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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03072979
Recruitment Status : Unknown
Verified March 2017 by Radiation Oncology, National University Hospital, Singapore.
Recruitment status was:  Recruiting
First Posted : March 8, 2017
Last Update Posted : March 8, 2017
National University, Singapore
Information provided by (Responsible Party):
Radiation Oncology, 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

Condition or disease Intervention/treatment
Spine Metastasis Radiation: Stereotactic body radiotherapy

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Study Type : Observational
Estimated 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 : January 21, 2017
Estimated Primary Completion Date : December 31, 2017
Study Completion Date : December 31, 2018

Intervention Details:
  • Radiation: Stereotactic body radiotherapy
    Stereotactic body radiotherapy

Primary Outcome Measures :
  1. Reduction in vasculature [ Time Frame: 3 month ]
    Reduction in vasculature measured by changes on Dynamic Contrast enhanced MRI

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A total of 18 patients from National University Hospital (NUH) will be enrolled. Informed consent will be taken from patients prior to trial entry at NUH.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03072979

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National University Hospital Recruiting
Singapore, Singapore
Sponsors and Collaborators
National University Hospital, Singapore
National University, Singapore
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Responsible Party: Radiation Oncology, Dr Balamurugan Vellayappan, National University Hospital, Singapore Identifier: NCT03072979    
Other Study ID Numbers: 2016/01179
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: March 8, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes