Health Trials

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 group

Locations

1
University of Virginia22903, CharlottesvilleVirginia, United States

Sponsors and collaborators

Shayan Moosa, MD

Lead sponsor

University of Virginia

Sponsor institution

Source ClinicalTrials.gov