Determine if Apparent Diffusion Coefficient (ADC) Values... | NCT00723463

Studies
Determine if Apparent Diffusion Coefficient (ADC) Values Can Differentiate Tumors From Normal Tissue

NCT00723463

Sponsor

University of Michigan

Status

Completed

Last Update Posted

Nov 2, 2016Estimated

Enrollment

200Actual

Phase

Early Phase 1

Conditions

Brain Cancer
Neck Cancer

Interventions

3T MRI scan

Countries

United States

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

Nov 2016

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

Jun 2006

Primary Completion Date

Jun 2016Actual

Completion Date

Jul 2016Actual

First Submitted Date

Jul 24, 2008

First Submission Date that Met QC Criteria

Jul 24, 2008

First Posted Date

Jul 28, 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

Nov 1, 2016

Last Update Posted Date

Nov 2, 2016Estimated

Name	Class
National Institutes of Health (NIH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

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 determine normal measurements (ADC values) from the head and neck of healthy volunteers using 3T MRI.

Detailed Description

The purpose of this study is to determine normal measurements (ADC values) from the head and necks of healthy subjects using 3T MRI.

Design Module

Study Type

Interventional

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	To determine if apparent diffusion coefficient values can differentiate tumors from normal tissues using a 3T MRI scan.	Procedure: 3T MRI scan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
3T MRI scan	Procedure	Establishing/evaluating apparent diffusion coefficient (ADC) values using a 3T MRI scan to differentiate tumors from normal tissue.	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine if ADC values determined at 3T are different between normal tissues and tumors arising from the extracranial head and neck.		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy subjects 18 years of age or older.

Exclusion Criteria:

Under 18 years of age
Women of child bearing potential
Pregnant or lactating women
All potential volunteers will be pre-screened by MRI personnel to determine if there is any medical reason that you should not be included in this study.

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ashok Srinivasan, M.D.	University of Michigan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Michigan Health System		Ann Arbor	Michigan	48109	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001932	Brain Neoplasms
D006258	Head and Neck Neoplasms

Ancestor Terms

ID	Term
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided