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

NCT ID: NCT03072979

Last Updated: 2017-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-21

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spine Metastasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Stereotactic body radiotherapy

Stereotactic body radiotherapy

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National University of Singapore

OTHER

Sponsor Role collaborator

National University Hospital, Singapore

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Radiation Oncology

Dr Balamurugan Vellayappan

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National University Hospital

Singapore, , Singapore

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Singapore

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

BALAMURUGAN VELLAYAPPAN, MBBS, FRANZCR

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

BALAMURUGAN VELLAYAPPAN

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2016/01179

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Spinal met_radiosurgery/SBRT Study
NCT01231061 COMPLETED PHASE2