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NCT02372409 · OUTCOME

Serum Biomarkers of Peritumoral Blood Brain Barrier (BBB) Disruption as Measured by Change in S100B

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
pg/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. * 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.

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 S100B 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)1
Patient 3: Arm A (MRI-guided Laser Ablation)0
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)1
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 pg/ml · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patient 4: Arm A (MRI-guided Laser Ablation)79.74Not reportedNot reportedNot reportedNot reported
Day 3

Analysis denominator · Participants

GroupSource count
Patient 1: Arm A (MRI-guided Laser Ablation)1
Patient 4: Arm A (MRI-guided Laser Ablation)1
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)1
Values in pg/ml · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patient 1: Arm A (MRI-guided Laser Ablation)39.90Not reportedNot reportedNot reportedNot reported
Patient 4: Arm A (MRI-guided Laser Ablation)58.86Not reportedNot reportedNot reportedNot reported
Patient 1: Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide)35.90Not reportedNot reportedNot reportedNot reported
2-4 weeks

Analysis denominator · Participants

GroupSource count
Patient 1: Arm A (MRI-guided Laser Ablation)0
Patient 4: Arm A (MRI-guided Laser Ablation)1
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 pg/ml · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patient 4: Arm A (MRI-guided Laser Ablation)55.74Not reportedNot reportedNot reportedNot reported
12 weeks

Analysis denominator · Participants

GroupSource count
Patient 1: Arm A (MRI-guided Laser Ablation)1
Patient 4: Arm A (MRI-guided Laser Ablation)1
Patient 3: Arm A (MRI-guided Laser Ablation)0
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)0
Values in pg/ml · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patient 1: Arm A (MRI-guided Laser Ablation)156.00Not reportedNot reportedNot reportedNot reported
Patient 4: Arm A (MRI-guided Laser Ablation)59.78Not reportedNot reportedNot reportedNot reported
Patient 5: Arm A (MRI-guided Laser Ablation)239.13Not reportedNot reportedNot reportedNot reported
24 weeks

Analysis denominator · Participants

GroupSource count
Patient 1: Arm A (MRI-guided Laser Ablation)0
Patient 4: Arm A (MRI-guided Laser Ablation)1
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 pg/ml · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patient 4: Arm A (MRI-guided Laser Ablation)65.91Not reportedNot reportedNot reportedNot reported
36 weeks

Analysis denominator · Participants

GroupSource count
Patient 1: Arm A (MRI-guided Laser Ablation)0
Patient 4: Arm A (MRI-guided Laser Ablation)1
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 pg/ml · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patient 4: Arm A (MRI-guided Laser Ablation)55.66Not reportedNot reportedNot reportedNot reported
48 weeks

Analysis denominator · Participants

GroupSource count
Patient 1: Arm A (MRI-guided Laser Ablation)0
Patient 4: Arm A (MRI-guided Laser Ablation)1
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 pg/ml · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patient 4: Arm A (MRI-guided Laser Ablation)79.11Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        value
        79.74
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      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
        39.90
      2. group Id
        OG001
        value
        58.86
      3. group Id
        OG005
        value
        35.90
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        1
      units
      Participants
    title
    Day 3
  3. categories
    1. measurements
      1. group Id
        OG001
        value
        55.74
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      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. categories
    1. measurements
      1. group Id
        OG000
        value
        156.00
      2. group Id
        OG001
        value
        59.78
      3. group Id
        OG003
        value
        239.13
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      units
      Participants
    title
    12 weeks
  5. categories
    1. measurements
      1. group Id
        OG001
        value
        65.91
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      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. categories
    1. measurements
      1. group Id
        OG001
        value
        55.66
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      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. categories
    1. measurements
      1. group Id
        OG001
        value
        79.11
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      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
      1
    3. group Id
      OG002
      value
      0
    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. * 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.
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 S100B 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 S100B
type
SECONDARY
unit Of Measure
pg/ml

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Preserved source evidence · Not medical advice