NCT01191346

Brief Summary

The purpose of this research study is to see if a higher strength MRI procedure provides better images to use in planning radiation treatments for patients with brain tumors in the future.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2010

Typical duration for all trials

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, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 30, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

August 22, 2017

Status Verified

December 1, 2014

Enrollment Period

2.8 years

First QC Date

August 25, 2010

Last Update Submit

August 21, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Treatment volume

    To assess the difference in treatment volume for radiation planning in gliomas as calculated using 1.5T versus 3T magnets

    1 year average

Study Arms (1)

3T MRI

Patients receiving 3T MRI

Other: 3T MRI

Interventions

3T MRIOTHER

3T MRI in addition to standard 1.5T MRI for treatment planning

3T MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with high grade glioma planning to receive radiation therapy

You may qualify if:

  • Histologically confirmed, newly diagnosed Grade III-IV glioma
  • Planning to undergo radiation therapy

You may not qualify if:

  • Grade I or II glioma
  • Patients unable to undergo MRI imaging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Jessica Guarnaschelli, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Clinical Trials

Study Record Dates

First Submitted

August 25, 2010

First Posted

August 30, 2010

Study Start

June 1, 2010

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

August 22, 2017

Record last verified: 2014-12

Data Sharing

IPD Sharing
Will not share

Locations