Trial · NCT02372409
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, Phase 2, Terminated, Washington University School of Medicine; results first posted 2024-08-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT02372409. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02372409
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT02372409
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Glioma, Pilocytic Astrocytoma, Anaplastic Astrocytoma, Glioblastoma, Mixed Oligoastrocytoma, Mixed Glioma, Oligodendroglioma, Optic Glioma, Astrocytoma
- Interventions
- MRI-guided laser ablation, Doxorubicin, Etoposide, Dynamic contrast-enhanced (DCE) MRI, Dynamic susceptibility contrast (DSC) MRI
- First posted
- 2015-02-26
- Last updated
- 2024-11-01
- Results first posted
- 2024-08-09
- Limitations and caveats
The protocol stated that participants were to be followed for 5 years from participant registration or until death, whichever occurred first. The original consent that the participants signed stated that they would only be followed for 12 months after MLA. Once this issue was discovered, participants were contacted to be reconsented to be followed for 5 years; however, not all participants were able to be reconsented and that is why the results are late.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Arm A Only: Number of Participants With Progression-free Survival (PFS) | 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. |
| Primary | Arm A Only: Overall Survival (OS) as Measured by Number of Participants Alive at 5 Years | Up to 5 years from date of registration (median length of follow-up, full range 196 days-1801 days) | |
| Primary | Arm B Only: Number of Participants With Progression-free Survival (PFS) | At 6 months | PFS is followed from start of treatment to time of progression or death, whichever occurs first. |
| Secondary | Change in Quality of Life as Measured by Karnofsky or Lansky Performance Status | 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. |
| Secondary | Serum Biomarkers of Peritumoral Blood Brain Barrier (BBB) Disruption as Measured by Change in Neuron-specific Enolase (NSE) | 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 serum NSE seemed to correlates with disruption in BBB following MLA and transient increase in BBB permeability. |
| Secondary | Serum Biomarkers of Peritumoral Blood Brain Barrier (BBB) Disruption as Measured by Change in S100B | 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. Elevated serum values can be associated with temporal changes in BBB integrity following MLA. |
| Secondary | Serum Biomarkers of Peritumoral Blood Brain Barrier (BBB) Disruption as Measured by Change in GFAP | 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 tumors and is used to identify malignancies of glial origin, such as astrocytomas and GBM. Serum GFAP values can be increased with temporal disruption of BBB post-MLA. |
| Secondary | Correlation of MR Imaging With Peritumoral BBB Disruption | 1 year from MLA | The linear regression model will used to investigate the correlation between MR imaging and peritumoral BBB disruption. To account for correlation among the repeated measures from the same patient, the longitudinal data will be analyzed with the use of linear generalized estimating equation (GEE). Whether the average measurements differ at the multiple time points will be evaluated through GEE model. Least-square means at each time points will be presented and standard errors will be calculated within the use of the GEE sandwich method when accounting for within-patient correlation. |
| Secondary | Predictive Value of the Peritumoral Permeability Score for Patient Outcome as Measured by PFS | 6 months | Biomarkers with higher correlation coefficient (r approaching 1) will be given higher priority. A minimum r=0.5 is required for inclusion for further analysis and will be used as a peritumoral permeability score. This score will then be correlated with the patient outcome data (as measured by 6 month PFS rate) to determine whether it has a predictive value. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Arm A Only: Number of Participants With Progression-free Survival (PFS) | Up to 5 years from date of registration (median length of follow-up, full range 196 days-1801 days) | This outcome measure is for Arm A participants only. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Arm A Only: Overall Survival (OS) as Measured by Number of Participants Alive at 5 Years | Up to 5 years from date of registration (median length of follow-up, full range 196 days-1801 days) | This outcome measure is for Arm A participants only. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Arm B Only: Number of Participants With Progression-free Survival (PFS) | At 6 months | This outcome measure is for Arm B participants only. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Quality of Life as Measured by Karnofsky or Lansky Performance Status | At 1 year post-MLA | This data was not collected on the patient from Arm B. | score on a scale | NUMBER |
| SECONDARY | Serum Biomarkers of Peritumoral Blood Brain Barrier (BBB) Disruption as Measured by Change in Neuron-specific Enolase (NSE) | 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) | The one participant in Arm B did not consent to any procedures past 12 months post-MLA. There are time points not included because either the NSE was not detected in the samples or the samples were not collected. | ng/ml | NUMBER |
