NCT02372409 · OUTCOME
Serum Biomarkers of Peritumoral Blood Brain Barrier (BBB) Disruption as Measured by Change in Neuron-specific Enolase (NSE)
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.
* 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.
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 NSE 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
| Group | Source 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) | 1 |
|---|
| Patient 5: Arm A (MRI-guided Laser Ablation) | 1 |
|---|
| Patient 6: Arm A (MRI-guided Laser Ablation) | 1 |
|---|
| Patient 1: Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide) | 1 |
|---|
Reported measurements
Baseline
Analysis denominator · Participants
| Group | Source 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) | 1 |
|---|
| Patient 5: Arm A (MRI-guided Laser Ablation) | 1 |
|---|
| Patient 6: Arm A (MRI-guided Laser Ablation) | 1 |
|---|
| Patient 1: Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide) | 1 |
|---|
Values in ng/ml · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Patient 1: Arm A (MRI-guided Laser Ablation) | 29.0219 | Not reported | Not reported | Not reported | Not reported |
|---|
| Patient 4: Arm A (MRI-guided Laser Ablation) | 58.3406 | Not reported | Not reported | Not reported | Not reported |
|---|
| Patient 3: Arm A (MRI-guided Laser Ablation) | 3.1823 | Not reported | Not reported | Not reported | Not reported |
|---|
| Patient 5: Arm A (MRI-guided Laser Ablation) | 13.1819 | Not reported | Not reported | Not reported | Not reported |
|---|
| Patient 6: Arm A (MRI-guided Laser Ablation) | 7.5534 | Not reported | Not reported | Not reported | Not reported |
|---|
| Patient 1: Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide) | 11.5114 | Not reported | Not reported | Not reported | Not reported |
|---|
Day 3
Analysis denominator · Participants
| Group | Source 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) | 1 |
|---|
| Patient 5: Arm A (MRI-guided Laser Ablation) | 1 |
|---|
| Patient 6: Arm A (MRI-guided Laser Ablation) | 1 |
|---|
| Patient 1: Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide) | 1 |
|---|
Values in ng/ml · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Patient 1: Arm A (MRI-guided Laser Ablation) | 47.2666 | Not reported | Not reported | Not reported | Not reported |
|---|
| Patient 4: Arm A (MRI-guided Laser Ablation) | 26.7537 | Not reported | Not reported | Not reported | Not reported |
|---|
| Patient 3: Arm A (MRI-guided Laser Ablation) | 6.0443 | Not reported | Not reported | Not reported | Not reported |
|---|
| Patient 5: Arm A (MRI-guided Laser Ablation) | 33.8034 | Not reported | Not reported | Not reported | Not reported |
|---|
| Patient 6: Arm A (MRI-guided Laser Ablation) | 17.4680 | Not reported | Not reported | Not reported | Not reported |
|---|
| Patient 1: Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide) | 18.5711 | Not reported | Not reported | Not reported | Not reported |
|---|
1 week
Analysis denominator · Participants
| Group | Source 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) | 1 |
|---|
Values in ng/ml · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Patient 1: Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide) | 11.5909 | Not reported | Not reported | Not reported | Not reported |
|---|
2 week
Analysis denominator · Participants
| Group | Source 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) | 1 |
|---|
Values in ng/ml · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Patient 1: Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide) | 8.6069 | Not reported | Not reported | Not reported | Not reported |
|---|
2-4 weeks
Analysis denominator · Participants
| Group | Source 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) | 1 |
|---|
| Patient 5: Arm A (MRI-guided Laser Ablation) | 1 |
|---|
| Patient 6: Arm A (MRI-guided Laser Ablation) | 1 |
|---|
| Patient 1: Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide) | 0 |
|---|
Values in ng/ml · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Patient 1: Arm A (MRI-guided Laser Ablation) | 12.0186 | Not reported | Not reported | Not reported | Not reported |
|---|
| Patient 4: Arm A (MRI-guided Laser Ablation) | 53.2519 | Not reported | Not reported | Not reported | Not reported |
|---|
| Patient 3: Arm A (MRI-guided Laser Ablation) | 5.4452 | Not reported | Not reported | Not reported | Not reported |
|---|
| Patient 5: Arm A (MRI-guided Laser Ablation) | 11.4998 | Not reported | Not reported | Not reported | Not reported |
|---|
| Patient 6: Arm A (MRI-guided Laser Ablation) | 9.3916 | Not reported | Not reported | Not reported | Not reported |
|---|
4 week
Analysis denominator · Participants
| Group | Source 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) | 1 |
|---|
Values in ng/ml · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Patient 1: Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide) | 5.7440 | Not reported | Not reported | Not reported | Not reported |
|---|
12 weeks
Analysis denominator · Participants
| Group | Source 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) | 1 |
|---|
| Patient 5: Arm A (MRI-guided Laser Ablation) | 1 |
|---|
| Patient 6: Arm A (MRI-guided Laser Ablation) | 1 |
|---|
| Patient 1: Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide) | 0 |
|---|
Values in ng/ml · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Patient 1: Arm A (MRI-guided Laser Ablation) | 105.7828 | Not reported | Not reported | Not reported | Not reported |
|---|
| Patient 4: Arm A (MRI-guided Laser Ablation) | 15.1011 | Not reported | Not reported | Not reported | Not reported |
|---|
| Patient 3: Arm A (MRI-guided Laser Ablation) | 7.5436 | Not reported | Not reported | Not reported | Not reported |
|---|
| Patient 5: Arm A (MRI-guided Laser Ablation) | 206.8570 | Not reported | Not reported | Not reported | Not reported |
|---|
| Patient 6: Arm A (MRI-guided Laser Ablation) | 13.5989 | Not reported | Not reported | Not reported | Not reported |
|---|
14 weeks
Analysis denominator · Participants
