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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02265549
Other study ID # Radiomics SRT 09-2014
Secondary ID
Status Completed
Phase N/A
First received October 1, 2014
Last updated January 25, 2018
Start date May 2014
Est. completion date September 4, 2014

Study information

Verified date January 2018
Source Maastricht Radiation Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 155
Est. completion date September 4, 2014
Est. primary completion date September 4, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Cerebral metastasized patients

Exclusion Criteria:

Study Design


Locations

Country Name City State
Netherlands Maastro Clinic Maastricht

Sponsors (1)

Lead Sponsor Collaborator
Maastricht Radiation Oncology

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

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 imag — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Area under the curve of published prognostic scores Area under the curve published prognostic scores 1 year
Other Mismatch rate of published prognostic scores Mismatch rate of published prognostic scores 1 year
Primary Sensitive value of 12 months survival after stereotactic radiotherapy for brain metastases with radiomics 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
Primary Sensitive value of 12 months local failure after stereotactic radiotherapy for brain metastases with radiomics 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 Specificity of 12 months survival and local failure after stereotactic radiotherapy for brain metastases with radiomics. Specificity of 12 months survival and local failure after stereotactic radiotherapy for brain metastases with radiomics. 1 year
Secondary Positive predictive value of 12 months survival and local failure after stereotactic radiotherapy for brain metastases with radiomics. Positive predictive value of 12 months survival and local failure after stereotactic radiotherapy for brain metastases with radiomics. 1 year
Secondary Negative predictive value of 12 months survival and local failure after stereotactic radiotherapy for brain metastases with radiomics. Negative predictive value of 12 months survival and local failure after stereotactic radiotherapy for brain metastases with radiomics. 1 year
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