Clinical Trials Directory

Trials / Terminated

TerminatedNCT02372409

Using MRI-Guided Laser Heat Ablation to Induce Disruption of the Peritumoral Blood Brain Barrier to Enhance Delivery and Efficacy of Treatment of Pediatric Brain Tumors

A Pilot Study of Using MRI-Guided Laser Heat Ablation to Induce Disruption of the Peritumoral Blood Brain Barrier to Enhance Delivery and Efficacy of Treatment of Pediatric Brain Tumors

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
6 (actual)
Sponsor
Washington University School of Medicine · Academic / Other
Sex
All
Age
3 Years – 21 Years
Healthy volunteers
Not accepted

Summary

By employing a combination of advanced MRI techniques and correlative serum biomarkers of blood brain barrier (BBB) disruption, the investigators plan to develop a powerful, first of its kind clinical algorithm in pediatrics whereby the investigators can measure and identify the window of maximal BBB disruption post MLA to 1) allow for an alternative to surgery in incompletely resected tumors, 2) allow for optimal chemotherapeutic dosing to achieve the greatest benefits and the least systemic side effects and 3) distinguish subsequent tumor progression from long-term MLA treatment effects. Preliminary data in adult imaging studies have shown that the BBB disruption lasts for several weeks following treatment before returning to a low baseline. This pilot therapeutic study will provide preliminary validation in pediatric patients.

Conditions

Interventions

TypeNameDescription
DEVICEMRI-guided laser ablation
DRUGDoxorubicin
DRUGEtoposide
DEVICEDynamic contrast-enhanced (DCE) MRI
DEVICEDynamic susceptibility contrast (DSC) MRI

Timeline

Start date
2015-08-14
Primary completion
2023-03-23
Completion
2023-03-23
First posted
2015-02-26
Last updated
2024-11-01
Results posted
2024-08-09

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT02372409. Inclusion in this directory is not an endorsement.