TriangleNCT02372409 · OUTCOME
Change in Quality of Life as Measured by Karnofsky or Lansky Performance Status
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- score on a scale
- Interval / dispersion
- Not reported
- Time frame
- At 1 year post-MLA
What was measured
Score ranges from 100% to 10%. A higher score indicates that the patient has a more normal quality of life.
Analysis population: This data was not collected on the patient from Arm B.
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 2: 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 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 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
| Group | Source count |
|---|---|
| Patient 1: Arm A (MRI-guided Laser Ablation) | 1 |
| Patient 2: Arm A (MRI-guided Laser Ablation) | 1 |
| Patient 3: Arm A (MRI-guided Laser Ablation) | 1 |
| Patient 4: Arm A (MRI-guided Laser Ablation) | 1 |
| Patient 5: Arm A (MRI-guided Laser Ablation) | 1 |
Reported measurements
Baseline
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Patient 1: Arm A (MRI-guided Laser Ablation) | 90 | Not reported | Not reported | Not reported | Not reported |
| Patient 2: Arm A (MRI-guided Laser Ablation) | 100 | Not reported | Not reported | Not reported | Not reported |
| Patient 3: Arm A (MRI-guided Laser Ablation) | 80 | Not reported | Not reported | Not reported | Not reported |
| Patient 4: Arm A (MRI-guided Laser Ablation) | 100 | Not reported | Not reported | Not reported | Not reported |
| Patient 5: Arm A (MRI-guided Laser Ablation) | 100 | Not reported | Not reported | Not reported | Not reported |
1 year post-MLA
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Patient 1: Arm A (MRI-guided Laser Ablation) | 90 | Not reported | Not reported | Not reported | Not reported |
| Patient 2: Arm A (MRI-guided Laser Ablation) | 100 | Not reported | Not reported | Not reported | Not reported |
| Patient 3: Arm A (MRI-guided Laser Ablation) | 80 | Not reported | Not reported | Not reported | Not reported |
| Patient 4: Arm A (MRI-guided Laser Ablation) | 100 | Not reported | Not reported | Not reported | Not reported |
| Patient 5: Arm A (MRI-guided Laser Ablation) | 100 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 90
- group Id
- OG001
- value
- 100
- group Id
- OG002
- value
- 80
- group Id
- OG003
- value
- 100
- group Id
- OG004
- value
- 100
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- value
- 90
- group Id
- OG001
- value
- 100
- group Id
- OG002
- value
- 80
- group Id
- OG003
- value
- 100
- group Id
- OG004
- value
- 100
- title
- 1 year post-MLA
- 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
- units
- Participants
- description
- Score ranges from 100% to 10%. A higher score indicates that the patient has a more normal quality of life.
- 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 2: 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 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
- OG004
- title
- Patient 5: Arm A (MRI-guided Laser Ablation)
- param Type
- NUMBER
- population Description
- This data was not collected on the patient from Arm B.
- reporting Status
- POSTED
- time Frame
- At 1 year post-MLA
- title
- Change in Quality of Life as Measured by Karnofsky or Lansky Performance Status
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice