Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Imaging and Plan Workflow in a Novel Low-Field Magnetic Resonance Imaging (MRI) Radiotherapy Device

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: NCT02331381
Recruitment Status : Terminated (Low accrual)
First Posted : January 6, 2015
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
The results of this imaging and treatment planning protocol will aid in developing procedures for patient localization and future clinical implementation of low-field MRI to confirm positioning prior to radiation treatment. Images acquired during this study may aid future study design for adaptive planning based on low-field MRI images. Moreover, results of this imaging and treatment planning may lead to guidance on optimal use of this novel device.

Condition or disease Intervention/treatment Phase
Cancer Malignant Tumor Device: Magnetic resonance imaging Phase 1

Detailed Description:

Recently, Viewray Inc (Cleveland, OH) has released the RenaissanceTM System 1000, which consists of the combination of an open, split solenoid 0.35 T MRI scanner that is equipped for parallel imaging with a 60Co gamma-ray radiation treatment unit. The MRI scanner is required to be a low field unit to allow for imaging with spatial integrity by limiting magnetic susceptibility artifacts due to the patient and to prevent significant perturbations of the dose distribution. The 0.35 T magnet is a variant of the Siemens MAGNETOM product used for intraoperative imaging.

A previous study of pilot imaging using this device without the 60Co sources was completed in 2012 (HRPO# 201105295). In this study, a total of 26 patients were imaged with the device. Fourteen of these patients also had onboard CT imaging (OB-CT) where the two sets of imaging and relative organs at risk (OARs) could be compared. Fifteen to 24 OARs were evaluated per anatomical site. In total, 221 OARs and 10 target structures were compared for visualization on MRI and OB-CT image sets by each physician. At least 2/3 physicians evaluated MRI as offering better visualization for 71% of structures, OB-CT offering better visualization for 10% of structures, and both offering equivalent visualization for 14% of structures. Physicians agreed unanimously for 74% and in majority for >99% of structures evaluated, respectively. For <1% of structures, no consensus was reached. Targets were better visualized on MRI in 4/10 cases, and were never better visualized on OB-CT images.

There were limitations to this prior study. The patients were not imaged in immobilization devices that are commonly used in radiation therapy. This precluded the creation of a mock radiation therapy plan using the device for these patients. Also, the device was not evaluated in the context of radiation therapy decision making, such as patient shifts, target localization and patient repositioning.

The purpose of this study is to evaluate the imaging and plan workflow for radiation therapy utilizing this novel device. For this protocol, only the MRI scanner of the machine will be utilized. The 60Co portion of the machine capable of radiation treatment administration will not be utilized, and there will be no experimental treatments or modifications to each patient's standard of care radiation treatment plan.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study of Imaging and Plan Workflow in a Novel Low-Field Magnetic Resonance Imaging (MRI) Radiotherapy Device
Actual Study Start Date : December 26, 2013
Actual Primary Completion Date : December 23, 2015
Actual Study Completion Date : September 7, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MRI
Participants will have a custom immobilization device created for them for the purpose of the study. They will be scanned from one to four occasions during radiation treatment. If enrolled in the study prior to the first radiation treatment, the first imaging scan may be scheduled prior to the first radiation treatment, with subsequent scans during treatment separated by at least one day. Patients will be in the scanner for approximately 30 minutes to one hour, either prior to or following their standard of care radiotherapy treatment.
Device: Magnetic resonance imaging
Other Name: MRI




Primary Outcome Measures :
  1. Adequacy of the radiation therapy plan [ Time Frame: Duration of radiation therapy ]
    The radiation plan will be evaluated based on the recorded clinical goals prescribed by the attending physician. Plans will be classified as 'adequate' if they meet the prescribed goals for the clinical radiation therapy plan.

  2. Feasibility of patient localization workflow [ Time Frame: Duration of radiation therapy ]
    The localization time will be classified as 'adequate' if it is less than or equal to 15 minutes.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Eligibility Criteria:

  • Scheduled to receive radiation therapy.
  • At least 18 years of age.
  • Does not meet any standard contraindications for MRI (such as being claustrophobic, having metal objects within the body that cannot be removed or having large tattoos), confirmed by completion of our clinical MRI questionnaire form
  • Able to understand and willing to sign an IRB approved written informed consent document.

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): NCT02331381


Locations
Layout table for location information
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Layout table for investigator information
Principal Investigator: Jeff Michalski, M.D. Washington University School of Medicine
Additional Information:
Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02331381    
Other Study ID Numbers: 201311081
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms