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
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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.
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|Ages Eligible for Study:||18 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Men or women, age between 18 and 75 years, inclusive.
- Suspected primary lobar Glioblastoma clearly measurable on the basis of Response Assessment in Neuro-Oncology (RANO) criteria
- Newly diagnosed brain glioblastomas located in a surgically accessible brain region for resection
- The targeted tumor resection volume measures between 1 cm and 6 cm in diameter.
- Karnofsky rating 70-100.
- ASA score 1-3.
- Able to attend all study visits.
- No previous brain surgery.
- No previous radiation treatment.
- No previous systemic treatment for the tumor.
- Able and willing to give Informed Consent.
- No contraindication to MRI.
- No contraindication to brain surgery.
Contraceptive use by both male and female subjects consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Male participants: Male participants must agree that, if their partner is at risk of becoming pregnant, they will use an effective method of contraception. The participants must agree to use the contraception during the whole period of the study and for 12 weeks after the study intervention injection.
- Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: (i) is a woman of nonchildbearing potential (WONCBP) as defined in Appendix C Contraception and Barrier Guidance OR (ii) is a WOCBP and using an acceptable contraceptive method as described in Appendix C: Contraceptive and Barrier Guidance during the study intervention period (at a minimum until after the last dose of study intervention).
Brain glioblastoma presenting with the following characteristics:
- Brain edema and/or mass effect that causes midline shift of more than 15 mm
- Evidence of recent intracranial hemorrhage within the targeted tumor volume
- Calcifications in the focused ultrasound sonication path (system tools may not tailor the treatment around these calcifications)
The sonication pathway to the tumor involves either:
- more than 30% of the skull area traversed by scars, scalp disorders (e.g., eczema), or atrophy of the scalp
- Clips, shunts, or other metallic implanted objects in the skull or the brain
Cardiac disease or unstable hemodynamic status including:
- Documented myocardial infarction within six months of enrolment
- Unstable angina on medication
- Congestive heart failure
- Left ventricular ejection fraction < 50%
- Right-to-left, bidirectional, or transient right-to-left cardiac shunts
- History of a hemodynamically unstable cardiac arrhythmia
- Cardiac pacemaker
- Severe hypertension
- Anti-coagulant therapy or medications known to increase risk of hemorrhage within washout period prior to treatment
- History of a bleeding disorder, coagulopathy or with a history of spontaneous tumor hemorrhage
- Abnormal level of platelets (<100000) or INR >1.3
- Cerebral or systemic vasculopathy
- Known allergy sensitivity or contraindications to gadolinium
- Contraindications to MRI such as non-MRI-compatible implanted devices
- Subjects not fitting comfortably into the MRI scanner
- Difficulty lying supine and still for up to 4 hours in the MRI unit or claustrophobia
- Positive pregnancy test (for pre-menopausal women) (see Appendix C)
- Severely impaired renal function with estimated glomerular filtration rate <30mL/min/1.73m2 and/or on dialysis
- Respiratory: chronic pulmonary disorders (e.g., severe emphysema, COPD, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area).
- Other contraindications to 5-ALA, including chronic or acute porfiria, and hypersensibility to 5-ALA or porfirins
- Any illness or medical condition that in the investigator's opinion precludes participation in this study
- Patients unable to sign an Informed Consent
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|
|Responsible Party:||Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta|
|Other Study ID Numbers:||
|First Posted:||April 15, 2021 Key Record Dates|
|Last Update Posted:||January 18, 2023|
|Last Verified:||January 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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