Stereotactic Radiosurgery Prognosis Assessment for Spinal Tumors Based on Radiomics

Prognosis Clinical Trial

Official title:

Stereotactic Radiosurgery Prognosis Assessment for Spinal Tumors Based on Radiomics

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05369689
• Other study ID #: SBRTradiomics
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Prognosis
• Radiomics
• Spinal Cord Neoplasms
• Spinal Neoplasms
• Spinal Tumor

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