TriangleNCT00602667 · OUTCOME
Change in Neurostructure, Especially White Matter Volume and Integrity
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Change in FA per month
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)
What was measured
Quantitative MRI measures Fractional Anisotropy (FA) change per month in left temporal lobe over time in each risk group will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy. Fractional anisotropy (FA) is a scalar unitless measure that quantifies the degree of anisotropy of a diffusion process, particularly in the context of diffusion tensor imaging (DTI) used in MRI scans. FA values range from 0 to 1
Analysis population: Eligible infratentorial medulloblastoma, ependymoma, and pineoblastoma patients(n=75) were included.
Groups in this outcome
Low-Risk Group
Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.
Intermediate-Risk Group
Patients with (M0) medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.
High-Risk Group
Patients with central nervous system (CNS) metastatic disease will receive induction chemotherapy and high-risk therapy.
| Group | Source count |
|---|---|
| Low-Risk Group | 12 |
| Intermediate-Risk Group | 43 |
| High-Risk Group | 20 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Low-Risk Group | 0.0014 | Not reported | 0.0011 | 0.0017 | Not reported |
| Intermediate-Risk Group | 0.0013 | Not reported | 0.0011 | 0.0014 | Not reported |
| High-Risk Group | 0.0014 | Not reported | 0.0011 | 0.0016 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0011
- upper Limit
- 0.0017
- value
- 0.0014
- group Id
- OG001
- lower Limit
- 0.0011
- upper Limit
- 0.0014
- value
- 0.0013
- group Id
- OG002
- lower Limit
- 0.0011
- upper Limit
- 0.0016
- value
- 0.0014
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 43
- group Id
- OG002
- value
- 20
- units
- Participants
- description
- Quantitative MRI measures Fractional Anisotropy (FA) change per month in left temporal lobe over time in each risk group will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy. Fractional anisotropy (FA) is a scalar unitless measure that quantifies the degree of anisotropy of a diffusion process, particularly in the context of diffusion tensor imaging (DTI) used in MRI scans. FA values range from 0 to 1
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.
- id
- OG000
- title
- Low-Risk Group
- description
- Patients with (M0) medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.
- id
- OG001
- title
- Intermediate-Risk Group
- description
- Patients with central nervous system (CNS) metastatic disease will receive induction chemotherapy and high-risk therapy.
- id
- OG002
- title
- High-Risk Group
- param Type
- NUMBER
- population Description
- Eligible infratentorial medulloblastoma, ependymoma, and pineoblastoma patients(n=75) were included.
- reporting Status
- POSTED
- time Frame
- From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)
- title
- Change in Neurostructure, Especially White Matter Volume and Integrity
- type
- SECONDARY
- unit Of Measure
- Change in FA per month
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice