Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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 30, 2016
Last verified: March 2016
  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: 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:


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 2016
Estimated 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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
  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 
Study First Received: July 24, 2008
Last Updated: March 30, 2016
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 23, 2016