Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: 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.

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Presidio Ospedaliero "S. G. Moscati", Taranto, Apulia, Italy

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stereotactic Body Radiotherapy/Radiosurgery

Radiation

Stereotactic Body Radiotherapy/Radiosurgery

Other names: SBRT/SRS

Primary outcomes

  1. Toxicity profile

    Time frame: 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

    "The toxicity profile of the treatment will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute."

  2. Local control

    Time frame: We will evaluate Lc at one, two, and five years from the treatment

    It 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

Sponsors and collaborators

Lead sponsor

Gemelli Molise Hospital

Other

Registry information

Official study 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

Acronym: STEREOMIC

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 11, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.