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NCT Number: NCT05369689

Stereotactic Radiosurgery Prognosis Assessment for Spinal Tumors Based on Radiomics

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Beijing, Beijing Municipality, 100191, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No interventions

Other

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

Primary outcomes

  1. PFS

    Time frame: 1 years

    progression-free survival

Secondary outcomes

  1. 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

  2. ORR

    Time frame: 3 months

    objective response rate

  3. DCR

    Time frame: 3 months

    disease control rate

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Hongqing zhuang

CONTACT

[email protected]

82264910

Mingqing Wang

CONTACT

[email protected]

82264917

Sponsors and collaborators

Lead sponsor

Zhuang Hongqing

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2027
First posted
May 11, 2022
Registry last updated
May 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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