Extracellular Impact of Ultrasound-induced Blood-brain Barrier Disruption
ConditionBrain Tumor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
This study seeks to determine the impact of focused ultrasound (FUS) on the composition of the tumor extracellular microenvironment. Researchers will evaluate regions that are very abnormal, as well as regions that have less evidence of disease. A sub-portion of each of these areas will be targeted by focused ultrasound. Microdialysis catheters will then be placd into each region that has and has not been exposed to FUS (total of 4 catheters) to determine how FUS impacts the the brain and tumor extracellular metabolome, including concentration of routine drugs systemically administered prior to, and during surgery. Researchers hope that this information will help reveal the relative contribution of blood-derived compounds to the tumor microenvironment. If successful, microdialysis could be leveraged in the future to simultaneously evaluate pharmacokinetic and pharmacodynamic impacts of future candidate therapies, including those delivered with the aid of FUS.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical and radiographic evidence suggesting a diagnosis of a diffuse glioma, or a prior diagnosis of a diffuse glioma, which is large enough (≥3cm) for half of the tumor to be targeted by FUS, but small enough for the standard-of-care resection to incorporate some regions of relatively normal brain adjacent to tumor.
Planned neurosurgical resection of this suspected or previously diagnosed brain tumor as part of routine clinical care.
Provide written informed consent for the current study and the Neuro-Oncology biorepository for archiving of microdialysate and blood samples collected on this protocol.
ECOG performance status (PS) 0, 1, or 2. Willing to undergo neurosurgical resection at Mayo Clinic (Rochester, MN).
Disqualifiers
Patients who are not appropriate surgical candidates due to current or past medical history or uncontrolled concurrent illness which limits safety of or compliance to study proceedings.
Vulnerable populations: pregnant or nursing women, prisoners, mentally handicapped.
Contraindication to Definity®.
Cardiac disease or coagulative disease (such as cerebral or systemic vasculopathy, abnormal platelets, documented MI within 6 months of enrollment, pacemaker, hemodynamically unstable cardiac arrhythmia, unstable congestive heart failure, or left ventricular ejection fraction <50%), that would preclude the use of Definity ®, FUS-induced BBB disruption, or surgical resection.
Trial design
Design model
Single group
Treatments tested in this trial
InSightec's ExAblate Neuro Model 4000 Type 2.0 (220 KHz) system
DeviceFocused ultrasound which targets energy to a specific area in the brain based on imaging and disrupts the blood brain barrier which keeps certain drugs and other molecules out of the brain.
Treatment groups
6 Participants
are divided into 1 treatment groupGroup A: Focused UltrasoundExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse events
Number of adverse deemed related to FUS and/or intraoperative microdialysis after the integration of FUS and intraoperative microdialysis into the neurosurgical workflow for tumor resection
Time frame
3 months post-surgery2
Number of microdialysate aliquots
Number of microdialysate aliquots collected containing \>10 μL of volume
Time frame
3 months post-surgerySponsors and contacts
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Source ClinicalTrials.gov