Investigation Into the Differentiation of Tumour and Heal... | NCT00813787

Studies
Investigation Into the Differentiation of Tumour and Healthy Brain Tissue Using Multi-exponential T2 Components

NCT00813787

Sponsor

AHS Cancer Control Alberta

Status

Unknown status

Last Update Posted

Oct 3, 2014Estimated

Enrollment

20Estimated

Phase

Not provided

Conditions

Glioma

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Apr 2015Estimated

Completion Date

Apr 2015Estimated

First Submitted Date

Dec 19, 2008

First Submission Date that Met QC Criteria

Dec 22, 2008

First Posted Date

Dec 23, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2014

Last Update Posted Date

Oct 3, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to see if a specialized imaging technique using MRI called multi-exponential T2 component analysis can reliably differentiate between normal brain and brain tumour.

Detailed Description

Existing methods of contouring tumours for radiation therapy involve manual interpretations of qualitative diagnostic images. These methods, being qualitative, do not offer a consistent and reproducible platform for contouring, making it difficult to evaluate the effects of contouring choices on treatment outcome. T2 component analysis in MRI has the potential to offer a quantitive basis for identifying tumor tissue- this potential is investigated in this pilot study.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A. glioma		A. glioma population
B. Normal brain		B. Normal brain

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
T2 characteristics of glioma tissue versus normal		Before radiotherapy treatment begins

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Eighteen years of age or older
Clinical subjects must have not yet begun radiation therapy
Must have signed our study-specific consent form

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

A. Any glioma patient who recieves treatment at our clinic (Cross Cancer Institute) who agrees to take part in the study.

B. Any normal volunteer who agrees to take part in the study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Keith Wachowicz, PhD	Contact	(780) 989-4334		keithwac@cancerboard.ab.ca

Overall Officials

Name	Affiliation	Role
Keith Wachowicz, PhD	AHS Cancer Control Alberta	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cross Cancer Institute	Recruiting	Edmonton	Alberta	T6G 1Z2	Canada

Condition Browse Module

MeSH Terms

ID	Term
D005910	Glioma

Ancestor Terms

ID	Term
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided