Status:
COMPLETED
Sonodynamic Therapy with ExAblate System in Glioblastoma Patients
Lead Sponsor:
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 gli...
Detailed Description
Despite progress made in many cancer treatments, High-Grade Gliomas (HGG) remain an extraordinary challenge. Their aggressive and infiltrative nature, the limited efficacy and inherent risk of surgica...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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
Key Trial Info
Start Date :
February 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2024
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04845919
Start Date
February 22 2023
End Date
October 30 2024
Last Update
November 12 2024
Active Locations (1)
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1
Foundation IRCCS Carlo Besta Neurological Institute
Milan, Italy, Italy, 20133