NCT00723463

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jun 2006

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2008

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

10 years

First QC Date

July 24, 2008

Last Update Submit

November 1, 2016

Conditions

Brain CancerNeck Cancer

Outcome Measures

Primary Outcomes (1)

  • To determine if ADC values determined at 3T are different between normal tissues and tumors arising from the extracranial head and neck.

    1 year

Study Arms (1)

A

EXPERIMENTAL

To determine if apparent diffusion coefficient values can differentiate tumors from normal tissues using a 3T MRI scan.

Procedure: 3T MRI scan

Interventions

3T MRI scanPROCEDURE

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

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subjects 18 years of age or older.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Brain NeoplasmsHead and Neck Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Ashok Srinivasan, M.D.

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 24, 2008

First Posted

July 28, 2008

Study Start

June 1, 2006

Primary Completion

June 1, 2016

Study Completion

July 1, 2016

Last Updated

November 2, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)