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

Sponsor
National University Hospital, Singapore (Other)
Overall Status
Unknown status
CT.gov ID
NCT03072979
Collaborator
National University, Singapore (Other)
18
Enrollment
1
Location
23.3
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Radiation: Stereotactic body radiotherapy

Study Design

Study Type:
Observational
Anticipated Enrollment :
18 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Reduction in Tumour Perfusion for Spine Metastasis Treated With Stereotactic Body Radiotherapy (SBRT)
Actual Study Start Date :
Jan 21, 2017
Anticipated Primary Completion Date :
Dec 31, 2017
Study Completion Date :
Dec 31, 2018

Outcome Measures

Primary Outcome Measures

  1. Reduction in vasculature [3 month]

    Reduction in vasculature measured by changes on Dynamic Contrast enhanced MRI

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National University Hospital Singapore Singapore

Sponsors and Collaborators

  • National University Hospital, Singapore
  • National University, Singapore

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Radiation Oncology, Dr Balamurugan Vellayappan, National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT03072979
Other Study ID Numbers:
  • 2016/01179
First Posted:
Mar 8, 2017
Last Update Posted:
Mar 8, 2017
Last Verified:
Mar 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasm Metastasis

Study Results

No Results Posted as of Mar 8, 2017