secondary_outcomes":77,"sex":81,"minimum_age":82,"maximum_age":83,"healthy_volunteers":84,"eligibility_criteria":85,"std_ages":93,"locations":96,"central_contacts":114,"overall_officials":115,"references":118,"see_also_links":119},"NCT06090903","21-002112","Magnetic Resonance Imaging for Improving Knowledge of Brain Tumor Biology in Patients With Resectable Glioblastoma","Exploration Into the Association Between Decorin (DCN) Expression and MR Phenotypes in GBM","RECRUITING","2028-04-18","2025-11","2025-11-10","2022-04-14","Jonsson Comprehensive Cancer Center","OTHER",true,"This clinical trial uses a type of imaging scan called magnetic resonance imaging (MRI) to study brain tumor biology in patients with glioblastoma that can be removed by surgery (resectable). Malignant gliomas are the second leading cause of cancer mortality in people under the age of 35 in the United States. Glioblastoma is a type of malignant glioma with very poor patient prognosis. There are currently only about 3 drugs approved by the Food and Drug Administration (FDA) for the treatment of glioblastoma, one of them being administration of bevacizumab, which is very expensive. It is the most widely used treatment for glioblastoma with dramatic results. However, previous clinical trials have not demonstrated an overall survival benefit across all patient populations with glioblastoma that has returned after treatment (recurrent). The study aims to identify which patients who will benefit from bevacizumab therapy by observing MRI images and corresponding imaging biomarkers.","PRIMARY OBJECTIVES:\n\nI. Enhancing tumors with high diffusion measurements (low apparent diffusion coefficient \\[ADCL\\] \\> 1.24 um\\^2\u002Fms) will have higher DCN protein expression compared with tumors exhibiting low diffusion measurements (ADCL \\\u003C 1.24 um\\^2\u002Fms.) (Aim 1A) II. Enhancing tumors with high diffusion measurements (low apparent diffusion coefficient \\[ADCL\\] \\> 1.24 um\\^2\u002Fms) will have higher deoxyribonucleic acid (DNA) expression compared with tumors exhibiting low diffusion measurements (ADCL \\\u003C 1.24 um\\^2\u002Fms.) (Aim 1B) III. Enhancing tumors with high diffusion measurements (low apparent diffusion coefficient \\[ADCL\\] \\> 1.24 um\\^2\u002Fms) will have higher ribonucleic acid (RNA) expression compared with tumors exhibiting low diffusion measurements (ADCL \\\u003C 1.24 um\\^2\u002Fms.) (Aim 1C) IV. Mesenchymal-Like (MES-like) cells will have higher frequency of incidence of tumors with high diffusion measurements (ADCL \\> 1.24 um\\^2\u002Fms) and higher overall DCN expression levels compared to other genotypes.\n\nSECONDARY OBJECTIVE:\n\nI. DCN immunohistochemistry (IHC), in-situ hybridization (ISH), and RNA expression within the tumor will be linearly correlated with continuous values of diffusion measurements (ADCL).\n\nOUTLINE:\n\nPatients undergo one MRI scan over approximately 1 hour prior to surgery.",[19,20,21],"Glioblastoma","Recurrent Glioblastoma","Resectable Glioblastoma",[],"INTERVENTIONAL","SCREENING",[26],"NA",{"count":28,"type":29},50,"ESTIMATED",[31,41,57],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":37},"PROCEDURE","Biospecimen Collection","patients will receive 1-3 image-guided biopsies within tumor tissue already designated for resection or removal.",[36],"Screening (MRI)",[38,39,40],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",{"type":32,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"Magnetic Resonance Imaging","Undergo MRI scan",[36],[46,47,48,49,50,51,52,53,54,55,56],"Magnetic Resonance","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging",{"type":14,"name":58,"description":59,"armGroupLabels":60,"otherNames":61},"Medical Chart Review","Review Medical Chart",[36],[62],"Chart Review",[64,68,71,74],{"measure":65,"description":66,"timeFrame":67},"Decorin (DCN) expression","Will use a two-sided t-test to compare DCN immunohistochemistry (IHC), in-situ hybridization (ISH), and ribonucleic acid (RNA) sequencing positivity between low apparent diffusion coefficient (ADCL) \\\u003C 1.24 um\\^2\u002Fms and ADCL \\> 1.24 um2\u002Fms groups.","Up to 5 years",{"measure":69,"description":70,"timeFrame":67},"DCN expression correlated to ADCL","Will assess whether DCN IHC, ISH, and RNA expression within the tumor is linearly correlated with continuous values of ADCL. To test this, will examine Pearson's correlation coefficient (R\\^2) and test whether the slope of the linear regression line is significantly different from zero. After purification, will also quantify the particular