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
TerminatedPhase 2Results postedLast updated 1 November 2024
What this trial tests
Phase 2 trial testing MRI-guided laser ablation in Glioma in 6 participants. Terminated before completion.
Adults 3 to 21, any sex, with Glioma or Pilocytic Astrocytoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Arm A Only: Number of Participants With Progression-free Survival (PFS)Primary· Up to 5 years from date of registration (median length of follow-up, full range 196 days-1801 days)
PFS is followed from start of treatment to time of progression or death, whichever occurs first.
Group
Value
95% CI
Arm A (MRI-guided Laser Ablation)
4
Arm A Only: Overall Survival (OS) as Measured by Number of Participants Alive at 5 YearsPrimary· Up to 5 years from date of registration (median length of follow-up, full range 196 days-1801 days)
Group
Value
95% CI
Arm A (MRI-guided Laser Ablation)
5
Arm B Only: Number of Participants With Progression-free Survival (PFS)Primary· At 6 months
PFS is followed from start of treatment to time of progression or death, whichever occurs first.
Group
Value
95% CI
Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide)
0
Change in Quality of Life as Measured by Karnofsky or Lansky Performance StatusSecondary· At 1 year post-MLA
Score ranges from 100% to 10%. A higher score indicates that the patient has a more normal quality of life.
Baseline
Group
Value
95% CI
Patient 1: Arm A (MRI-guided Laser Ablation)
90
Patient 2: Arm A (MRI-guided Laser Ablation)
100
Patient 3: Arm A (MRI-guided Laser Ablation)
80
Patient 4: Arm A (MRI-guided Laser Ablation)
100
Patient 5: Arm A (MRI-guided Laser Ablation)
100
1 year post-MLA
Group
Value
95% CI
Patient 1: Arm A (MRI-guided Laser Ablation)
90
Patient 2: Arm A (MRI-guided Laser Ablation)
100
Patient 3: Arm A (MRI-guided Laser Ablation)
80
Patient 4: Arm A (MRI-guided Laser Ablation)
100
Patient 5: Arm A (MRI-guided Laser Ablation)
100
Serum Biomarkers of Peritumoral Blood Brain Barrier (BBB) Disruption as Measured by Change in Neuron-specific Enolase (NSE)Secondary· Up to 48 weeks post MRI-guided laser heat ablation (Arm A) or up to 2 years post MRI-guided laser heat ablation (Arm B)
* Arm A patients had blood drawn at the following time points: baseline, 3 days post-MLA, 2-4 weeks post-MLA, and every 12 weeks thereafter for 12 months post-MLA
* Arm B patients had blood drawn at the following time points: baseline, 3 days post-MLA, week 1, week 2, week 3, week 4, week 5, week 6, and every 8 weeks for the first 2 years or until disease progression, whichever occurs first.
* Neuron specific enolase is an enzyme involved in glycolysis, which is localized in neurons and axonal processes. Potentially, it escapes into the blood and CSF at the time of neural injury. Elevated seru
Baseline
Group
Value
95% CI
Patient 1: Arm A (MRI-guided Laser Ablation)
29.0219
Patient 4: Arm A (MRI-guided Laser Ablation)
58.3406
Patient 3: Arm A (MRI-guided Laser Ablation)
3.1823
Patient 5: Arm A (MRI-guided Laser Ablation)
13.1819
Patient 6: Arm A (MRI-guided Laser Ablation)
7.5534
Patient 1: Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide)
11.5114
Day 3
Group
Value
95% CI
Patient 1: Arm A (MRI-guided Laser Ablation)
47.2666
Patient 4: Arm A (MRI-guided Laser Ablation)
26.7537
Patient 3: Arm A (MRI-guided Laser Ablation)
6.0443
Patient 5: Arm A (MRI-guided Laser Ablation)
33.8034
Patient 6: Arm A (MRI-guided Laser Ablation)
17.4680
Patient 1: Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide)
18.5711
1 week
Group
Value
95% CI
Patient 1: Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide)
11.5909
2 week
Group
Value
95% CI
Patient 1: Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide)
8.6069
2-4 weeks
Group
Value
95% CI
Patient 1: Arm A (MRI-guided Laser Ablation)
12.0186
Patient 4: Arm A (MRI-guided Laser Ablation)
53.2519
Patient 3: Arm A (MRI-guided Laser Ablation)
5.4452
Patient 5: Arm A (MRI-guided Laser Ablation)
11.4998
Patient 6: Arm A (MRI-guided Laser Ablation)
9.3916
4 week
Group
Value
95% CI
Patient 1: Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide)
5.7440
12 weeks
Group
Value
95% CI
Patient 1: Arm A (MRI-guided Laser Ablation)
105.7828
Patient 4: Arm A (MRI-guided Laser Ablation)
15.1011
Patient 3: Arm A (MRI-guided Laser Ablation)
7.5436
Patient 5: Arm A (MRI-guided Laser Ablation)
206.8570
Patient 6: Arm A (MRI-guided Laser Ablation)
13.5989
14 weeks
Group
Value
95% CI
Patient 1: Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide)
6.1692
Serum Biomarkers of Peritumoral Blood Brain Barrier (BBB) Disruption as Measured by Change in S100BSecondary· Up to 48 weeks post MRI-guided laser heat ablation (Arm A) or up to 2 years post MRI-guided laser heat ablation (Arm B)
* Arm A patients had blood drawn at the following time points: baseline, 3 days post-MLA, 2-4 weeks post-MLA, and every 12 weeks thereafter for 12 months post-MLA
* Arm B patients had blood drawn at the following time points: baseline, 3 days post-MLA, week 1, week 2, week 3, week 4, week 5, week 6, and every 8 weeks for the first 2 years or until disease progression, whichever occurs first.
