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Clinical Trial Finder

Search Results

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.

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06869460
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Gemelli Molise Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Donato Pezzulla, M.D.
Principal Investigator Affiliation Responsible Research Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Active, not recruiting
Countries Italy
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain Metastases, Radiotherapy Side Effect
Additional Details

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.

Arms & Interventions

Arms

: 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

Interventions

Radiation: - Stereotactic Body Radiotherapy/Radiosurgery

Stereotactic Body Radiotherapy/Radiosurgery

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

INT IRCCS Fondazione G. Pascale Napoli, Napoli, Campania, Italy

Status

Address

INT IRCCS Fondazione G. Pascale Napoli

Napoli, Campania,

IRCCS Ospedale San Raffaele, Milano, Lombardia, Italy

Status

Address

IRCCS Ospedale San Raffaele

Milano, Lombardia,

Responsible Research Hospital, Campobasso, Molise, Italy

Status

Address

Responsible Research Hospital

Campobasso, Molise, 80017

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

Status

Address

Presidio Ospedaliero "S. G. Moscati"

Taranto, Puglia,

Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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