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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06869460
Acronym
STEREOMIC
Enrollment
372
Registered
2025-03-11
Start date
2024-02-20
Completion date
2025-12-31
Last updated
2025-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Metastases, Radiotherapy Side Effect

Keywords

Brain metastases, Radiotherapy, Stereotactic Body Radiotherapy, Radiosurgery, Radionecrosis, Local Control, Safety profile, Radiomics

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.

Interventions

RADIATIONStereotactic Body Radiotherapy/Radiosurgery

Stereotactic Body Radiotherapy/Radiosurgery

Sponsors

Gemelli Molise Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Toxicity profiledue 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 treatmentThe toxicity profile of the treatment will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute.
Local controlWe will evaluate Lc at one, two, and five years from the treatmentIt will be Calculated 'per lesion,' and it is defined as the time interval between irradiation and the onset of disease recurrence at the site of the treated area

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026