- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02265549
Radiomics for Prediction of Long Term Survival and Local Failure After Stereotactic Radiotherapy for Brain Metastases
January 25, 2018 updated by: Maastricht Radiation Oncology
Value of Radiomics for the Prediction of Long Term Survival and Local Failure After Stereotactic Radiotherapy (SRT) for Brain Metastases
Published prognostic scores have limitations in prediction of long term survival after stereotactic radiotherapy for brain metastases.
Moreover, no validated tools are available for prediction of local failure.
The value of radiomics is evaluated in this perspective.
Study Overview
Status
Completed
Conditions
Detailed Description
Sensitivity is low for prediction of long term survival of currently available prognostic scores for brain metastases.
First the current clinical models will be optimized with a new prognostic model and nomogram.
Radiomics is a tool to analyze tumor characteristics based on CT and MR images.
These tumor characteristics may reflect tumor biology and outcome.
Therefore it is investigated if radiomics improves prediction of long term survival after stereotactic radiotherapy for brain metastases.
Moreover, the predictive value of radiomics for local failure is investigated.
Study Type
Observational
Enrollment (Actual)
155
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Maastricht, Netherlands, 6229 ET
- Maastro clinic
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with 1 upto 4 brain metastases treated with SRT
Description
Inclusion Criteria:
- Cerebral metastasized patients
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitive value of 12 months survival after stereotactic radiotherapy for brain metastases with radiomics
Time Frame: 1 year
|
Sensitivity of 12 months survival after stereotactic radiotherapy for brain metastases with radiomics.
Radiomics is a tool to analyze tumor characteristics based on CT and MR images.
|
1 year
|
Sensitive value of 12 months local failure after stereotactic radiotherapy for brain metastases with radiomics
Time Frame: 1 year
|
Sensitivity of 12 months local failure after stereotactic radiotherapy for brain metastases with radiomics.
Radiomics is a tool to analyze tumor characteristics based on CT and MR images.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Specificity of 12 months survival and local failure after stereotactic radiotherapy for brain metastases with radiomics.
Time Frame: 1 year
|
Specificity of 12 months survival and local failure after stereotactic radiotherapy for brain metastases with radiomics.
|
1 year
|
Positive predictive value of 12 months survival and local failure after stereotactic radiotherapy for brain metastases with radiomics.
Time Frame: 1 year
|
Positive predictive value of 12 months survival and local failure after stereotactic radiotherapy for brain metastases with radiomics.
|
1 year
|
Negative predictive value of 12 months survival and local failure after stereotactic radiotherapy for brain metastases with radiomics.
Time Frame: 1 year
|
Negative predictive value of 12 months survival and local failure after stereotactic radiotherapy for brain metastases with radiomics.
|
1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area under the curve of published prognostic scores
Time Frame: 1 year
|
Area under the curve published prognostic scores
|
1 year
|
Mismatch rate of published prognostic scores
Time Frame: 1 year
|
Mismatch rate of published prognostic scores
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Zindler JD, Rodrigues G, Haasbeek CJ, De Haan PF, Meijer OW, Slotman BJ, Lagerwaard FJ. The clinical utility of prognostic scoring systems in patients with brain metastases treated with radiosurgery. Radiother Oncol. 2013 Mar;106(3):370-4. doi: 10.1016/j.radonc.2013.01.015. Epub 2013 Mar 20.
- Rodrigues G, Zindler J, Warner A, Lagerwaard F. Recursive partitioning analysis for the prediction of stereotactic radiosurgery brain metastases lesion control. Oncologist. 2013;18(3):330-5. doi: 10.1634/theoncologist.2012-0316. Epub 2013 Feb 19.
- Aerts HJ, Velazquez ER, Leijenaar RT, Parmar C, Grossmann P, Carvalho S, Bussink J, Monshouwer R, Haibe-Kains B, Rietveld D, Hoebers F, Rietbergen MM, Leemans CR, Dekker A, Quackenbush J, Gillies RJ, Lambin P. Decoding tumour phenotype by noninvasive imaging using a quantitative radiomics approach. Nat Commun. 2014 Jun 3;5:4006. doi: 10.1038/ncomms5006. Erratum In: Nat Commun. 2014;5:4644. Cavalho, Sara [corrected to Carvalho, Sara].
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2014
Primary Completion (Actual)
September 4, 2014
Study Completion (Actual)
September 4, 2014
Study Registration Dates
First Submitted
October 1, 2014
First Submitted That Met QC Criteria
October 10, 2014
First Posted (Estimate)
October 16, 2014
Study Record Updates
Last Update Posted (Actual)
January 26, 2018
Last Update Submitted That Met QC Criteria
January 25, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Radiomics SRT 09-2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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