Stereotactic Radiosurgery Prognosis Assessment for Spinal Tumors Based on Radiomics

Sponsor
Zhuang Hongqing (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05369689
Collaborator
(none)
300
1
60
5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: No interventions

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Stereotactic Radiosurgery Prognosis Assessment for Spinal Tumors Based on Radiomics
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Jun 1, 2027

Arms and Interventions

Arm Intervention/Treatment
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
As this is a prognosis evaluation study, there are no interventions.

Outcome Measures

Primary Outcome Measures

  1. PFS [1 years]

    progression-free survival

Secondary Outcome Measures

  1. Overall survival (OS) [1 years]

    defined as the time from the beginning of diagnosis of spinal tumors to the death with any causes

  2. ORR [3 months]

    objective response rate

  3. DCR [3 months]

    disease control rate

  4. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Radiation Oncology Cancer Center, Peking University Third Hospital 49# North Garden Rd.,Haidian Dist. Beijing Beijing China 100191

Sponsors and Collaborators

  • Zhuang Hongqing

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhuang Hongqing, Associate department chairman of radiotherapy, Peking University Third Hospital
ClinicalTrials.gov Identifier:
NCT05369689
Other Study ID Numbers:
  • SBRTradiomics
First Posted:
May 11, 2022
Last Update Posted:
May 11, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 11, 2022