genotype or cell states represented by tumor cells for each ADCL phenotype.",{"measure":72,"description":73,"timeFrame":67},"Incidence of tumors with high diffusion measurements among MES-like cells","Will assess whether MES-like cells have higher frequency of incidence of ADCL \\> 1.24 um\\^2\u002Fms compared to other genotypes. To test this, will use a chi-squared goodness of fit test to assess the frequency of observations and an analysis of variance (ANOVA) to look at DCN protein, deoxyribonucleic acid (DNA), and RNA expression between genotypes.",{"measure":75,"description":76,"timeFrame":67},"DCN expression among Mesenchymal-Like (MES-like) cells","Will assess whether MES-like cells have higher overall DCN expression levels compared to other genotypes. To test this, will use a chi-squared goodness of fit test to assess the frequency of observations and an ANOVA to look at DCN protein, DNA, and RNA expression between genotypes.",[78],{"measure":79,"description":80,"timeFrame":67},"DCN protein concentration in blood plasma","Will compare DCN protein concentration in blood plasma and use a two-sided t-test to compare DCN concentration between ADCL \\\u003C 1.24 um\\^2\u002Fms and ADCL \\> 1.24 um\\^2\u002Fms cohorts. We will also test whether blood plasma concentrations of DCN are linearly correlated with tumor IHC levels using Pearson's correlation coefficient (R\\^2) and test whether the slope of the linear regression line is significantly different from zero.","ALL","18 Years",null,false,{"inclusion":86,"exclusion":89,"raw_text":92},[87,88],"Patients \\> 18 years of age","Patients with newly diagnosed, suspected or recurrent glioblastoma (GBM) patients with enhancing tumors greater than 1.5 mL clinically indicated for surgical resection. Recurrent GBM must have occurred more than 3 months after the end of radiation therapy per Response Assessment in Neuro-Oncology Criteria (RANO) guidelines",[90,91],"Counterindication to magnetic resonance imaging (MRI) (Patient has a pacemaker or metal in the body)","Patients \\\u003C 18 years of age","Inclusion Criteria:\n\n* Patients \\> 18 years of age\n* Patients with newly diagnosed, suspected or recurrent glioblastoma (GBM) patients with enhancing tumors greater than 1.5 mL clinically indicated for surgical resection. Recurrent GBM must have occurred more than 3 months after the end of radiation therapy per Response Assessment in Neuro-Oncology Criteria (RANO) guidelines\n\nExclusion Criteria:\n\n* Counterindication to magnetic resonance imaging (MRI) (Patient has a pacemaker or metal in the body)\n* Patients \\\u003C 18 years of age",[94,95],"ADULT","OLDER_ADULT",[97],{"facility":98,"status":8,"city":99,"state":100,"zip":101,"country":102,"contacts":103,"geoPoint":111},"UCLA \u002F Jonsson Comprehensive Cancer Center","Los Angeles","California","90095","United States",[104,109],{"name":105,"role":106,"phone":107,"email":108},"Benjamin M. Ellingson","CONTACT","310-481-7572","bellingson@mednet.ucla.edu",{"name":105,"role":110},"PRINCIPAL_INVESTIGATOR",{"lat":112,"lon":113},34.05223,-118.24368,[],[116],{"name":117,"affiliation":98,"role":110},"Benjamin M Ellingson",[],[],{"nct_id":4,"conditions":121,"biomarkers":122},[19],[],{"nct_id":4,"found":15,"summary":124,"prompt_version":134},{"design":125,"status":126,"heading":127,"summary":128,"follow_up":129,"word_count":130,"commitments":131,"compensation":132,"drugs_mentioned":133},"This is an interventional study with a planned enrollment of 50 participants. It is not specified if it is randomized or blinded.","completed","MRI for Understanding Glioblastoma Biology","This study is looking at how Magnetic Resonance Imaging (MRI) can help us better understand glioblastoma, a type of brain tumor that can be removed by surgery. Researchers want to see if specific measurements from MRI scans can tell us more about the tumor's biology, specifically about certain proteins (like Decorin, or DCN) and genetic material (DNA and RNA) within the tumor. This could lead to better ways to understand and treat glioblastoma. You might be able to join if you are over 18 and have newly diagnosed or recurrent glioblastoma that can be surgically removed. The study aims to enroll 50 participants, but its current recruitment status is unclear.","Researchers will look at certain measurements for up to 5 years after you join the study.",110,"You would undergo one MRI scan before surgery, and researchers would collect tissue samples from your tumor during surgery. Your medical chart would also be reviewed.","Not stated in the trial record.",[42],"v2"]