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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05369689
Other study ID # SBRTradiomics
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2022
Est. completion date June 1, 2027

Study information

Verified date May 2022
Source Peking University Third Hospital
Contact Hongqing zhuang
Phone 82264910
Email hongqingzhuang@163.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date June 1, 2027
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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


Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Zhuang Hongqing

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary PFS progression-free survival 1 years
Secondary Overall survival (OS) defined as the time from the beginning of diagnosis of spinal tumors to the death with any causes 1 years
Secondary ORR objective response rate 3 months
Secondary DCR disease control rate 3 months
Secondary Recurrence free survival (RFS) 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
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