Back to resultsDetermine if Apparent Diffusion Coefficient (ADC) Values Can Differentiate Tumors From Normal Tissue
Primary Purpose
Brain Cancer, Neck Cancer
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
3T MRI scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Brain Cancer
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.
Sites / Locations
- University of Michigan Health System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
To determine if apparent diffusion coefficient values can differentiate tumors from normal tissues using a 3T MRI scan.
Outcomes
Primary Outcome Measures
To determine if ADC values determined at 3T are different between normal tissues and tumors arising from the extracranial head and neck.
Secondary Outcome Measures
Full Information
NCT ID
NCT00723463
First Posted
July 24, 2008
Last Updated
November 1, 2016
Sponsor
University of Michigan
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT00723463
Brief Title
Determine if Apparent Diffusion Coefficient (ADC) Values Can Differentiate Tumors From Normal Tissue
Official Title
Retrospective - Prospective - Study to Determine if Apparent Diffusion Coefficient (ADC) Values Can Differentiate Tumors From Normal Tissues at 3T MRI
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institutes of Health (NIH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Cancer, Neck Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
To determine if apparent diffusion coefficient values can differentiate tumors from normal tissues using a 3T MRI scan.
Intervention Type
Procedure
Intervention Name(s)
3T MRI scan
Intervention Description
Establishing/evaluating apparent diffusion coefficient (ADC) values using a 3T MRI scan to differentiate tumors from normal tissue.
Primary Outcome Measure Information:
Title
To determine if ADC values determined at 3T are different between normal tissues and tumors arising from the extracranial head and neck.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashok Srinivasan, M.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Determine if Apparent Diffusion Coefficient (ADC) Values Can Differentiate Tumors From Normal Tissue
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