Stereotactic Radiosurgery Prognosis Assessment for Spinal Tumors Based on Radiomics

Not yet recruiting

• Conditions: Prognosis; Stereotactic Radiosurgery; Radiomics; Spinal Tumor
• Interventions: Other: No interventions

• Registration Number: NCT05369689
• Lead Sponsor: Zhuang Hongqing

Brief Summary

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.

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-07
• Study First Submitted QC: 2022-05-07
• Last Update Submitted: 2022-05-07
• Study First Posted: 2022-05-11
• Last Update Posted: 2022-05-11
• Study Start: 2022-06-01
• Primary Completion: 2022-12-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
spinal tumors, CT, MRI, PET-CT stereotactic radiosurgery	No interventions	Patients who had spinal tumors and completed the CT, MRI or PET-CT examination before and after stereotactic radiosurgery.

Primary Outcome Measures

Name	Time	Method
PFS	1 years	progression-free survival

Secondary Outcome Measures

Name	Time	Method
ORR	3 months	objective response rate
Recurrence free survival (RFS)	1 year	defined as time between randomization and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred
Overall survival (OS)	1 years	defined as the time from the beginning of diagnosis of spinal tumors to the death with any causes
DCR	3 months	disease control rate

Trial Locations

Locations (1)

Department of Radiation Oncology Cancer Center, Peking University Third Hospital 49# North Garden Rd.,Haidian Dist.; 🇨🇳 Beijing, Beijing, China