Spine MetastasisNCT03072979
A Study to Quantify Tumour Perfusion for Spine Metastasis Treated With Stereotactic Body Radiotherapy (SBRT)
An observational study of Spine Metastasis, run by National University Hospital, Singapore at 1 site in Singapore.
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 Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Spine Metastasis
- What is being tested?
- Stereotactic body radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 18 participants
- Where
- 1 siteSingapore
- Study dates
- 21 Jan 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore
BALAMURUGAN VELLAYAPPAN, bala_vellayappan@nuhs.edu.sg
About this study
Official title: Reduction in Tumour Perfusion for Spine Metastasis Treated With Stereotactic Body Radiotherapy (SBRT)
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
- Conditions
- Spine Metastasis
- Being tested
- Stereotactic body radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic body radiotherapyRadiation
Stereotactic body radiotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in vasculature
Reduction in vasculature measured by changes on Dynamic Contrast enhanced MRI
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start21 Jan 2017
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine MetastasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore
- Responsible party
- Principal investigator, Radiation Oncology, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072979
- Sponsor's protocol ID
- 2016/01179
- Other IDs
- 2016
- Status last verified
- Mar 2017
- First submitted
- 28 Feb 2017
- Last updated
- 8 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction in Tumour Perfusion for Spine Metastasis Treated With Stereotactic Body Radiotherapy (SBRT)
- ClinicalTrials.gov ID
- NCT03072979
- Acronym / sponsor ID
- 2016/01179
- Conditions
- Spine Metastasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National University of Singapore
- Study start
- 21 Jan 2017 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2018
- First posted
- 8 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic body radiotherapyStereotactic body radiotherapy | Radiation | – |
Primary outcome
Reduction in vasculature
Time frame: 3 month
Reduction in vasculature measured by changes on Dynamic Contrast enhanced MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spine Metastasis, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BALAMURUGAN VELLAYAPPAN, MBBS, FRANZCR (67795555, bala_vellayappan@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in vasculature (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2017.