Clinical trial NCT02265549: Radiomics for Prediction of Long Term Survival and Local Failure After Stereotactic Radiotherapy for Brain Metastases
Official title: Value of Radiomics for the Prediction of Long Term Survival and Local Failure After Stereotactic Radiotherapy (SRT) for Brain Metastases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastases, Neoplasm
Keywords: Metastases,
Neoplasm
Cerebral
Lead sponsor: Maastricht Radiation Oncology
Sponsor class: OTHER
First posted: 2014-10-16
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with 1 upto 4 brain metastases treated with SRT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Cerebral metastasized patients

Exclusion Criteria:

-

Primary outcomes:
measure: Sensitive value of 12 months survival after stereotactic radiotherapy for brain metastases with radiomics
timeFrame: 1 year
measure: Sensitive value of 12 months local failure after stereotactic radiotherapy for brain metastases with radiomics
timeFrame: 1 year
Secondary outcomes:
measure: Specificity of 12 months survival and local failure after stereotactic radiotherapy for brain metastases with radiomics.
timeFrame: 1 year
measure: Positive predictive value of 12 months survival and local failure after stereotactic radiotherapy for brain metastases with radiomics.
timeFrame: 1 year
measure: Negative predictive value of 12 months survival and local failure after stereotactic radiotherapy for brain metastases with radiomics.
timeFrame: 1 year
Other outcomes:
measure: Area under the curve of published prognostic scores
timeFrame: 1 year
measure: Mismatch rate of published prognostic scores
timeFrame: 1 year
Locations:
city: Maastricht
country: Netherlands
facility: Maastro Clinic
Study officials:
References:
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.radonc.2013.01.015. Epub 2013 Mar 20.
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.
citation: 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.