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

• ClinicalTrials.gov Identifier: NCT04525053
• Recruitment Status: Completed
• First Posted: August 25, 2020
• Last Update Posted: August 25, 2020
• Sponsor: University Hospital, Brest
• Information provided by (Responsible Party): University Hospital, Brest

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
Brain Metastases

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: July 16, 2020
• Actual Primary Completion Date: August 17, 2020
• Actual Study Completion Date: August 17, 2020

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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

Criteria

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

France

CHRU de Brest

Brest, France, 29609

Sponsors and Collaborators

University Hospital, Brest

More Information

• Responsible Party: University Hospital, Brest
• ClinicalTrials.gov Identifier: NCT04525053
• Other Study ID Numbers: SBRT-IRM ( 29BRC20.0156)
• First Posted: August 25, 2020
• Last Update Posted: August 25, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: All collected data that underlie results in a publication.
• Supporting Materials: Study Protocol
• Time Frame: Data will be available beginning 2 months and ending five years following the final study report completion.
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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