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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00723463
First Posted: July 28, 2008
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Ashok Srinivasan, M.D., University of Michigan
  Purpose
The purpose of this study is to determine normal measurements (ADC values) from the head and neck of healthy volunteers using 3T MRI.

Condition Intervention Phase
Brain Cancer Neck Cancer Procedure: 3T MRI scan Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Retrospective - Prospective - Study to Determine if Apparent Diffusion Coefficient (ADC) Values Can Differentiate Tumors From Normal Tissues at 3T MRI

Further study details as provided by Ashok Srinivasan, M.D., University of Michigan:

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. [ Time Frame: 1 year ]

Enrollment: 200
Study Start Date: June 2006
Study Completion Date: July 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
To determine if apparent diffusion coefficient values can differentiate tumors from normal tissues using a 3T MRI scan.
Procedure: 3T MRI scan
Establishing/evaluating apparent diffusion coefficient (ADC) values using a 3T MRI scan to differentiate tumors from normal tissue.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00723463


Locations
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
National Institutes of Health (NIH)
Investigators
Principal Investigator: Ashok Srinivasan, M.D. University of Michigan
  More Information

Responsible Party: Ashok Srinivasan, M.D., Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT00723463     History of Changes
Other Study ID Numbers: HUM 5527
First Submitted: July 24, 2008
First Posted: July 28, 2008
Last Update Posted: November 2, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases