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

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.

Study Overview

• Status: Completed
• Conditions: Brain Metastases

• Study Type: Observational
• Enrollment (Actual): 184

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHRU de Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Restrospective inclusion of all patients treated with intra-cranial SRT for brain metastases from 2014 to 2018 in our single institution

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Once, at the time of treatment delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	Once, at the time of treatment delivery

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 16, 2020
• Primary Completion (ACTUAL): August 17, 2020
• Study Completion (ACTUAL): August 17, 2020

Study Registration Dates

• First Submitted: August 17, 2020
• First Submitted That Met QC Criteria: August 20, 2020
• First Posted (ACTUAL): August 25, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 25, 2020
• Last Update Submitted That Met QC Criteria: August 20, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: SBRT-IRM ( 29BRC20.0156)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication.
• IPD Sharing Time Frame: Data will be available beginning 2 months and ending five years following the final study report completion.
• IPD Sharing Access Criteria: Data access request will be reviewed by the internal committee of Brest University Hospital. Requestor will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No