[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598821":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":103,"centralContacts":107,"locations":113,"responsibleParty":132,"collaborators":134,"id":138,"slug":139,"hasResults":140,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":59,"eligibilityCriteria":144,"healthyVolunteers":140,"sex":145,"minAge":146,"maxAge":59,"enrollmentInfo":147,"targetDuration":59,"studyType":150,"phases":151,"briefSummary":153,"conditions":154,"keywords":59,"overallStatus":116,"whyStopped":59,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment (SONALA-001, MRgFUS)","EXPERIMENTAL","Patients receive SONALA-001 IV over 15 minutes or 5-ALA HCL PO and undergo transcranial MRgFUS 3-8 hours after infusion on day 1 of each cycle. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo a CT of the brain prior to treatment and blood sample collection and MRI throughout the study.",[13,14,15,16,17,18,19],"Drug: Aminolevulinic Acid Intravenous Formulation SONALA-001","Procedure: Biospecimen Collection","Procedure: Computed Tomography","Other: Electronic Health Record Review","Procedure: Magnetic Resonance Imaging","Procedure: MRI-Guided Focused Ultrasound Ablation","Drug: Oral Aminolevulinic Acid Hydrochloride",[21,31,40,55,60,80,91],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Aminolevulinic Acid Intravenous Formulation SONALA-001","Given IV",[9],[27,28,29,30],"ALA Intravenous Formulation SONALA-001","SONALA 001","SONALA-001","SONALA001",{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"PROCEDURE","Biospecimen Collection","Undergo blood sample collection",[9],[37,38,39],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",{"type":32,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Computed Tomography","Undergo CT",[9],[45,46,47,48,49,50,51,52,53,54],"CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan","tomography",{"type":6,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"Electronic Health Record Review","Ancillary studies",[9],null,{"type":32,"name":61,"description":62,"armGroupLabels":63,"otherNames":64},"Magnetic Resonance Imaging","Undergo MRI",[9],[65,66,67,68,69,70,71,72,73,74,75,76,77,78,79],"Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging","sMRI","Structural MRI",{"type":32,"name":81,"description":82,"armGroupLabels":83,"otherNames":84},"MRI-Guided Focused Ultrasound Ablation","Undergo transcranial MRgFUS",[9],[85,86,87,88,89,90],"Magnetic Resonance Imaging-guided High-Intensity Focused Ultrasound","Magnetic Resonance-guided Focused Ultrasound","MR-HIFU","MRgFUS","MRI Guided Focused Ultrasound Surgery","MRI-HIFU",{"type":22,"name":92,"description":93,"armGroupLabels":94,"otherNames":95},"Oral Aminolevulinic Acid Hydrochloride","Given PO",[9],[96,97,98,99,100,101,102],"5-ALA fluorescence","5-Aminolevulinic Acid Hydrochloride","5-Aminolevulinic Acid Hydrochloride, Oral","Gleolan","Gliolan","Oral 5-ALA","Oral ALA HCl",[104],{"name":105,"affiliation":5,"role":106},"Terence C. Burns, MD, PhD","PRINCIPAL_INVESTIGATOR",[108],{"name":109,"role":110,"phone":111,"phoneExt":59,"email":112},"Clinical Trials Referral Office","CONTACT","855-776-0015","mayocliniccancerstudies@mayo.edu",[114],{"facility":115,"status":116,"city":117,"state":118,"zip":119,"country":120,"countryCode":121,"cosmosGeoPoint":122,"geoPoint":127,"contacts":128},"Mayo Clinic in Rochester","RECRUITING","Rochester","Minnesota","55905","United States","US",{"type":123,"coordinates":124},"Point",[125,126],-92.4699,44.02163,{"lat":126,"lon":125},[129,130],{"name":109,"role":110,"phone":59,"phoneExt":59,"email":112},{"name":131,"role":106,"phone":59,"phoneExt":59,"email":59},"Terry Burns, MD, PhD",{"type":133,"investigatorFullName":59,"investigatorTitle":59,"investigatorAffiliation":59,"oldNameTitle":59,"oldOrganization":59},"SPONSOR",[135],{"name":136,"class":137},"National Cancer Institute (NCI)","NIH","100598821","early-phase-1-sonodynamic-therapy-with-sonala-001-or-5-ala-hcl-and-magnetic-resonance-guided-focused-ultrasound-for-the-treatment-of-progressive-or-recurrent-glioblastoma-100598821",false,"NCT07076472","Sonodynamic Therapy With SONALA-001 or 5-ALA HCL and Magnetic Resonance Guided Focused Ultrasound for the Treatment of Progressive or Recurrent Glioblastoma","MC240704 Pilot Dose Escalation and Expansion Study of Sonodynamic Therapy With Aminolevulinic