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Optimization of MRI for Radiation Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02045381
Recruitment Status : Suspended (Enrollment and/or interactions/interventions temporarily paused due to COVID-19 and expected to resume in the future. This is not a suspension of IRB approval.)
First Posted : January 24, 2014
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Brief Summary:
Currently, appropriate patients undergo MRI imaging with immobilization and sequences optimized for diagnostic radiology purposes. Using a mutual information algorithm, these images are then registered to a treatment planning CT obtained with custom immobilization to minimize intra-and inter-treatment motion and positional variation. This image registration process is time-consuming and introduces additional layers of geometric uncertainty into what should be a highly precise treatment planning process. However, it is necessary, since radiation dose calculations cannot be performed on MRI data due to the lack of crucial density information. The investigator envisions CT-less treatment planning, using only MRI, due to superior imaging characteristics, fully integrated into the radiation oncology clinic. This study will begin this process.

Condition or disease Intervention/treatment
Cancer Liver Cancer Brain Cancer Head &Neck Cancer Pelvis Procedure: MRI Group

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Study Type : Observational
Estimated Enrollment : 432 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Optimization of MRI for Radiation Therapy
Study Start Date : February 2013
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2021

Group/Cohort Intervention/treatment
MRI group
Patient receives one research MRI prior to radiation treatment.
Procedure: MRI Group
A single research MRI




Primary Outcome Measures :
  1. Percentage of participants with MRI images suitable for analyses [ Time Frame: Day One ]
    Patients will be off protocol immediately after the single MRI scan. Comparative treatment planning will occur off-line and will not be used for patient care.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants having a working diagnosis of malignancy in the liver, brain, head and neck, or pelvis, and a plan to treat with radiotherapy.
Criteria

Inclusion Criteria:

  • Patients ≥18 years of age
  • A working diagnosis of malignancy in the liver, brain, H&N, or pelvis
  • A plan to treat with radiotherapy

Exclusion Criteria:

  • Patients with contraindications to having a contrast enhanced MRI scan. These contraindications will be assessed at the time of enrollment using the guidelines set up and in clinical use by the Radiology Department.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02045381


Locations
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United States, Michigan
Univeristy of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
Investigators
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Principal Investigator: Shruti Jolly, MD University of Michigan
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Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT02045381    
Other Study ID Numbers: UMCC 2012.113
HUM00068061 ( Other Identifier: University of Michigan )
First Posted: January 24, 2014    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Keywords provided by University of Michigan Rogel Cancer Center:
Cancer
MRI