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NCT02372409 · OUTCOME

Serum Biomarkers of Peritumoral Blood Brain Barrier (BBB) Disruption as Measured by Change in GFAP

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 · Source last updated 2024-11-01

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
ng/ml
Interval / dispersion
Not reported
Time frame
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)

What was measured

* 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.

Analysis population: 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.

Groups in this outcome

Patient 1: Arm A (MRI-guided Laser Ablation)

* 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. * 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 12 weeks (+/- 7 days) for the first year or until disease progression

Patient 4: Arm A (MRI-guided Laser Ablation)

* 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. * 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 12 weeks (+/- 7 days) for the first year or until disease progression

Patient 3: Arm A (MRI-guided Laser Ablation)

* 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. * 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 12 weeks (+/- 7 days) for the first year or until disease progression

Patient 5: Arm A (MRI-guided Laser Ablation)

* 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. * 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 12 weeks (+/- 7 days) for the first year or until disease progression

Patient 6: Arm A (MRI-guided Laser Ablation)

* 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. * 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 12 weeks (+/- 7 days) for the first year or until disease progression

Patient 1: Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide)

* 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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Patient 1: Arm A (MRI-guided Laser Ablation)1
Patient 4: Arm A (MRI-guided Laser Ablation)0
Patient 3: Arm A (MRI-guided Laser Ablation)1
Patient 5: Arm A (MRI-guided Laser Ablation)1
Patient 6: Arm A (MRI-guided Laser Ablation)0
Patient 1: Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide)1

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
Patient 1: Arm A (MRI-guided Laser Ablation)0
Patient 4: Arm A (MRI-guided Laser Ablation)0
Patient 3: Arm A (MRI-guided Laser Ablation)0
Patient 5: Arm A (MRI-guided Laser Ablation)0
Patient 6: Arm A (MRI-guided Laser Ablation)0
Patient 1: Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide)0
Day 3

Analysis denominator · Participants

GroupSource count
Patient 1: Arm A (MRI-guided Laser Ablation)1
Patient 4: Arm A (MRI-guided Laser Ablation)0
Patient 3: Arm A (MRI-guided Laser Ablation)1
Patient 5: Arm A (MRI-guided Laser Ablation)1
Patient 6: Arm A (MRI-guided Laser Ablation)0
Patient 1: Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide)1
Values in ng/ml · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patient 1: Arm A (MRI-guided Laser Ablation)4.7370968Not reportedNot reportedNot reportedNot reported
Patient 3: Arm A (MRI-guided Laser Ablation)1.6146649Not reportedNot reportedNot reportedNot reported
Patient 5: Arm A (MRI-guided Laser Ablation)0.2225989Not reportedNot reportedNot reportedNot reported
Patient 1: Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide)5.6051762Not reportedNot reportedNot reportedNot reported
2-4 weeks

Analysis denominator · Participants

GroupSource count
Patient 1: Arm A (MRI-guided Laser Ablation)1
Patient 4: Arm A (MRI-guided Laser Ablation)0
Patient 3: Arm A (MRI-guided Laser Ablation)0
Patient 5: Arm A (MRI-guided Laser Ablation)0
Patient 6: Arm A (MRI-guided Laser Ablation)0
Patient 1: Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide)0
Values in ng/ml · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patient 1: Arm A (MRI-guided Laser Ablation)0.0652591Not reportedNot reportedNot reportedNot reported
12 weeks

Analysis denominator · Participants

GroupSource count
Patient 1: Arm A (MRI-guided Laser Ablation)0
Patient 4: Arm A (MRI-guided Laser Ablation)0
Patient 3: Arm A (MRI-guided Laser Ablation)0
Patient 5: Arm A (MRI-guided Laser Ablation)0
Patient 6: Arm A (MRI-guided Laser Ablation)0
Patient 1: Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide)0
24 weeks

Analysis denominator · Participants

GroupSource count
Patient 1: Arm A (MRI-guided Laser Ablation)0
Patient 4: Arm A (MRI-guided Laser Ablation)0
Patient 3: Arm A (MRI-guided Laser Ablation)0
Patient 5: Arm A (MRI-guided Laser Ablation)0
Patient 6: Arm A (MRI-guided Laser Ablation)0
Patient 1: Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide)0
36 weeks

Analysis denominator · Participants

GroupSource count
Patient 1: Arm A (MRI-guided Laser Ablation)0
Patient 4: Arm A (MRI-guided Laser Ablation)0
Patient 3: Arm A (MRI-guided Laser Ablation)0
Patient 5: Arm A (MRI-guided Laser Ablation)0
Patient 6: Arm A (MRI-guided Laser Ablation)0
Patient 1: Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide)0
48 weeks

Analysis denominator · Participants

GroupSource count
Patient 1: Arm A (MRI-guided Laser Ablation)0
Patient 4: Arm A (MRI-guided Laser Ablation)0
Patient 3: Arm A (MRI-guided Laser Ablation)0
Patient 5: Arm A (MRI-guided Laser Ablation)0
Patient 6: Arm A (MRI-guided Laser Ablation)0
Patient 1: Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide)0
Complete source fields
classes
  1. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4.7370968
      2. group Id
        OG002
        value
        1.6146649
      3. group Id
        OG003
        value
        0.2225989
      4. group Id
        OG005
        value
        5.6051762
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        1
      units
      Participants
    title
    Day 3
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0652591
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      units
      Participants
    title
    2-4 weeks
  4. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      units
      Participants
    title
    12 weeks
  5. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      units
      Participants
    title
    24 weeks
  6. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      units
      Participants
    title
    36 weeks
  7. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      units
      Participants
    title
    48 weeks
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      1
    5. group Id
      OG004
      value
      0
    6. group Id
      OG005
      value
      1
    units
    Participants
description
* 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.
groups
  1. description
    * 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. * 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 12 weeks (+/- 7 days) for the first year or until disease progression
    id
    OG000
    title
    Patient 1: Arm A (MRI-guided Laser Ablation)
  2. description
    * 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. * 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 12 weeks (+/- 7 days) for the first year or until disease progression
    id
    OG001
    title
    Patient 4: Arm A (MRI-guided Laser Ablation)
  3. description
    * 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. * 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 12 weeks (+/- 7 days) for the first year or until disease progression
    id
    OG002
    title
    Patient 3: Arm A (MRI-guided Laser Ablation)
  4. description
    * 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. * 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 12 weeks (+/- 7 days) for the first year or until disease progression
    id
    OG003
    title
    Patient 5: Arm A (MRI-guided Laser Ablation)
  5. description
    * 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. * 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 12 weeks (+/- 7 days) for the first year or until disease progression
    id
    OG004
    title
    Patient 6: Arm A (MRI-guided Laser Ablation)
  6. description
    * 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
    id
    OG005
    title
    Patient 1: Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide)
param Type
NUMBER
population Description
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.
reporting Status
POSTED
time Frame
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)
title
Serum Biomarkers of Peritumoral Blood Brain Barrier (BBB) Disruption as Measured by Change in GFAP
type
SECONDARY
unit Of Measure
ng/ml

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice