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

Brain Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723463
• Other study ID #: HUM 5527
• Status: Completed
• Phase: Phase 0
• First received: July 24, 2008
• Last updated: November 1, 2016
• Start date: June 2006
• Est. completion date: July 2016

Study information

• Verified date: November 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Brain Cancer
• Brain Neoplasms
• Neck Cancer

Intervention

Procedure:
• 3T MRI scan
Establishing/evaluating apparent diffusion coefficient (ADC) values using a 3T MRI scan to differentiate tumors from normal tissue.

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine if ADC values determined at 3T are different between normal tissues and tumors arising from the extracranial head and neck.		1 year	No