- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02340715
Advanced MRI Sequences for Radiation Therapy Treatment Planning
October 30, 2017 updated by: AhunbayE, Medical College of Wisconsin
Investigation on the Utility of Advanced MRI Imaging Methods for Radiation Therapy Treatment Planning
The purpose of this study is to determine if it would be helpful to use advanced MRI imaging techniques to take additional views of the tumor target for radiation treatment planning or treatment follow-up MRI.
Study Overview
Status
Completed
Conditions
Detailed Description
The results of this research project will be used to establish a standard MRI protocol specific to each tumor or disease site.
An MRI protocol is a list of MR image types that are acquired for each disease site.
These images are used to generate the patient's treatment plan.
Study Type
Observational
Enrollment (Actual)
158
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
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Froedtert Hospital
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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 to 89 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Subjects who are planning to have radiation therapy for their cancer.
Description
Inclusion Criteria:
- Patients aged 18 years older of any race or gender with anal canal, brain, breast, cervix, esophagus, gynecology, head and neck, lung, pancreas, primary liver or liver metastases, prostate cancer or sarcoma either undergoing MRI scan for radiation treatment planning or a post treatment MRI
- Voluntarily signs an IRB approved consent form
Exclusion Criteria:
- Inability to obtain informed consent from the patient or their medical power of attorney
- Patients who are not undergoing MR for radiation treatment planning
- Patients who will not have MRI scans after treatment
- Patients with pacemakers or other non-MRI compatible metallic implants
- Pregnant women, by self report using a standard MRI questionnaire
- Patients who will not receive contrast agent as part of their standard MR, will participate only in the non-contrast portion of the 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
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
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MRI for treatment planning or follow up
MRI for treatment planning for radiation therapy or those who have completed treatment and are receiving follow up care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Successfully Contributing MRI Data
Time Frame: up to 4 weeks from imaging
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We tested these Advanced MR protocols to evaluate which ones would best visualize the target region.
This helped us determine the optimum MR SIM protocols for different sites that became clinical standard.
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up to 4 weeks from imaging
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ergun Ahunbay, PhD, Medical College of Wisconsin
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
February 1, 2009
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
September 10, 2014
First Submitted That Met QC Criteria
January 13, 2015
First Posted (Estimate)
January 19, 2015
Study Record Updates
Last Update Posted (Actual)
October 31, 2017
Last Update Submitted That Met QC Criteria
October 30, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Advanced MRI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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.