NCT06869460

Multicenter Retrospective Study on Patients Treated with Stereotactic Radiosurgery/Radiotherapy for Single Brain Lesions: Evaluation of Treatment Efficacy and Safety, Also Through Radiomic Analysis Methods.

STEREOMIC: Studio Retrospettivo Multicentrico Su Pazienti Trattati Con Radiochirurgia/Radioterapia STEREotassica Per Lesioni Encefaliche Singole. Valutazione Di Efficacy E Safety Del Trattamento Anche Mediante Metodiche Di Analisi RadiOMICa

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 372 (estimated)
• Sponsor: Gemelli Molise Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study design concerns all patients diagnosed witha singular brain metastasis who underwent stereotactic radiosurgery/radiotherapy between January 2010 and December 2022

Detailed description

The study will include patients of both sexes diagnosed with single brain metastases who underwent radiosurgical/stereotactic treatment. Attention will be paid to data related to local control, potential recurrence, and/or radionecrosis. Once a sufficient number of treated patients is reached, the feasibility of a radiomic feature analysis will be assessed in order to identify potential correlations and/or predictive values for treatment response or radionecrosis. If the sample size is adequate, participating centers will be asked to share pre- and post-RT MRI (brain MRI with contrast using thin slices) and treatment volumes for radiomic evaluation.

Conditions

• Brain Metastases
• Radiotherapy Side Effect

Interventions

Type	Name	Description
RADIATION	Stereotactic Body Radiotherapy/Radiosurgery	Stereotactic Body Radiotherapy/Radiosurgery

Timeline

• Start date: 2024-02-20
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2025-03-11
• Last updated: 2025-03-11

Locations

4 sites across 1 country: Italy