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.

NCT ID: NCT06869460

Last Updated: 2025-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

372 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-20

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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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

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Brain Metastases Radiotherapy Side Effect

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with a singular brain metastases

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

Stereotactic Body Radiotherapy/Radiosurgery

Intervention Type RADIATION

Stereotactic Body Radiotherapy/Radiosurgery

Interventions

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Stereotactic Body Radiotherapy/Radiosurgery

Stereotactic Body Radiotherapy/Radiosurgery

Intervention Type RADIATION

Other Intervention Names

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SBRT/SRS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gemelli Molise Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Donato Pezzulla, M.D.

Role: PRINCIPAL_INVESTIGATOR

Responsible Research Hospital

Locations

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Presidio Ospedaliero "S. G. Moscati"

Taranto, Apulia, Italy

Site Status

INT IRCCS Fondazione G. Pascale Napoli

Napoli, Campania, Italy

Site Status

IRCCS Ospedale San Raffaele

Milan, Lombardy, Italy

Site Status

Responsible Research Hospital

Campobasso, Molise, Italy

Site Status

Countries

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Italy

Other Identifiers

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CET20-02-2024

Identifier Type: -

Identifier Source: org_study_id

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