Clinical trial 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.
Official title: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Brain Metastases
Radiotherapy Side Effect
Keywords: Brain metastases
Radiotherapy
Stereotactic Body Radiotherapy
Radiosurgery
Radionecrosis
Local Control
Safety profile
Radiomics
Lead sponsor: Gemelli Molise Hospital
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 372
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study design concerns all patients diagnosed with brain metastases who underwent stereotactic radiosurgery/radiotherapy between January 2010 and December 2022.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Treatment with SRS/SRT techniques for a single secondary brain lesion
* Availability of pre-RT brain MRI with contrast (1mm slice thickness)
* Availability of CT simulation imaging for treatment
* Availability of relevant clinical data in the medical record for the study's objectives
* Follow-up of at least 6 months after the completion of SRS or SRT
* Follow-up evaluation through brain MRI

Exclusion Criteria:

* Age under 18 years
* Lack of clinical/radiological data for the patient
* Unavailability of the required imaging
* Previous whole-brain radiotherapy treatment

Primary outcomes:
measure: Toxicity profile
timeFrame: due to the retrospective nature of the study, we did not have specific time points.We will evaluate the possible onset of toxicity events from the last day of treatment up to 18 months from the treatment
measure: Local control
timeFrame: We will evaluate Lc at one, two, and five years from the treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: INT IRCCS Fondazione G. Pascale Napoli
state: Campania
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
state: Lombardia
city: Campobasso
country: Italy
facility: Responsible Research Hospital
state: Molise
city: Taranto
country: Italy
facility: Presidio Ospedaliero "S. G. Moscati"
state: Puglia
Study officials:
affiliation: Responsible Research Hospital
name: Donato Pezzulla, M.D.
role: PRINCIPAL_INVESTIGATOR
References: