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SBRT-IRM: Dosimetric Validation of Scans Generated by GAN From Pre-therapeutic MRI in Stereotactic Cerebral Radiotherapy

Sponsor
University Hospital, Brest (Other)
Overall Status
Completed
CT.gov ID
NCT04525053
Collaborator
(none)
184
Enrollment
1
Location
1.1
Actual Duration (Months)
175
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    184 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Dosimetric Validation of Scans Generated by GAN From Pre-therapeutic MRI in Stereotactic Cerebral Radiotherapy (SBRT-IRM)
    Actual Study Start Date :
    Jul 16, 2020
    Actual Primary Completion Date :
    Aug 17, 2020
    Actual Study Completion Date :
    Aug 17, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Local Gamma Analysis Passing Rate [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).

    Secondary Outcome Measures

    1. Global Gamma Analysis Passing Rate [Once, at the time of treatment delivery]

      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).

    2. Planning Target Volume's coverage values [Once, at the time of treatment delivery]

      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.

    3. Organs at risk Dose Constraints [Once, at the time of treatment delivery]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:
    • MRI's field of view (FOV) judged insufficient for tumour(s) and OAR visualization

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHRU de Brest Brest France 29609

    Sponsors and Collaborators

    • University Hospital, Brest

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Brest
    ClinicalTrials.gov Identifier:
    NCT04525053
    Other Study ID Numbers:
    • SBRT-IRM ( 29BRC20.0156)
    First Posted:
    Aug 25, 2020
    Last Update Posted:
    Aug 25, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Brain Neoplasms

    Study Results

    No Results Posted as of Aug 25, 2020