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

November 1, 2016 updated by: Ashok Srinivasan, M.D., University of Michigan

Retrospective - Prospective - Study to Determine if Apparent Diffusion Coefficient (ADC) Values Can Differentiate Tumors From Normal Tissues at 3T MRI

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Ashok Srinivasan, M.D., University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

July 24, 2008

First Submitted That Met QC Criteria

July 24, 2008

First Posted (Estimate)

July 28, 2008

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM 5527

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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