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Procedure

MRI-Guided Laser Ablation + Chemotherapy for Brain Cancer

Phase 2

Recruiting

Led By Joshua Rubin, M.D., Ph.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ARM A: Presumed pediatric gliomas (grades I-IV) on MRI that are determined to be candidates for MLA by the treating neurosurgeon, Age 3 to ≤ 21, Karnofsky/Lansky performance status ≥ 60%

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial will use MRI and blood tests to develop a way to measure and identify when the blood brain barrier is most disrupted after treatment for brain tumors, in order to improve treatment.

Who is the study for?

This trial is for children and young adults aged 3 to 21 with certain types of brain tumors, including various grades of gliomas. Participants must have a performance status indicating they can carry out daily activities (≥60%), adequate heart, liver, and bone marrow function, and not exceed prior anthracycline therapy limits. Pregnant individuals or those unable to undergo MRI are excluded.Check my eligibility

What is being tested?

The study tests the timing of maximal blood-brain barrier disruption using MRI-guided laser ablation followed by chemotherapy in pediatric patients. The goal is to optimize treatment delivery while minimizing systemic side effects and distinguishing between tumor progression and treatment effects.See study design

What are the potential side effects?

Potential side effects include typical reactions to doxorubicin such as hair loss, nausea, vomiting, mouth sores; etoposide may cause low blood counts leading to infection risk; MRI-guided laser ablation could result in localized pain or swelling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 3 and 21 years old with a brain tumor suitable for surgery and can do most activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Arm A only: Overall survival (OS)

Arm A only: Progression-free survival (PFS)

Arm B only: Progression-free survival (PFS)

+1 more

Secondary outcome measures

Correlation of MR imaging with peritumoral BBB disruption

Predictive value of the peritumoral permeability score for patient outcome as measured by PFS

Serum biomarkers of peritumoral BBB disruption

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B (MRI-guided laser ablation, doxorubicin, etoposide)Experimental Treatment5 Interventions

MLA is a minimally invasive laser surgery currently FDA approved for cytoreductive treatment of brain tumors, both primary and metastatic. MLA employs a small incision in the scalp and skull, through which a thin laser probe is inserted and guided by MR imaging to the core of a tumor mass where it delivers hyperthermic ablation from the core to the rim. Within 7 days of MLA (range 2-14 days) doxorubicin will be given intravenously on an outpatient basis weekly for 6 weeks at a dose of 25 mg/m^2 over 5-30 minutes Following the completion of doxorubin, etoposide 50 mg/m^2/day will be given orally for 21 days of each 28-day cycle (treatment can continue up to 24 cycles) Participants will undergo DCE and DSC-MRI imaging at the following time points: no more than 3 weeks prior to MLA (OPTIONAL) within approximately 4 days after MLA 2-4 weeks after MLA every 8 weeks (+/- 7 days) until 2 years have elapsed or disease progression, whichever comes first

Group II: Arm A (MRI-guided laser ablation)Experimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Doxorubicin

2012

Completed Phase 3

~7940

Etoposide

2010

Completed Phase 3

~2440

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,935 Previous Clinical Trials

2,299,795 Total Patients Enrolled

Joshua Rubin, M.D., Ph.D.Principal InvestigatorWashington University School of Medicine

1 Previous Clinical Trials

Margaret Shatara, M.D.Principal InvestigatorWashington University School of Medicine

Media Library

MRI-guided laser ablation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT02372409 — Phase 2

Brain Tumor Research Study Groups: Arm B (MRI-guided laser ablation, doxorubicin, etoposide), Arm A (MRI-guided laser ablation)

Brain Tumor Clinical Trial 2023: MRI-guided laser ablation Highlights & Side Effects. Trial Name: NCT02372409 — Phase 2

MRI-guided laser ablation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02372409 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research represent a pioneering effort?

"Developed by Alfacell and tested in their inaugural clinical trial back in 1997 with 300 participants, Dynamic Susceptibility Contrast (DSC) MRI has since been approved for Phase 3 drug use. Currently, 72 countries across 2214 cities are running 589 active studies which investigate the efficacy of this medication."

Answered by AI

Is the current protocol for this clinical trial limited to individuals under 55 years old?

"The age range accepted by this medical trial is 3 to 21 years old. According to public records, there are 325 other clinical trials that cater specifically for minors while 1033 studies prioritize elderly patients."

Answered by AI

What potential risks have been associated with Dynamic susceptibility contrast (DSC) MRI?

"The safety of Dynamic Susceptibility Contrast (DSC) MRI is rated a 2 on the scale from 1 to 3, as there are some studies which demonstrate its safety but none that affirm its efficacy."

Answered by AI

In what situations is Dynamic susceptibility contrast (DSC) MRI typically utilized?

"DSC MRI is a popular treatment for Kaposi's Sarcoma related to AIDS, and has also been found effective in managing Merkel Cell Cancer, neoplasm metastasis, and advanced thymoma."

Answered by AI

Could you outline the past experiments utilizing Dynamic susceptibility contrast (DSC) MRI?

"Currently, there are 589 live clinical trials investigating Dynamic Susceptibility Contrast (DSC) MRI with 178 of them in the third phase. Seattle, Washington is hosting several such studies; however, this technology is employed across a total of 3440 locations globally."

Answered by AI

Are there any specific demographics that are favored for enrollment in this study?

"This particular medical trial is seeking 12 participants with pilocytic astrocytoma ranging in age from 3 to 21."

Answered by AI

Are there any openings available for this research venture?

"Affirmative. According to the information uploaded on clinicaltrials.gov, this research study is still seeking participants since it was initially posted in August 2015 and last updated June 22nd 2022. In total, 12 patients must be sourced from a single location."

Answered by AI

What is the current participant count for this medical research?

"Affirmative. According to clinicaltrials.gov, this medical experiment is actively sourcing for volunteers; it was created on August 14th 2015 and was updated as recently June 22nd 2022. It needs a cohort of 12 participants from just one trial site."

Answered by AI

Recent research and studies

Journal of NeurotraumaJournal

Validation of Serum Markers for Blood-brain Barrier Disruption in Traumatic Brain Injury

Blyth, Brian J., Arash Farhavar, Christopher Gee, Brendan Hawthorn, Hua He, Akshata Nayak, Veit Stöcklein, and Jeffrey J. Bazarian. 2009. “Validation of Serum Markers for Blood-brain Barrier Disruption in Traumatic Brain Injury”. Journal of Neurotrauma. Mary Ann Liebert Inc. doi:10.1089/neu.2008.0738.

NeurosurgeryJournal

Cancer Immunoediting in Malignant Glioma

Dunn, Gavin P., Peter E. Fecci, and William T. Curry. 2012. “Cancer Immunoediting in Malignant Glioma”. Neurosurgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1227/neu.0b013e31824f840d.

Methods in Molecular BiologyJournal

Measuring the Integrity of the Human Blood–brain Barrier Using Magnetic Resonance Imaging

Kassner, Andrea, and Rebecca Thornhill. 2010. “Measuring the Integrity of the Human Blood–brain Barrier Using Magnetic Resonance Imaging”. Methods in Molecular Biology. Humana Press. doi:10.1007/978-1-60761-938-3_10.

Operative NeurosurgeryJournal