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

Brain Metastases Clinical Trial

— SBRT-IRM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04525053
• Other study ID #: SBRT-IRM ( 29BRC20.0156)
• Status: Completed
• Start date: July 16, 2020
• Est. completion date: August 17, 2020

Study information

• Verified date: August 2020
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: August 17, 2020
• Est. primary completion date: August 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Metastases
• Neoplasm Metastasis

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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