[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03649880":3,"trial-entities:NCT03649880":152,"trial-summary:NCT03649880":155},{"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":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":85,"secondary_outcomes":94,"sex":99,"minimum_age":100,"maximum_age":101,"healthy_volunteers":102,"eligibility_criteria":103,"std_ages":127,"locations":130,"central_contacts":147,"overall_officials":148,"references":150,"see_also_links":151},"NCT03649880","STUDY00016043","Feasibility of FMISO in Brain Tumors","Feasibility of [¹⁸F]-Fluoromisonidazole (FMISO) in Assessment of Malignant Brain Tumors","RECRUITING","2030-01-31","2025-03","2025-03-25","2019-06-01","OHSU Knight Cancer Institute","OTHER",true,"This phase II trial studies how well ¹⁸F- fluoromisonidazole (FMISO) works with positron emission tomography (PET)\u002Fmagnetic resonance imaging (MRI) in assessing participants with malignant (cancerous) brain tumors. FMISO provides information about the oxygen levels in a tumor, which may affect how the tumor behaves. PET\u002FMRI imaging produces images of the brain and how the body functions. FMISO PET\u002FMRI may help investigators see how much oxygen is getting in the brain tumors.","PRIMARY OBJECTIVES:\n\nI. Determine the feasibility of obtaining ¹⁸F- fluoromisonidazole (FMISO) PET (hypoxic volume and tumor to blood background values \\[T\u002FB\\]) and dynamic susceptibility contrast enhanced (DSC) \\& diffusion-weighted imaging (DWI) MRI measures in patients with intracranial brain tumors.\n\nII. Determine if MRI contrast-enhancement and hypoxic volume are imaging profiles of glioblastoma immunotherapy-mediated pseudoprogression or true progression in a clinical trial.\n\nSECONDARY OBJECTIVE:\n\nI. Determine the feasibility of baseline and follow-up FMISO PET and MR imaging co-registration.\n\nTERTIARY OBJECTIVE:\n\nI. Determine the reproducibility of the baseline FMISO PET imaging metrics as assessed by baseline \"test\" and \"retest\" experiments.\n\nOUTLINE:\n\nParticipants receive FMISO intravenously (IV). Participants also undergo dynamic PET\u002Fcomputed tomography (CT) or PET\u002FMRI over 120 minutes beginning 1 minute prior to FMISO injection, and static PET\u002FCT or PET\u002FMRI over 20-40 minutes approximately 90 minutes after FMISO injection. Participants then undergo a retest examination within 7 days. Participants may undergo 2 more PET\u002FMRI or PET\u002FCT scans no sooner than every 4 weeks. Supplemental oxygen may be administered to effect MRI signal.\n\nAfter conclusion of the diagnostic tests, participants are followed for up to 5 years.",[19],"Malignant Brain Neoplasm",[],"INTERVENTIONAL","DIAGNOSTIC",[24],"PHASE2",{"count":26,"type":27},50,"ESTIMATED",[29,39,53,68,79],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":35},"DRUG","¹⁸F-Fluoromisonidazole","Given IV",[34],"Diagnostic (FMISO, PET\u002FMRI or PET\u002FCT)",[36,37,38],"¹⁸F-MISO","¹⁸F-Misonidazole","FMISO",{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"PROCEDURE","Computed Tomography","Undergo PET\u002FCT",[34],[45,46,47,48,49,50,51,52],"CAT","CAT Scan","Computerized Axial Tomography","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan","tomography",{"type":40,"name":54,"description":55,"armGroupLabels":56,"otherNames":57},"Magnetic Resonance Imaging","Undergo PET\u002FMRI or PET\u002FCT",[34],[58,59,60,61,62,63,64,65,66,67],"Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR Imaging","MRI","MRI Scan","NMR Imaging","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","NMRI","Nuclear Magnetic Resonance Imaging",{"type":40,"name":69,"description":70,"armGroupLabels":71,"otherNames":72},"Positron Emission Tomography","Undergo PET\u002FMRI",[34],[73,74,75,76,77,78],"Medical Imaging, Positron Emission Tomography","PET","PET Scan","Positron Emission Tomography Scan","Positron-Emission Tomography","proton magnetic resonance spectroscopic imaging",{"type":40,"name":80,"description":81,"armGroupLabels":82,"otherNames":83},"Oxygen Therapy","Receive supplemental oxygen",[34],[84],"supplemental oxygen therapy",[86,90],{"measure":87,"description":88,"timeFrame":89},"Macro-imaging level feasibility","Assessed as a factor of generating quantitative positron emission tomography (PET)\u002Fmagnetic resonance imaging (MRI) metrics (intra-tumoral FMISO tumor to blood \\[T\u002FB\\] level, hypoxic volume, dynamic susceptibility contrast enhanced \\[DSC\\], and diffusion-weighted imaging \\[DWI\\] values, and tissue oxygen maps). Images generated during the administration of oxygen will be used to generate tissue oxygen