NCT03072979

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 28, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 8, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

March 8, 2017

Status Verified

March 1, 2017

Enrollment Period

11 months

First QC Date

February 28, 2017

Last Update Submit

March 2, 2017

Conditions

Spine Metastasis

Outcome Measures

Primary Outcomes (1)

  • Reduction in vasculature

    Reduction in vasculature measured by changes on Dynamic Contrast enhanced MRI

    3 month

Interventions

Stereotactic body radiotherapyRADIATION

Stereotactic body radiotherapy

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

BALAMURUGAN VELLAYAPPAN, MBBS, FRANZCR

CONTACT

67795555bala_vellayappan@nuhs.edu.sg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Balamurugan Vellayappan

Study Record Dates

First Submitted

February 28, 2017

First Posted

March 8, 2017

Study Start

January 21, 2017

Primary Completion

December 31, 2017

Study Completion

December 31, 2018

Last Updated

March 8, 2017

Record last verified: 2017-03

Locations

SG(1)