Acid Hydrochloride (5-ALA HCl Or SONALA-001) in Combination With Exablate 4000 Type 2.0 MR-Guided Focused Ultrasound (MRgFUS) in Patients With Progressive or Recurrent Glioblastoma Multiforme (RGBM)","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of recurrent or progressive glioblastoma (as defined in 2021 World Health Organization \\[WHO\\] Classification of Tumors of the Central Nervous System; Louis, Perry, et al. 2021) for which resection is not indicated as assessed by the study physician\n* Radiographic evidence of disease which may be measurable or non-measurable\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2\n* Previous treatment with radiotherapy (RT)\n* Have a life expectancy of ≥ 12 weeks\n* Hemoglobin ≥ 9.0 g\u002FdL (obtained ≤ 15 days prior to registration)\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 (obtained ≤ 15 days prior to registration)\n* Platelet count ≥ 100,000\u002Fmm\\^3 (obtained ≤ 15 days prior to registration)\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 15 days prior to registration)\n* Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 15 days prior to registration)\n* Albumin ≥ 3 g\u002FdL (obtained ≤ 15 days prior to registration)\n* Potassium ≥ lower limit of normal (LLN) (obtained ≤ 15 days prior to registration)\n* Serum total calcium ≥ LLN (obtained ≤ 15 days prior to registration)\n* Creatinine ≤ 1.5 x ULN OR calculated creatinine clearance ≥ 60 mL\u002Fmin using the Cockcroft-Gault formula (obtained ≤ 15 days prior to registration)\n* Negative pregnancy test done ≤ 8 days prior to registration, for persons of childbearing potential only\n* Provide written informed consent\n* Willing to participate in the neuro-oncology biorepository \\[Institutional Review Board (IRB) 12-003458, principal investigator (PI): Jann Sarkaria, MD, PhD\\] for collecting and archiving biospecimens samples on neuro-oncology patients\n* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n\nExclusion Criteria:\n\n* Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception\n* Recurrence ≤ 4 weeks after the completion of RT, defined from the imaging assessment immediately after completion of RT\n* Three or more prior systemic treatments for recurrent or progressing disease\n* Diagnosis of porphyria, or hypersensitivity to porphyrins\n* Failure to recover to grade 1 or baseline from any adverse events (AEs) (Common Terminology Criteria for Adverse Events \\[CTCAE\\] version \\[v\\] 5.0) related to prior anticancer therapy\n\n  * EXCEPTIONS: Alopecia, lymphopenia, peripheral neuropathy, and ototoxicity ≤ grade 3)\n* Known history of the following conditions:\n\n  * Allergy to gadolinium contrast agents\n  * Patients known to be HIV positive and currently receiving antiretroviral therapy\n\n    * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial\n* Inability to undergo MRI scans\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Patients with platelet count \\\u003C 100\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens","ALL","18 Years",{"count":148,"type":149},8,"ESTIMATED","INTERVENTIONAL",[152],"EARLY_PHASE1","This early phase I trial tests the safety, best dose, and effectiveness of SONALA-001 or 5-ALA HCL in combination with magnetic resonance imaging-guided focused ultrasound (MRgFUS), also called sonodynamic therapy, in treating patients with glioblastoma that is growing, spreading, or getting worse (progressive) or that has come back after a period of improvement (recurrent). Sonodynamic therapy is a non-invasive combination therapy that uses low-intensity ultrasound, such as MRgFUS, to activate a drug, such as SONALA-001 or 5-ALA HCL, to kill tumor cells. SONALA-001 or 5-ALA HCL binds to the tumor and may help the sonodynamic therapy target the tumor. MRgFUS is an image-guided, non-invasive technique that uses high energy ultrasound from the Exablate 4000 Type 2.0 device to kill tumors without damaging surrounding healthy tissue. Giving sonodynamic therapy using SONALA-001 or 5-ALA HCL with MRgFUS may be safe, tolerable, and\u002For effective in treating patients with progressive or recurrent glioblastoma.",[155,156],"Progressive Glioblastoma","Recurrent Glioblastoma","2026-02-19",{"date":159,"type":160},"2026-02-23","ACTUAL",{"date":162,"type":160},"2025-08-14",{"date":164,"type":149},"2026-12-31",{"name":5,"class":6},1]