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

Spine Metastasis Clinical Trial

Official title:

Reduction in Tumour Perfusion for Spine Metastasis Treated With Stereotactic Body Radiotherapy (SBRT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03072979
• Other study ID #: 2016/01179
• Status: Recruiting
• Phase: N/A
• First received: February 28, 2017
• Last updated: March 2, 2017
• Start date: January 21, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2017
• Source: National University Hospital, Singapore
• Contact: BALAMURUGAN VELLAYAPPAN, MBBS, FRANZCR
• Phone: 67795555
• Email: bala_vellayappan[@]nuhs.edu.sg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Spine Metastasis

Intervention

Radiation:
• Stereotactic body radiotherapy
Stereotactic body radiotherapy

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University Hospital, Singapore	National University, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in vasculature	Reduction in vasculature measured by changes on Dynamic Contrast enhanced MRI	3 month