A Study to Quantify Tumour Perfusion for Spine Metastasis Treated With Stereotactic Body Radiotherapy (SBRT)

• Conditions: Spine Metastasis

• Registration Number: NCT03072979
• Lead Sponsor: National University Hospital, Singapore

Brief Summary

Pre-clinical evidence suggests that radiotherapy reduces tumour-associated vasculature. The investigators will conduct a single-arm prospective study to quantify the reduction in tumour vasculature post-radiotherapy

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-21
• Study First Submitted: 2017-02-28
• Status Verified: 2017-03
• Study First Submitted QC: 2017-03-02
• Last Update Submitted: 2017-03-02
• Study First Posted: 2017-03-08
• Last Update Posted: 2017-03-08
• Primary Completion: 2017-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Age ≥21 years of age
• Proven metastatic disease, excluding haematological and germ cell neoplasms
• Life expectancy >3 months, Eastern Cooperative Oncology group (ECOG) 0-2

Exclusion Criteria

• The patient must not have an allergy to gadolinium contrast that will limit the ability to image the tumour by MRI safely even with the use of premedication
• eGFR < 30 mL/min or if patient is suffering from acute renal insufficiency
• Prior radiotherapy to the specified region
• Recent surgery to affected spinal levels, or patients requiring immediate surgical intervention
• Spinal instability score (SINS) >12
• Symptomatic cord compression (Bilksy grade 2 or 3), or worsening neurological deficits
• Body weight of more than 120kg
• Pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in vasculature	3 month	Reduction in vasculature measured by changes on Dynamic Contrast enhanced MRI

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore