Sonodynamic Therapy With ExAblate System in Glioblastoma Patients (Sonic ALA)
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|ClinicalTrials.gov Identifier: NCT04845919|
Recruitment Status : Not yet recruiting
First Posted : April 15, 2021
Last Update Posted : January 18, 2023
The goal of this prospective, non-randomized, single-arm study is to evaluate the safety and feasibility of sonodynamic therapy with 5-aminolevulinic acid in patients with newly diagnosed cerebral glioblastomas using the ExAblate Model 4000 Type-2 "Neuro-System".
Patients will be consented, screened, and will undergo study SDT treatment with 5-ALA using the ExAblate Model 4000 Type-2 "Neuro-System". After SDT treatment, patients will perform a strict neuro-radiological follow-up (minimum of 2 MRI) and undergo tumor resection 15-21 days after SDT, according to the clinical and radiological status.
The main goal of the present study is to investigate the safety and feasibility of SDT in patients affected by GBMs attained with low-frequency FUS.
Safety will be evaluated by patient examination and MRI images during the treatment, and by follow-up MRI and clinical and neurological visits.
To evaluate feasibility, the extent of the sonicated area will be calculated at the end of the procedure in order to evaluate the targeted area.
Secondary objective of the trial is to assess the efficacy of the SDT procedure in terms of tumor regression and/or cell apoptosis and necrosis.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme||Drug: 5-Aminolevulinic Acid||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study to Evaluate the Safety and Feasibility of Sonodynamic Therapy Using the ExAblate MRI-Guided Focused Ultrasound in the Treatment of Cerebral Glioblastomas.|
|Estimated Study Start Date :||February 2023|
|Estimated Primary Completion Date :||November 2023|
|Estimated Study Completion Date :||November 2023|
|Experimental: 5-ALA mediated sonodynamic therapy||
Drug: 5-Aminolevulinic Acid
SDT treatment with 5-ALA using the ExAblate Model 4000 Type-2 "Neuro-System".
- Presence of hemorrhage, edema or other damages [ Time Frame: 10 days after the procedure ]MR images will be acquired before the procedure and will also be used to guide the FUS treatment; new MRI scans will be acquired at immediately after and at 24 hours, 5 days and 10 days after the procedure and will be analyzed to identify any focal alteration within the treatment's radius compatible with hemorrhages, necrosis, oedema, inflammation or other damages
- Rate of neurological deficits [ Time Frame: 10 days after the procedure ]Patients will be clinically evaluated to identify any change in their clinical picture or new onset of neurological symptoms/deficits,
- Radiological response to treatment [ Time Frame: 10 days after the procedure ]Tumor volume at baseline will be assessed for each patient as gadolinium-enhancing parenchymal regions before any follow-up scan. Post-treatment tumor volumes will be assessed at all follow-up MRI scans, and radiological response to sonodynamic therapy -i.e. the change in pathological volume after the treatment- will be determined by confronting baseline and follow-up scans by the RANO Criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04845919
|Contact: Francesco Prada, MD||+39022394 ext firstname.lastname@example.org|
|Contact: Renato Mantegazza, MD||+39022394 ext email@example.com|