| SECONDARY | Serum Biomarkers of Peritumoral Blood Brain Barrier (BBB) Disruption as Measured by Change in S100B | 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) | The one participant in Arm B did not consent to any procedures past 12 months post-MLA. There are time points not included because either the S100B was not detected in the samples or the samples were not collected. | pg/ml | NUMBER |
| SECONDARY | Serum Biomarkers of Peritumoral Blood Brain Barrier (BBB) Disruption as Measured by Change in GFAP | 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) | The one participant in Arm B did not consent to any procedures past 12 months post-MLA. There are time points not included because either the GFAP was not detected in the samples or the samples were not collected. | ng/ml | NUMBER |
| SECONDARY | Correlation of MR Imaging With Peritumoral BBB Disruption | 1 year from MLA | Data was not collected for this outcome measure. | ||
| SECONDARY | Predictive Value of the Peritumoral Permeability Score for Patient Outcome as Measured by PFS | 6 months | Data was not collected for this outcome measure. |
Source ClinicalTrials.gov
Results by group73
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Arm A Only: Number of Participants With Progression-free Survival (PFS) | Arm A (MRI-guided Laser Ablation) | 4 | Participants | ||
| Arm A Only: Overall Survival (OS) as Measured by Number of Participants Alive at 5 Years | Arm A (MRI-guided Laser Ablation) | 5 | Participants | ||
| Arm B Only: Number of Participants With Progression-free Survival (PFS) | Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide) | 0 | Participants | ||
| Change in Quality of Life as Measured by Karnofsky or Lansky Performance Status | Patient 1: Arm A (MRI-guided Laser Ablation) | Baseline | 90 | score on a scale | |
| Change in Quality of Life as Measured by Karnofsky or Lansky Performance Status | Patient 2: Arm A (MRI-guided Laser Ablation) | Baseline | 100 | score on a scale | |
| Change in Quality of Life as Measured by Karnofsky or Lansky Performance Status | Patient 3: Arm A (MRI-guided Laser Ablation) | Baseline | 80 | score on a scale | |
| Change in Quality of Life as Measured by Karnofsky or Lansky Performance Status | Patient 4: Arm A (MRI-guided Laser Ablation) | Baseline | 100 | score on a scale | |
| Change in Quality of Life as Measured by Karnofsky or Lansky Performance Status | Patient 5: Arm A (MRI-guided Laser Ablation) | Baseline | 100 | score on a scale | |
| Change in Quality of Life as Measured by Karnofsky or Lansky Performance Status | Patient 1: Arm A (MRI-guided Laser Ablation) | 1 year post-MLA | 90 | score on a scale | |
| Change in Quality of Life as Measured by Karnofsky or Lansky Performance Status | Patient 2: Arm A (MRI-guided Laser Ablation) | 1 year post-MLA | 100 | score on a scale |
1 to 10 of 73Source ClinicalTrials.gov
See all 73 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (MRI-guided Laser Ablation) | 5 | |
| Overall Study | STARTED | Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide) | 1 | |
| Overall Study | COMPLETED | Arm A (MRI-guided Laser Ablation) | 3 | |
| Overall Study | COMPLETED | Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide) | 0 | |
| Overall Study | NOT COMPLETED | Arm A (MRI-guided Laser Ablation) | 2 | |
| Overall Study | NOT COMPLETED | Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide) | 1 |
Source ClinicalTrials.gov
Adverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fecal incontinence | Gastrointestinal disorders | Arm A (MRI-guided Laser Ablation) | 1 | 5 | |
| other | Fecal incontinence | Gastrointestinal disorders | Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide) | 0 | 1 | |
| other | Fatigue | General disorders | Arm A (MRI-guided Laser Ablation) | 1 | 5 | |
| other | Fatigue | General disorders | Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide) | 0 | 1 | |
| other | Headache | Nervous system disorders | Arm A (MRI-guided Laser Ablation) | 1 | 5 | |
| other | Headache | Nervous system disorders | Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide) | 0 | 1 | |
| other | Paresthesia | Nervous system disorders | Arm A (MRI-guided Laser Ablation) | 1 | 5 | |
| other | Paresthesia | Nervous system disorders | Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide) | 0 | 1 | |
| other | Memory impairment | Nervous system disorders | Arm A (MRI-guided Laser Ablation) | 1 | 5 | |
| other | Memory impairment | Nervous system disorders | Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide) | 0 | 1 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (MRI-guided Laser Ablation) | 0 | 5 |
| Total, all-cause mortality | Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide) | 0 | 1 |
| Total, other adverse events | Arm A (MRI-guided Laser Ablation) | 5 | 5 |
| Total, other adverse events | Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide) | 0 | 1 |
| Total, serious adverse events | Arm A (MRI-guided Laser Ablation) | 0 | 5 |
| Total, serious adverse events | Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide) | 0 | 1 |
Source ClinicalTrials.gov
Papers12
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A (MRI-guided Laser Ablation) vs Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide): deaths from any cause | Trial comparisons |
| Arm A (MRI-guided Laser Ablation) vs Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02372409
GET https://conductscience.org/api/trials/v1/NCT02372409/results?page=2