Health TrialsbyHealthPanel

Sonodynamic Therapy in Patients With Recurrent GBM

ConditionsRecurrent GlioblastomaGlioblastoma MultiformeGBM
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • 5-ALA and Low-Intensity Focused Ultrasound (SDT)

    Combination product

    5-ALA (20mg/kg orally) given \~6 hours prior to LIFU. Focused ultrasound will target a maximum of 50% of the tumor.

Treatment groups

11 Participants
are divided into 1 treatment group
Group A: Sonodynamic Therapy (5-ALA + LIFU)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of adverse events

Per NCI Common Terminology Criteria for Adverse Events v5.0

Time frame
From informed consent through 30 days after study intervention is complete
2

Severity of adverse events

Per NCI Common Terminology Criteria for Adverse Events v5.0

Time frame
From informed consent through 30 days after study intervention is complete
3

Incidence of intracranial hemorrhage and/or worsening of edema

On post-SDT MRIs

Time frame
From day after SDT (day 1) up to the time of surgery (day 7-day 21)
4

Extent of targeted tumor area receiving FUS

Use of NaviFUS system to target a maximum of 50% of the tumor volume of one contiguous lesion

Time frame
Day 0

Secondary outcomes

1

Response of target tissue following SDT on imaging

Via MRI w/ use of modified Response Assessment in Neuro-Oncology (RANO) criteria

Time frame
From day after SDT (day 1) up to 100 days after intervention is completed
2

Histologic tumor devitalization

Evaluating cell fate and cell death via histologic samples after GBM resection

Time frame
Day 7-Day 21

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shayan Moosa, MD

Lead sponsor

University of Virginia

Sponsor institution

Source ClinicalTrials.gov
Apply now