| Group | Source 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) | 1 |
|---|
Values in ng/ml · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Patient 1: Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide) | 6.1692 | Not reported | Not reported | Not reported | Not reported |
|---|
24 weeks
Analysis denominator · Participants
| Group | Source 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) | 1 |
|---|
| Patient 5: Arm A (MRI-guided Laser Ablation) | 1 |
|---|
| Patient 6: Arm A (MRI-guided Laser Ablation) | 1 |
|---|
| Patient 1: Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide) | 0 |
|---|
Values in ng/ml · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Patient 1: Arm A (MRI-guided Laser Ablation) | 19.1706 | Not reported | Not reported | Not reported | Not reported |
|---|
| Patient 4: Arm A (MRI-guided Laser Ablation) | 7.8464 | Not reported | Not reported | Not reported | Not reported |
|---|
| Patient 3: Arm A (MRI-guided Laser Ablation) | 3.8632 | Not reported | Not reported | Not reported | Not reported |
|---|
| Patient 5: Arm A (MRI-guided Laser Ablation) | 5.5086 | Not reported | Not reported | Not reported | Not reported |
|---|
| Patient 6: Arm A (MRI-guided Laser Ablation) | 13.8210 | Not reported | Not reported | Not reported | Not reported |
|---|
36 weeks
Analysis denominator · Participants
| Group | Source 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) | 1 |
|---|
| Patient 1: Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide) | 0 |
|---|
Values in ng/ml · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Patient 1: Arm A (MRI-guided Laser Ablation) | 22.8186 | Not reported | Not reported | Not reported | Not reported |
|---|
| Patient 4: Arm A (MRI-guided Laser Ablation) | 7.9655 | Not reported | Not reported | Not reported | Not reported |
|---|
| Patient 5: Arm A (MRI-guided Laser Ablation) | 10.0722 | Not reported | Not reported | Not reported | Not reported |
|---|
| Patient 6: Arm A (MRI-guided Laser Ablation) | 5.9368 | Not reported | Not reported | Not reported | Not reported |
|---|
48 weeks
Analysis denominator · Participants
| Group | Source 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) | 1 |
|---|
| Patient 1: Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide) | 0 |
|---|
Values in ng/ml · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Patient 1: Arm A (MRI-guided Laser Ablation) | 15.4708 | Not reported | Not reported | Not reported | Not reported |
|---|
| Patient 4: Arm A (MRI-guided Laser Ablation) | 35.6507 | Not reported | Not reported | Not reported | Not reported |
|---|
| Patient 5: Arm A (MRI-guided Laser Ablation) | 25.8530 | Not reported | Not reported | Not reported | Not reported |
|---|
| Patient 6: Arm A (MRI-guided Laser Ablation) | 5.9343 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 29.0219
- group Id
- OG001
- value
- 58.3406
- group Id
- OG002
- value
- 3.1823
- group Id
- OG003
- value
- 13.1819
- group Id
- OG004
- value
- 7.5534
- group Id
- OG005
- value
- 11.5114
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- units
- Participants
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- value
- 47.2666
- group Id
- OG001
- value
- 26.7537
- group Id
- OG002
- value
- 6.0443
- group Id
- OG003
- value
- 33.8034
- group Id
- OG004
- value
- 17.4680
- group Id
- OG005
- value
- 18.5711
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- units
- Participants
- title
- Day 3
- categories
- measurements
- group Id
- OG005
- value
- 11.5909
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- units
- Participants
- title
- 1 week
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- units
- Participants
- title
- 2 week
- categories
- measurements
- group Id
- OG000
- value
- 12.0186
- group Id
- OG001
- value
- 53.2519
- group Id
- OG002
- value
- 5.4452
- group Id
- OG003
- value
- 11.4998
- group Id
- OG004
- value
- 9.3916
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- units
- Participants
- title
- 2-4 weeks
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- units
- Participants
- title
- 4 week
- categories
- measurements
- group Id
- OG000
- value
- 105.7828
- group Id
- OG001
- value
- 15.1011
- group Id
- OG002
- value
- 7.5436
- group Id
- OG003
- value
- 206.8570
- group Id
- OG004
- value
- 13.5989
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- units
- Participants
- title
- 12 weeks
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- units
- Participants
- title
- 14 weeks
- categories
- measurements
- group Id
- OG000
- value
- 19.1706
- group Id
- OG001
- value
- 7.8464
- group Id
- OG002
- value
- 3.8632
- group Id
- OG003
- value
- 5.5086
- group Id
- OG004
- value
- 13.8210
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- units
- Participants
- title
- 24 weeks
- categories
- measurements
- group Id
- OG000
- value
- 22.8186
- group Id
- OG001
- value
- 7.9655
- group Id
- OG003
- value
- 10.0722
- group Id
- OG004
- value
- 5.9368
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- units
- Participants
- title
- 36 weeks
- categories
- measurements
- group Id
- OG000
- value
- 15.4708
- group Id
- OG001
- value
- 35.6507
- group Id
- OG003
- value
- 25.8530
- group Id
- OG004
- value
- 5.9343
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- units
- Participants
- title
- 48 weeks
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- 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.
* 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.
- groups
- 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)
- 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)
- 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)
- 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)
- 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)
- 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 NSE 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 Neuron-specific Enolase (NSE)
- type
- SECONDARY
- unit Of Measure
- ng/ml
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Preserved source evidence · Not medical advice
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