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New treatment option for Recurrent Glioblastoma
Official title Sonodynamic Therapy in Patients With Recurrent GBM
ClinicalTrials.gov ID: NCT06039709
What this study is testing
What is 5-ALA and Low-Intensity Focused Ultrasound (SDT)?
5-ALA and Low-Intensity Focused Ultrasound (SDT) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for recurrent glioblastoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Patients diagnosed with glioblastoma (GBM) are faced with limited treatment options. This pilot study will evaluate the safety and feasibility of combining an investigational drug called 5-ALA with neuronavigation-guided low-intensity focused ultrasound (LIFU) for patients who have recurrent GBM.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Disease status and Disease Parameters:
- Suspected recurrent glioblastoma that is clearly measurable based on the modified Response Assessment in Neuro-Oncology (RANO) criteria
- The tumor lesion needs to comprise at least 1 contrast-enhancing lesion with a volume of ≥ 2 cm3 and ≤ 20 cm3 of targeted treatment area
- Tumor tissue to be treated is in a surgically accessible brain region for resection
- The brain tumor to be treated must be in the treatment envelope of the NaviFUS system (30 mm to 90 mm from the inner skull table)
You likely can't join if
- Known sensitivity or allergy to 5-ALA
- Simultaneous use of other potentially phototoxic substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts)
- Diagnosis of porphyria
- Hypersensitivity against porphyrins
- Pregnancy
- Significant cardiac disease or coagulopathy
See the full eligibility criteria
- Disease status and Disease Parameters:
- Suspected recurrent glioblastoma that is clearly measurable based on the modified Response Assessment in Neuro-Oncology (RANO) criteria
- The tumor lesion needs to comprise at least 1 contrast-enhancing lesion with a volume of ≥ 2 cm3 and ≤ 20 cm3 of targeted treatment area
- Tumor tissue to be treated is in a surgically accessible brain region for resection
- The brain tumor to be treated must be in the treatment envelope of the NaviFUS system (30 mm to 90 mm from the inner skull table)
- Recurrence will be assessed by imaging and confirmed by consensus at tumor board
- Men or women between the ages of 18-80 years of age at the time of consent
- No contraindication to repeat brain surgery
- Karnofsky Performance Score of 70-100
- Able to undergo an MRI with contrast
- Able to swallow oral medications
- Willingness and ability to comply with scheduled visits, treatment plans, lifestyle considerations, laboratory tests, and other procedures.
- Ability to understand and the willingness to sign a written informed consent document (personally or by the legally authorized representative, if applicable).
- Participants who received prior chemotherapy, radiation therapy, immunotherapy, and/or another investigational therapy must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] Grade ≤1 or baseline)...
- Has adequate bone marrow and organ function as defined by the following laboratory values (as assessed by the local laboratory for eligibility): Hematological
- Absolute neutrophil count (ANC) ≥1000/mm3
- Platelets ≥ 100,000/mm3
- Hemoglobin ≥ 11 g/dL for women and ≥ 12 g/dL for men Participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator.
- INR ≤ 1.4 Renal \& Hepatic
- Creatinine clearance CrCl ≥ 60 mL/min/1.73 m2 as estimated by the Cockcroft-Gault (C-G) equation. If estimated CrCl is abnormal, accurate measurement should be obtained by 24- hour CrCl.
- Bilirubin ≤ 1.5 x ULN (except in patients with Gilbert's disease, where bilirubin to 2.0x ULN is allowed).
- AST and ALT ≤ 3 x ULN
- Alkaline phosphatase ≤ 3 x ULN
- Estimated glomerular filtration rate ≥30mL/min/1.73m2
- Known sensitivity or allergy to 5-ALA
- Simultaneous use of other potentially phototoxic substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts)
- Diagnosis of porphyria
- Hypersensitivity against porphyrins
- Pregnancy
- Significant cardiac disease or coagulopathy
- Herniation / intractable seizure / other clinical indications requiring urgent resection
- Known active systemic bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus...
- Have had a recent (≤3 months prior to registration) transient ischemic attack or stroke
- Significant vascular disease (e.g. aortic aneurysm)
- Evidence of bleeding diathesis or coagulopathy
- Need for systemic anticoagulation which cannot be held for 7 days prior to SDT
- Unstable angina and/or congestive heart failure (NYH Class III or Class IV; see section 13.2) within 6 months prior to registration
- Severe hypertension (systolic ≥ 180 mm Hg; diastolic ≥ 120 mm Hg) despite anti-hypertensive medications
- Transmural myocardial infarction within 6 months prior to registration
- Serious and inadequately controlled cardiac arrhythmia
- Acute exacerbation of chronic obstructive pulmonary disease
- Has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study
- Treatment with another investigational drug or investigational procedure within 30 days prior to registration or within 5 half-lives of the investigational product, whichever is longer
- Brain edema and/or mass effect that causes midline shift of more than 15 mm
- Evidence of recent (within 30 days prior to registration) intracranial hemorrhage
- Calcifications or metallic implanted objects in the focused ultrasound sonication path
- Scalp atrophy or scars at the expected location of transducer
- Cerebral or systemic vasculopathy
- Need for or currently on dialysis
- Respiratory: chronic pulmonary disorders (e.g., severe emphysema, COPD, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area).
- Receipt of radiotherapy ≤21 days prior to registration
- Receipt of chemotherapy ≤ 21 days prior to registration
- Prior treatment with sonodynamic therapy
- Concurrent use of Optune device
- Concurrent use of supplements or medications with substantial antioxidant effects (including sulfhydryl-containing medications such as captopril or supplements such as N-acetylcysteine, or high doses of vitamins with...
- Known sensitivity to gadolinium
The study team makes the final eligibility decision.
Where it's taking place
- Charlottesville, Virginia, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.