Evaluation of Effectiveness of CyberKnife Stereotactic Radiosurgery for Spinal Tumors

June 27, 2021 updated by: Peking University Third Hospital

Functional Magnetic Resonance Imaging Combined With Radiomics for Evaluation of Effectiveness of CyberKnife Stereotactic Radiosurgery for Spinal Tumors

This study aims to explore the reliability of the combination of functional magnetic resonance imaging and radiomics for evaluation of the therapeutic efficacy of CyberKnife stereotactic radiosurgery for spinal tumors. Accurate imaging assessment can help clinicians plan personalized therapeutic schedules for patients with spinal tumors .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Spinal tumors may be metastases or primary tumors; the former are more common. About 40% of cancer patients will have spinal metastasis. Primary spinal tumor is relatively rare, accounting for only about 8% of spinal tumors. For both metastasis and primary tumor, the aim of treatment is to reduce pain, maintain or improve neurological function, and maintain or restore spinal stability.

In patients who cannot undergo surgery or need additional treatment after surgery, radiation therapy can relieve pain, prolong survival, improve the success rate of surgery, and reduce risk of metastasis and recurrence. However, the complex anatomy of the spine, and the numerous important organs around it, makes radiation treatment challenging. High-dose radiation therapy is necessary for long-term control of the tumor and for prevention of spinal column instability; however, this is impossible with traditional radiotherapy due to the presence of the radiosensitive spinal cord. Outcomes therefore tend to be poor for large and complex lesions. The CyberKnife-a stereotactic body radiation therapy (SBRT) platform that combines a lightweight linear accelerator, a robotic arm, an imaging system, and a respiratory tracking system-offers a feasible approach. It can achieve submillimeter level-precision treatment under imaging guidance.

Currently, the effectiveness of CyberKnife radiosurgery for spinal tumors is decided by assessing imaging changes, relief of clinical symptoms, and needle biopsy, but all of these methods have limitations. On imaging, for example, change in lesion volume is used to assess tumor regression, but the size of a spinal tumor is not easy to measure and, moreover, decrease in tumor volume after treatment may take time . Post-treatment signal intensity changes in conventional magnetic resonance imaging (MRI) T1-weighted and T2-weighted sequences are difficult to interpret, and their relationship with treatment efficacy is also not clear.

Generally speaking, alterations in microscopic structure and biological activity of the tumor occur much earlier than changes in gross morphology . Functional magnetic resonance imaging (fMRI) can therefore be more useful than conventional MRI for assessing treatment response. In fMRI, sequences such as diffusion-weighted imaging (DWI), dynamic contrast-enhanced MRI (DCE-MRI), and diffusion kurtosis imaging (DKI) reflect functional information of tissues from different perspectives.

Application of artificial intelligence technology for analysis of medical imaging data is now an area of intense research. This new method, which is called radiomics, can help in solving many difficult clinical problems. By extracting a large number of highly representative quantitative imaging features from high-throughput medical image data, radiomics can help in evaluating treatment efficacy and predicting prognosis of spinal tumors.

Investigators intend to explore the use of the combination of fMRI and radiomics for evaluating the effectiveness of CyberKnife radiosurgery for spinal tumors. The method will be able to evaluate both volume and functional changes in the tumor, and thus provide important information for planning of individualized therapeutic schedules for patients with spinal tumors.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

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

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Yongye Chen
        • Contact:

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cohorts will be selected form Peking University Third Hospital.

Description

Inclusion criteria:

  • Biopsy-proven spinal or paraspinal metastases;
  • MRI and DCE-MRI examination performed before and at 3 months after CyberKnife treatment.

Exclusion criteria:

  • Area of the lesion surgically removed before enrollment;
  • Prior percutaneous vertebroplasty or kyphoplasty or radiation therapy of the target lesion;
  • Chemotherapy within a month;
  • Unable to cooperate with-or refusal of-CT, conventional MRI, or DCE-MRI examination;
  • Lost to follow-up;
  • Poor image quality that cannot be analyzed.

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
Cyberknife
Radiation: Cyberknife stereotactic radiosurgery
Hypofractionated stereotactic radiosurgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival(OS)
Time Frame: From the start of randomization to the date of death of the patient or the end of the study (at 60 months).
The time from the start of treatment to the date of death or last follow-up
From the start of randomization to the date of death of the patient or the end of the study (at 60 months).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival(PFS)
Time Frame: From the start of randomization to the first evidence of tumor progression or death of the patient or the end of the study (at 60 months), whichever occurs first.
The time from the start of treatment to the date of diagnosis of tumor progression or death. Tumor progression is defined as increase in lesion volume on MRI compared to baseline, or identification of new metastasis on imaging or histological examination.
From the start of randomization to the first evidence of tumor progression or death of the patient or the end of the study (at 60 months), whichever occurs first.
Numerical rating scales (NRS)
Time Frame: Measurements will be performed every 3 months, starting from randomization until the patient's death or till end of the study (at 60 months ).
A 11 point scale where the end points are the extremes of no pain and pain as bad as it could be, or worst pain.
Measurements will be performed every 3 months, starting from randomization until the patient's death or till end of the study (at 60 months ).
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Time Frame: Measurements will be performed every 3 months, starting from randomization until the patient's death or till end of the study (at 60 months ).
The QLQ-C30 is a cancer-specific, self-administered, structured questionnaire designed for use in clinical trials, which contains 30 questions (items),
Measurements will be performed every 3 months, starting from randomization until the patient's death or till end of the study (at 60 months ).

Collaborators and Investigators

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

Sponsor

Peking University Third Hospital

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 (ACTUAL)

September 1, 2018

Primary Completion (ACTUAL)

June 1, 2021

Study Completion (ANTICIPATED)

January 1, 2022

Study Registration Dates

First Submitted

December 5, 2019

First Submitted That Met QC Criteria

December 8, 2019

First Posted (ACTUAL)

December 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 29, 2021

Last Update Submitted That Met QC Criteria

June 27, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00006761-M2018251

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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