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Solid Tumor Imaging MR-Linac (STIM Study)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03500081
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : August 31, 2020
Sponsor:
Information provided by (Responsible Party):
William Hall, Medical College of Wisconsin

Brief Summary:
The use of MRI imaging and image fusion in radiation therapy has dramatically increased during the past decade. However, the existing MRI-imaging protocols, imaging software and pulse sequences are all optimized for diagnostic purposes. With the introduction of the MR-linac, there is a critical and imminent need to develop imaging protocols that build and adapt the existing imaging parameters within the scope of the FDA-approved software to acquire MRI images that have less geometric distortion and better spatial resolution.

Condition or disease Intervention/treatment
Cancer Device: MRI Scan

Detailed Description:

The objectives of this study are:

  1. To evaluate and optimize advanced magnetic resonance (MRI) imaging pulse sequences for patients undergoing radiation treatment;
  2. To investigate the feasibility of using weekly MRI to assess anatomic and functional treatment responses of tumors and critical organs during radiation therapy (RT), thus enabling adaptive radiation therapy;
  3. To obtain imaging data and clinical data from participants, for additional research focused on MRI use for radiation therapy, hypothesis-driven research protocols may access;
  4. To obtain MRI scans from healthy volunteers from the Department of Radiation Oncology. These scans will be used to optimize scanning parameters for various body sites and to identify appropriate positioning methods for future patient treatments.

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Study Type : Observational
Estimated Enrollment : 295 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Solid Tumor Imaging MR-Linac (STIM Study)
Actual Study Start Date : October 2, 2017
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cancer Patients
Cancer patients with any solid tumor type planning to undergo a course of radiation therapy.
Device: MRI Scan
The MRI scan will not be used for diagnostic purposes. The research team members do not use the sequences for detection of clinical conditions. This is an observational study only, with no interventions.

Healthy Volunteers
Faculty members in the Department of Radiation Oncology have volunteered to participate in this research project. They are investigators and are interested in the abilities of this new machine(MR-Linac) and the potential benefits to patients who will be treated in their department. These scans will be used to optimize scanning parameters for various body sites and to identify appropriate positioning methods for future patient treatments.
Device: MRI Scan
The MRI scan will not be used for diagnostic purposes. The research team members do not use the sequences for detection of clinical conditions. This is an observational study only, with no interventions.




Primary Outcome Measures :
  1. Determine the optimal set of scan parameters (e.g., field of view). [ Time Frame: Assessment will be done for each imaging sequence available for each subject at a specific time point. Up to 2 year recruitment period. ]
    This will be determined with both physics and physician review of acquired images



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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

There are two groups of participants:

A) Non-patient volunteers who will take part in non-patient volunteer imaging studies.

B) Patient volunteers who will take part in imaging studies.

Criteria

Inclusion Criteria:

  • Cancer patients with any solid tumor type planning to undergo a course of radiation therapy.
  • Healthy volunteers from the Department of Radiation Oncology staff will sign an institutional review board (IRB) approved consent form and complete the MRI eligibility checklist. The MRI scans will be performed outside normal working hours.
  • Ability and willingness to provide written informed consent.
  • All subjects (including patients and healthy volunteers) will complete the MRI History form.

Exclusion Criteria:

  • People under 18 years of age.
  • Pregnant women.
  • People with MRI contraindicated conditions as evaluated during routine MR screening.

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): NCT03500081


Contacts
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Contact: Medical College of Wisconsin Clinical Cancer Center 414-805-8900 cccto@mcw.edu

Locations
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United States, Wisconsin
Froedtert & the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Froedtert & the Medical College of Wisconsin Clinical Cancer Center    414-805-8900    cccto@mcw.edu   
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
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Principal Investigator: William Hall, MD Medical College of Wisconsin
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Responsible Party: William Hall, Assistant Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT03500081    
Other Study ID Numbers: PRO 30440
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: August 31, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes