Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05733312
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2023-01-28
Brief Title:
Extracellular Impact of Ultrasound-induced Blood-brain Barrier Disruption
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Intraoperative Evaluation of Focused Ultrasound-induced Blood-brain Barrier Disruption
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
This protocol performs FUS immediately prior to clinically indicated brain tumor resection Accordingly any drugs administered in the context of routine clinical care such as Ancef levetiracetam and mannitol and imaging agents gadolinium and iopamidol clinically available for pre-operative imaging via MRI or CT respectively will be quantified in plasma as well as the interstitial fluid of brain tumor and adjacent brain tissue within and outside the volume of FUS treatment Patients with large 3cm gliomas and no known contraindications to contrast agents or surgery will be recruited to undergo pre-operative Exablate 4000 Type-2 MR-guided FUS prior to intraoperative high molecular weight microdialysis and standard-of-care glioma resection Intra-operative CT or O-arm will be obtained with contrast to document the location of catheters relative to tumor and region of blood brain barrier disruption following FUS prior to tumor resection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-03111 | REGISTRY | CTRP Clinical Trial Reporting Program | None |