Stereotactic Radiosurgery Prognosis Assessment for Spinal Tumors Based on Radiomics

May 7, 2022 updated by: Zhuang Hongqing
This study aims to assess multimodal Radiomics-based prediction model for prognostic prediction in spinal tumors.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Department of Radiation Oncology Cancer Center, Peking University Third Hospital 49# North Garden Rd.,Haidian Dist.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 1 years
progression-free survival
1 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: 3 months
objective response rate
3 months
Overall survival (OS)
Time Frame: 1 years
defined as the time from the beginning of diagnosis of spinal tumors to the death with any causes
1 years
DCR
Time Frame: 3 months
disease control rate
3 months
Recurrence free survival (RFS)
Time Frame: 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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhuang Hongqing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

June 1, 2027

Study Registration Dates

First Submitted

May 7, 2022

First Submitted That Met QC Criteria

May 7, 2022

First Posted (Actual)

May 11, 2022

Study Record Updates

Last Update Posted (Actual)

May 11, 2022

Last Update Submitted That Met QC Criteria

May 7, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBRTradiomics

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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