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Completed

NCT Number: NCT04525053

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

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.

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Key information

Conditions

Brain Metastases Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Brest

Brest, 29609, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

Secondary outcomes

  1. Global Gamma Analysis Passing Rate

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: SBRT-IRM

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 25, 2020
Registry last updated
Aug 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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