Brain MetastasesSBRT-IRMNCT04525053
Dosimetric Validation of Scans Generated by GAN From Pre-therapeutic MRI in Stereotactic Cerebral Radiotherapy
An observational study of Brain Metastases, run by University Hospital, Brest at 1 site in France.
Trial summary
Stereotactic radiotherapy (SRT) is being widely accepted as a treatment of choice for patients with a small number of brain metastases and an acceptable size, allowing a better target dose conformity resulting in high local control rates and better sparing of organs at risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases
- How many people
- 184 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jul 2020to 17 Aug 2020
- 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: Restrospective inclusion of all patients treated with intra-cranial SRT for brain metastases from 2014 to 2018 in our single institution
Who may be able to join
- age ≥ 18 years old
- SRT treatment for one or more brain metastasis(ses)
- brain MRI and planning CT scans realized less than 14 days prior to the treatment delivery
Who cannot join
- MRI's field of view (FOV) judged insufficient for tumour(s) and OAR visualization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dosimetric Validation of Scans Generated by GAN From Pre-therapeutic MRI in Stereotactic Cerebral Radiotherapy (SBRT-IRM)
Stereotactic radiotherapy (SRT) is being widely accepted as a treatment of choice for patients with a small number of brain metastases and an acceptable size, allowing a better target dose conformity resulting in high local control rates and better sparing of organs at risk. Currently, imaging for such a delivery technique requires both a recent magnetic resonance imaging (MRI) brain study for volume definition and a computed tomography (CT) scan for SRT planning. An MRI-only workflow could reduce the risk of misalignment between the two imaging modalities and shorten the delay of planning. Given the absence of a calibrated electronic density on MRI, the investigators aim to assess the equivalence of synthetic CTs generated by a generative adversarial network (GAN) for planning in the brain SRT setting.
- Conditions
- Brain Metastases
- Medical subject headings
- Brain Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Gamma Analysis Passing Rate
To be considered as comparable, 2 dose maps must have a Local Gamma Analysis Passing Rate higher than 98%. The primary outcome measure will be to compare the Local Gamma Analysis Passing Rate between the 2 dose maps (one initial dosimetric planification and one dosimetric planification extracted from the synthetic ct scan).
Measured: Once, at the time of treatment delivery
Secondary outcomes (3)
Global Gamma Analysis Passing Rate
To be considered as comparable, 2 dose maps must have a Global Gamma Analysis Passing Rate higher than 95%. The primary outcome measure will be to compare the Global Gamma Analysis Passing Rate between the 2 dose maps (one initial dosimetric planification and one dosimetric planification extracted from the synthetic ct scan).
Measured: Once, at the time of treatment delivery
Planning Target Volume's coverage values
Planning Target Volume's (PTV) coverage values will be compared between the initial dosimetric planification and the dosimetric planification extracted from the synthetic ct scan.
Measured: Once, at the time of treatment delivery
Organs at risk Dose Constraints
Dose constraints to the Organs at Risks (OAR) will be compared between the initial dosimetric planification and the dosimetric planification extracted from the synthetic ct scan.
Measured: Once, at the time of treatment delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start16 Jul 2020
- Primary completion17 Aug 2020
- Study completion17 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525053
- Sponsor's protocol ID
- SBRT-IRM ( 29BRC20.0156)
- Acronym
- SBRT-IRM
- Status last verified
- Aug 2020
- First submitted
- 17 Aug 2020
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dosimetric Validation of Scans Generated by GAN From Pre-therapeutic MRI in Stereotactic Cerebral Radiotherapy (SBRT-IRM)
- ClinicalTrials.gov ID
- NCT04525053
- Acronym / sponsor ID
- SBRT-IRM / SBRT-IRM ( 29BRC20.0156)
- Conditions
- Brain Metastases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- 17 Aug 2020 (actual)
- Study completion
- 17 Aug 2020 (actual)
- First posted
- 25 Aug 2020 (actual)
- 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.
Stereotactic radiotherapy (SRT) is being widely accepted as a treatment of choice for patients with a small number of brain metastases and an acceptable size, allowing a better target dose conformity resulting in high local control rates and better sparing of organs at risk. Currently, imaging for such a delivery technique requires both a recent magnetic resonance imaging (MRI) brain study for volume definition and a computed tomography (CT) scan for SRT planning. An MRI-only workflow could reduce the risk of misalignment between the two imaging modalities and shorten the delay of planning. Given the absence of a calibrated electronic density on MRI, the investigators aim to assess the equivalence of synthetic CTs generated by a generative adversarial network (GAN) for planning in the brain SRT setting.
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
- Restrospective inclusion of all patients treated with intra-cranial SRT for brain metastases from 2014 to 2018 in our single institution
Key inclusion criteria (3 listed)
- age ≥ 18 years old
- SRT treatment for one or more brain metastasis(ses)
- brain MRI and planning CT scans realized less than 14 days prior to the treatment delivery
Key exclusion criteria (1 listed)
- MRI's field of view (FOV) judged insufficient for tumour(s) and OAR visualization
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
Local Gamma Analysis Passing Rate
Time frame: Once, at the time of treatment delivery
To be considered as comparable, 2 dose maps must have a Local Gamma Analysis Passing Rate higher than 98%. The primary outcome measure will be to compare the Local Gamma Analysis Passing Rate between the 2 dose maps (one initial dosimetric planification and one dosimetric planification extracted from the synthetic ct scan).
3 secondary outcomes
Global Gamma Analysis Passing Rate
Time frame: Once, at the time of treatment delivery
Planning Target Volume's coverage values
Time frame: Once, at the time of treatment delivery
Organs at risk Dose Constraints
Time frame: Once, at the time of treatment delivery
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 25 Aug 2020.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication.
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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 Brain Metastases, run by University Hospital, Brest at 1 site in France.
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 3 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 25 Aug 2020. 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 France. 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?
Local Gamma Analysis Passing Rate (time frame: Once, at the time of treatment delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Aug 2020.