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Not yet recruiting NCT05369689

Stereotactic Radiosurgery Prognosis Assessment for Spinal Tumors Based on Radiomics

Observational Stereotactic Radiosurgery Spinal Tumor Radiomics Prognosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No interventions.
Who it may be relevant to
Registry conditions: Stereotactic Radiosurgery, Spinal Tumor, Radiomics, Prognosis. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This study aims to assess multimodal Radiomics-based prediction model for prognostic prediction in spinal tumors.

Detailed description

Sensitivity for prediction recurrence and survival of currently available prognostic scores is limited. This study proposes to establish a multimodal radiomics model for identifying tumor recurrence and prognostic prediction of spinal tumors. The study will investigate the relationship between the radiomics and the tumor microenvironment. The study includes the construction of multimodal radiomics-based prediction model and the validation of the prediction model.

Interventions

  • Other No interventions
    As this is a prognosis evaluation study, there are no interventions.

Primary outcome measures

  • PFS [Time frame: 1 years]
Secondary outcome measures (4)
  • Overall survival (OS) [Time frame: 1 years]
  • ORR [Time frame: 3 months]
  • DCR [Time frame: 3 months]
  • Recurrence free survival (RFS) [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

A diagnosis of spinal tumors for which SBRT is appropriate Karnofsky Performance Status >60 Life expectancy of at least 3 months No contraindication to undergoing MR imaging Age >18 Complete the CT MRI or PET-CT examination before and after treatment Accept stereotactic radiosurgery

Exclusion criteria

Subjects unable to undergo MRI (includes non-MRI compatible material or devices and severe claustrophobia) Subjects with prior procedural intervention to the involved vertebral body that would result in artifact (kyphoplasty, screw and/or rod placement); minimally invasive surgery without instrumentation of the involved vertebral body and instrumentation immediately above or below the index lesion is allowed.

Subjects with spinal cord compression; minimally invasive "separation" surgery to first resect the epidural component is allowed Pregnant or breast-feeding women Allergy to standard IV contrast agents used in MRI

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Department of Radiation Oncology Cancer Center, Peking University Third Hospital 49# North — Beijing

Identifiers

NCT: NCT05369689 · SBRTradiomics

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