maps of the brain. Following completion of cohort enrollment, the generation of each quantitative PET\u002FMRI metric will be independently scored as a dichotomous variable; successful or non-successful. Proportional assessment will be performed to assess for project feasibility. The successful generation of PET\u002FMRI metrics in 85% of the initial cohort successfully imaged will need to be achieved for the imaging modality to be deemed feasible for this study. The estimated proportion of success rate for each metric along with the corresponding 95% binomial confidence interval will be provided.","One day of diagnostic imaging",{"measure":91,"description":92,"timeFrame":93},"MRI contrast enhancement","Measured by Response assessment in neuro-oncology criteria sum product diameter assessment. The primary outcomes for this aim are enhancement mismatch ratio and hypoxic volume. Differences in imaging metrics will be evaluated using two sample t-test. If normal assumption is not satisfied, data transformation, or 95% confidence intervals based on bootstrapping method will be used. Exploratory analysis will assess diagnostic performance of imaging metrics (mismatch ratio and hypoxic volume) to identify pseudoprogression at earlier imaging dates.","Up to 5 years",[95],{"measure":96,"description":97,"timeFrame":98},"Technical feasibility of PET\u002FMRI","The generation of co-registered imaging data sets will be independently scored as a dichotomous variable; successful or non-successful (\\\u003C 10mm versus \\[vs.\\] \\> 10mm alignment error). Proportional assessment will be performed to assess for project feasibility. The estimated proportion along with the corresponding 95% binomial confidence interval will be provided.","Baseline to the start of long-term follow-up (up to 5 years)","ALL","18 Years",null,false,{"inclusion":104,"exclusion":111,"raw_text":126},[105,106,107,108,109,110],"Adult patients (greater than 18 years of age) with a known or suspected intracranial tumor.","Able to provide informed written consent and\u002For acceptable surrogate capable of providing consent on the patient's behalf.","Legally authorized representative (LAR)-signed informed consent and assent obtained for those subjects identified as decisionally impaired","Intracranial lesion known or suspected to be neoplastic greater than 10 mL as assessed by T2\u002Ffluid attenuated inversion recovery (FLAIR) MR imaging.","Karnofsky performance score \\> 60 or Eastern Cooperative Oncology Group (ECOG) \\\u003C 3 as assessed by referring clinician.","Planning to undergo or previously received therapeutic intervention for the intracranial tumor.",[112,113,114,115,116,117,118,119,120,121,122,123,124,125],"Pregnant or breast feeding.","Contraindication to PET, MRI, FMISO, or intravenous gadolinium based contrast agents.","Claustrophobia.","Weight greater than modality maximum capacity.","Presence of metallic foreign body or implanted medical devices in body not documented as MRI safe according to the Oregon Health \\& Science University (OHSU) Department of Radiology guidelines (including but not limited to cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants).","Sickle cell disease.","Reduced renal function, as determined by glomerular filtration rate (GFR) \\\u003C 45 mL\u002Fmin\u002F1.73 m\\^2 based on a serum creatinine level obtained per OHSU Department of Radiology and Advanced Imaging Research Center (AIRC) clinical criteria.","History of allergic reactions attributed to compounds of similar chemical or biologic composition to FMISO. An allergic reaction to nitroimidazoles is highly unlikely.","Unsure of pregnancy status as assessed by Department of Radiology and AIRC guidelines.","Subjects for whom supplemental oxygen could be harmful such as people with potential for hypoventilation (end-stage COPD, OSA on CPAP\u002FBi-PAP, etc).","Subjects with a relative contraindication to supplemental oxygen administration will not be provided oxygen but may still participate in the study.","Presence of any other co-existing condition that, in the judgment of the principal investigator, might increase the risk to the subject (i.e., plans for hospice or end of life care).","Poor peripheral intravenous access evaluated by patient history.","Presence of other serious systemic illnesses, including: uncontrolled infection, other uncontrolled malignancy, uncontrolled diabetes type II, or psychiatric\u002Fsocial situations which might impact the endpoint of the study or limit compliance with study requirements.","Inclusion Criteria:\n\n* Adult patients (greater than 18 years of age) with a known or suspected intracranial tumor.