Sonodynamic Therapy in Patients With Recurrent GBM
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShayan Moosa, MD
About this trial
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. Focused ultrasound (FUS) can be used to non-invasively destroy tumor tissue while preserving normal tissue. When FUS is combined with 5-ALA, this combinatorial approach is called sonodynamic therapy (SDT), and this investigational therapy is being tested for its ability to cause damage to GBM cells. SDT will take place prior to surgery for recurrent GBM.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- 5-ALA and Low-Intensity Focused Ultrasound (SDT)
Treatment groups
11 Participants
are divided into 1 treatment groupSponsors and collaborators
Shayan Moosa, MD
Lead sponsor
University of Virginia
Sponsor institution
Source ClinicalTrials.gov