Stereotactic Radiosurgery Prognosis Assessment for Spinal Tumors Based on Radiomics

NCT05369689 | Not Yet Recruiting DMC

• 1 other identifier: SBRTradiomics
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stereotactic Radiosurgery; Spinal Tumor; Radiomics; Prognosis

Outcome Measures

Primary Outcomes (1)

• PFS

  progression-free survival

  1 years

Secondary Outcomes (4)

• Overall survival (OS)

  1 years

• ORR

  3 months

• DCR

  3 months

• Recurrence free survival (RFS)

  1 year

Study Arms (1)

spinal tumors, CT, MRI, PET-CT stereotactic radiosurgery

Patients who had spinal tumors and completed the CT, MRI or PET-CT examination before and after stereotactic radiosurgery.

Other: No interventions

Interventions

No interventions OTHER

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

spinal tumors, CT, MRI, PET-CT stereotactic radiosurgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who had spinal tumors and completed CT, MRI, PET-CT examination before and after stereotactic radiosurgery.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhuang Hongqing: lead

Study Sites (1)

Department of Radiation Oncology Cancer Center, Peking University Third Hospital 49# North Garden Rd.,Haidian Dist.

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Spinal Cord Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Hongqing zhuang

CONTACT

82264910; hongqingzhuang@163.com

Mingqing Wang

CONTACT

82264917; wangronggang.love@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate department chairman of radiotherapy

Study Record Dates

• First Submitted: May 7, 2022
• First Posted: May 11, 2022
• Study Start: June 1, 2022
• Primary Completion: December 1, 2022
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)