\n* Able to provide informed written consent and\u002For acceptable surrogate capable of providing consent on the patient's behalf.\n* Legally authorized representative (LAR)-signed informed consent and assent obtained for those subjects identified as decisionally impaired\n* Intracranial lesion known or suspected to be neoplastic greater than 10 mL as assessed by T2\u002Ffluid attenuated inversion recovery (FLAIR) MR imaging.\n* Karnofsky performance score \\> 60 or Eastern Cooperative Oncology Group (ECOG) \\\u003C 3 as assessed by referring clinician.\n* Planning to undergo or previously received therapeutic intervention for the intracranial tumor.\n\nExclusion Criteria:\n\n* Pregnant or breast feeding.\n* Contraindication to PET, MRI, FMISO, or intravenous gadolinium based contrast agents.\n\n  * Claustrophobia.\n  * Weight greater than modality maximum capacity.\n  * Presence of metallic foreign body or implanted medical devices in body not documented as MRI safe according to the Oregon Health \\& Science University (OHSU) Department of Radiology guidelines (including but not limited to cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants).\n  * Sickle cell disease.\n  * Reduced renal function, as determined by glomerular filtration rate (GFR) \\\u003C 45 mL\u002Fmin\u002F1.73 m\\^2 based on a serum creatinine level obtained per OHSU Department of Radiology and Advanced Imaging Research Center (AIRC) clinical criteria.\n  * History of allergic reactions attributed to compounds of similar chemical or biologic composition to FMISO. An allergic reaction to nitroimidazoles is highly unlikely.\n  * Unsure of pregnancy status as assessed by Department of Radiology and AIRC guidelines.\n  * Subjects for whom supplemental oxygen could be harmful such as people with potential for hypoventilation (end-stage COPD, OSA on CPAP\u002FBi-PAP, etc).\n  * Subjects with a relative contraindication to supplemental oxygen administration will not be provided oxygen but may still participate in the study.\n* Presence of any other co-existing condition that, in the judgment of the principal investigator, might increase the risk to the subject (i.e., plans for hospice or end of life care).\n* Poor peripheral intravenous access evaluated by patient history.\n* Presence of other serious systemic illnesses, including: uncontrolled infection, other uncontrolled malignancy, uncontrolled diabetes type II, or psychiatric\u002Fsocial situations which might impact the endpoint of the study or limit compliance with study requirements.",[128,129],"ADULT","OLDER_ADULT",[131],{"facility":13,"status":8,"city":132,"state":133,"zip":134,"country":135,"contacts":136,"geoPoint":144},"Portland","Oregon","97239","United States",[137,142],{"name":138,"role":139,"phone":140,"email":141},"Ramon Barajas","CONTACT","503-494-3408","RADResearch@ohsu.edu",{"name":138,"role":143},"PRINCIPAL_INVESTIGATOR",{"lat":145,"lon":146},45.52345,-122.67621,[],[149],{"name":138,"affiliation":13,"role":143},[],[],{"nct_id":4,"conditions":153,"biomarkers":154},[19],[],{"nct_id":4,"found":15,"summary":156,"prompt_version":165},{"design":157,"status":158,"heading":6,"summary":159,"follow_up":160,"word_count":161,"commitments":162,"compensation":163,"drugs_mentioned":164},"This is an interventional study with a planned enrollment of 50 participants. It is not specified if it is randomized or blinded.","completed","This study is looking at how well a special imaging agent called ¹⁸F-fluoromisonidazole (FMISO) works with PET\u002FMRI scans to assess malignant (cancerous) brain tumors. FMISO helps doctors see the oxygen levels in a tumor, which can affect how the tumor grows and responds to treatment. PET\u002FMRI combines two types of scans to create detailed images of the brain and how it's functioning. The study aims to see if FMISO PET\u002FMRI can accurately show the oxygen levels within brain tumors. You may be eligible if you are an adult (18 years or older) with a known or suspected brain tumor. The study will measure how practical it is to get these images and if MRI contrast enhancement can help tell the difference between tumor growth and treatment effects over up to 5 years. The current status of this study is unclear.","After the diagnostic tests, participants will be followed for up to 5 years.",140,"You will receive FMISO intravenously (into a vein) and undergo PET\u002FCT or PET\u002FMRI scans multiple times. You may also receive supplemental oxygen. These diagnostic tests will be followed by a retest examination within 7 days.","Not stated in the trial record.",[31],"v2"]