Metastases, NeoplasmNCT02265549
Radiomics for Prediction of Long Term Survival and Local Failure After Stereotactic Radiotherapy for Brain Metastases
An observational study of Metastases, Neoplasm, run by Maastricht Radiation Oncology at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastases, Neoplasm
- How many people
- 155 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2014to 4 Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with 1 upto 4 brain metastases treated with SRT
Who may be able to join
- Cerebral metastasized patients
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Metastases, Neoplasm
- Keywords
- Metastases,, Neoplasm, Cerebral
- Medical subject headings
- Neoplasm Metastasis, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
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.
Measured: 1 year
Secondary outcomes (3)
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2014 (estimated)
- Study startMay 2014
- Primary completion4 Sep 2014
- Study completion4 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Metastases, NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02265549
- Sponsor's protocol ID
- Radiomics SRT 09-2014
- Status last verified
- Jan 2018
- First submitted
- 1 Oct 2014
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 23522151Rodrigues 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.
PubMed 23429647Aerts 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.
PubMed 24892406
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Radiomics for the Prediction of Long Term Survival and Local Failure After Stereotactic Radiotherapy (SRT) for Brain Metastases
- ClinicalTrials.gov ID
- NCT02265549
- Acronym / sponsor ID
- Radiomics SRT 09-2014
- Conditions
- Metastases, Neoplasm
- Keywords
- Metastases,, Neoplasm, Cerebral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- 4 Sep 2014 (actual)
- Study completion
- 4 Sep 2014 (actual)
- First posted
- 16 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with 1 upto 4 brain metastases treated with SRT
Key inclusion criteria (1 listed)
- Cerebral metastasized patients
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
3 secondary outcomes
Specificity 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.
Time frame: 1 year
Negative predictive value of 12 months survival and local failure after stereotactic radiotherapy for brain metastases with radiomics.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- Results publication: PubMed 23522151Zindler 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.
- Results publication: PubMed 23429647Rodrigues 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.
- Results publication: PubMed 24892406Aerts 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastases, Neoplasm, run by Maastricht Radiation Oncology at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitive value of 12 months survival after stereotactic radiotherapy for brain metastases with radiomics (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02265549, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2018.