Evaluation of Effectiveness of CyberKnife Stereotactic Radiosurgery for Spinal Tumors

NCT ID: NCT04192383

Last Updated: 2021-06-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2022-01-01

Brief Summary

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 .

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.

Conditions

Spinal Neoplasms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cyberknife

Cyberknife stereotactic radiosurgery

Intervention Type: RADIATION

Hypofractionated stereotactic radiosurgery

Interventions

Cyberknife stereotactic radiosurgery

Hypofractionated stereotactic radiosurgery

Intervention Type: RADIATION

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yongye Chen

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Yongye Chen, MS

Role: primary

chenyongye1995@163.com

13426194125 ext. 13426194125

Other Identifiers

IRB00006761-M2018251

Identifier Type: -

Identifier Source: org_study_id