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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Ashok Srinivasan, M.D., University of Michigan
ClinicalTrials.gov Identifier:
NCT00723463
First received: July 24, 2008
Last updated: March 5, 2013
Last verified: March 2013
History of Changes
  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
 Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: June 2006
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (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.
 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Health System
  More Information

No publications provided

Responsible Party: Ashok Srinivasan, M.D., Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT00723463     History of Changes
Other Study ID Numbers: HUM 5527
Study First Received: July 24, 2008
Last Updated: March 5, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013