* S100b is a low-molecular-weight Calcium-binding protein primarily found in astrocytic glial cells of the CNS. It is secreted by astrocytes for neuroprotective and -trophic cellular functions in the CNS.
Baseline
Group
Value
95% CI
Patient 4: Arm A (MRI-guided Laser Ablation)
79.74
Day 3
Group
Value
95% CI
Patient 1: Arm A (MRI-guided Laser Ablation)
39.90
Patient 4: Arm A (MRI-guided Laser Ablation)
58.86
Patient 1: Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide)
35.90
2-4 weeks
Group
Value
95% CI
Patient 4: Arm A (MRI-guided Laser Ablation)
55.74
12 weeks
Group
Value
95% CI
Patient 1: Arm A (MRI-guided Laser Ablation)
156.00
Patient 4: Arm A (MRI-guided Laser Ablation)
59.78
Patient 5: Arm A (MRI-guided Laser Ablation)
239.13
24 weeks
Group
Value
95% CI
Patient 4: Arm A (MRI-guided Laser Ablation)
65.91
36 weeks
Group
Value
95% CI
Patient 4: Arm A (MRI-guided Laser Ablation)
55.66
48 weeks
Group
Value
95% CI
Patient 4: Arm A (MRI-guided Laser Ablation)
79.11
Serum Biomarkers of Peritumoral Blood Brain Barrier (BBB) Disruption as Measured by Change in GFAPSecondary· Up to 48 weeks post MRI-guided laser heat ablation (Arm A) or up to 2 years post MRI-guided laser heat ablation (Arm B)
* Arm A patients had blood drawn at the following time points: baseline, 3 days post-MLA, 2-4 weeks post-MLA, and every 12 weeks thereafter for 12 months post-MLA
* Arm B patients had blood drawn at the following time points: baseline, 3 days post-MLA, week 1, week 2, week 3, week 4, week 5, week 6, and every 8 weeks for the first 2 years or until disease progression, whichever occurs first.
* The glial fibrillary acidic protein (GFAP) is a classic intermediate filament protein specific to astrocytes in the CNS. GFAP is characteristic of astrocyte- and neural stem cell-derived gliomas in CNS t
Day 3
Group
Value
95% CI
Patient 1: Arm A (MRI-guided Laser Ablation)
4.7370968
Patient 3: Arm A (MRI-guided Laser Ablation)
1.6146649
Patient 5: Arm A (MRI-guided Laser Ablation)
0.2225989
Patient 1: Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide)
5.6051762
2-4 weeks
Group
Value
95% CI
Patient 1: Arm A (MRI-guided Laser Ablation)
0.0652591
Adverse events — posted to ClinicalTrials.gov
Time frame: -Reportable adverse events will be tracked for 30 days following the last day of study treatment for patients in Arm B and for 30 days following the MLA for patients in Arm A. -All-cause mortality will be collected from start of treatment up to 5 years after start of treatment (median length of follow-up 413.5 days, full range 366 days-1801 days)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Arm A (MRI-guided Laser Ablation)
Serious: 0/5 (0%)
Deaths: 0/5
Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Washington University School of Medicine
Last refreshed: 1 November 2024
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