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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

NCT02372409 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-11-01

Study results available
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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

  • Glioma
  • Pilocytic Astrocytoma
  • Anaplastic Astrocytoma
  • Glioblastoma
  • Mixed Oligoastrocytoma
  • Mixed Glioma
  • Oligodendroglioma
  • Optic Glioma
  • Astrocytoma

Interventions

DEVICE

MRI-guided laser ablation

DRUG

Doxorubicin

DRUG

Etoposide

DEVICE

Dynamic contrast-enhanced (DCE) MRI

DEVICE

Dynamic susceptibility contrast (DSC) MRI

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Andrew Cluster, M.D. · Washington University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-14
Primary Completion
2023-03-23
Completion
2023-03-23
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02372409 on ClinicalTrials.gov