## Protocol Section
### Identification Module
**NCT ID:** NCT03072979

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

**Official Title:** Reduction in Tumour Perfusion for Spine Metastasis Treated With Stereotactic Body Radiotherapy (SBRT)

#### Organization Study ID Info
**ID:** 2016/01179
#### Organization
**Class:** OTHER
**Full Name:** National University Hospital, Singapore
### Status Module
#### Completion Date
**Date:** 2018-12-31

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2017-03-08

**Type:** ACTUAL

**Last Update Submit Date:** 2017-03-02

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2017-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2017-01-21

**Type:** ACTUAL

**Status Verified Date:** 2017-03

#### Study First Post Date
**Date:** 2017-03-08
**Type:** ACTUAL
**Study First Submit Date:** 2017-02-28
**Study First Submit QC Date:** 2017-03-02
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** National University of Singapore

#### Lead Sponsor

**Class:** OTHER

**Name:** National University Hospital, Singapore

#### Responsible Party

**Investigator Affiliation:** National University Hospital, Singapore

**Investigator Full Name:** Radiation Oncology

**Investigator Title:** Dr Balamurugan Vellayappan

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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

### Conditions Module

**Conditions:**

- Spine Metastasis

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 18

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** Stereotactic body radiotherapy

**Name:** Stereotactic body radiotherapy

**Type:** RADIATION

### Outcomes Module

#### Primary Outcomes

**Description:** Reduction in vasculature measured by changes on Dynamic Contrast enhanced MRI

**Measure:** Reduction in vasculature

**Time Frame:** 3 month

### Eligibility Module

**Eligibility Criteria:** 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 Age:** 21 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** bala_vellayappan@nuhs.edu.sg

**Name:** BALAMURUGAN VELLAYAPPAN, MBBS, FRANZCR

**Phone:** 67795555

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Singapore

**Contacts:**

***Contact 1:***

- **Email:** bala_vellayappan@nuhs.edu.sg

- **Name:** BALAMURUGAN VELLAYAPPAN

- **Role:** CONTACT

**Country:** Singapore

**Facility:** National University Hospital

**Status:** RECRUITING

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009385

- Term: Neoplastic Processes

- ID: D000009369

- Term: Neoplasms

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12307

- Name: Neoplasm Metastasis

- Relevance: HIGH

- As Found: Metastases

- ID: M12330

- Name: Neoplastic Processes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009362

- Term: Neoplasm Metastasis

### Misc Info Module

- Version Holder: 2024-05-24
