Development of Magnetic Resonance (MR) Simulation for Tre... | NCT00314496

Studies
Development of Magnetic Resonance (MR) Simulation for Treatment Planning

NCT00314496

Sponsor

AHS Cancer Control Alberta

Status

Completed

Last Update Posted

Feb 25, 2016Estimated

Enrollment

10Actual

Phase

Not provided

Conditions

Healthy

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

Jan 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Nov 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Apr 11, 2006

First Submission Date that Met QC Criteria

Apr 13, 2006

First Posted Date

Apr 14, 2006Estimated

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

Feb 24, 2016

Last Update Posted Date

Feb 25, 2016Estimated

Name	Class
Cross Cancer Institute	OTHER

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

Retrospectively have access to MR images of patients to develop software that:

segment images
convert MR values to electron density and then
entered into a dose calculation system

The project involves software development of data that is already available. No intervention is made at this point.

Detailed Description

Not provided

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

10Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject 18 years of age and older

Accepts Healthy Volunteers

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

Adult patient with conform histological diagnosis of glioblastoma multiforme signed the consent forms and were willing to go for curative radiation treatment with temozolomide

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gino Fallone, PhD	AHS Cancer Control Alberta	Principal Investigator

Locations

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