Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
295 participants
OBSERVATIONAL
2017-10-02
2029-12-01
Brief Summary
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Detailed Description
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1. Improve variables related to MR image quality (e.g., signal-to-noise ratio, image contrast, acquisition time, etc.) between initial software configurations, standard-of-care images, and each newly improved software version.
2. Determine the feasibility of the MR- guided adaptive work flow for MR-linac radiation therapy. This will include improvement in variables related to simulated (i.e., not given to the patient) MRI radiation treatment delivery (e.g., contours, auto segmentation software, organ deformation and volume change, etc.) to determine the feasibility of intra- and interfraction adaptive radiation therapy.
3. Obtain imaging data (cancer patients all standard- of- care scans) and clinical data from participants, for additional research focused on MRI use for radiation therapy, which hypothesis-driven research protocols may access.
4. Obtain MRI scans from cancer patients and 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. These images will be completely de-identified for the purposes of collaboration with researchers from other institutions, other industry partners and ELEKTA Inc. These images will be stored and may be used by Elekta, industry partners and the MR-linac Consortium for technology development, user trainings, and/or product marketing purposes.
5. Translational genomic biomarker study will be conducted with existing biopsy tissue samples to determine how genomic predictors of radiation response may correlate with tumor changes as seen on MRIs acquired during treatment.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cancer Patients
Cancer patients with any solid tumor type planning to undergo a course of radiation therapy. Seventy-five patients in this group with any solid tumor type will consent to the genomic biomarker sub-study, which will be conducted with biopsy tissue samples to determine how genomic predictors of radiation response may correlate with tumor changes as seen on MRIs acquired during treatment.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Healthy volunteers (may be from the Department of Radiation Oncology faculty and staff, family and friends of the Department of Radiation Oncology faculty and staff and Cancer Center faculty and staff) will sign an IRB- approved consent form, give demographic information and complete the MRI eligibility checklist. The MRI scans will be performed outside normal working hours.
* Ability and willingness to provide written informed consent. For the genomic biomarkers studies, patients will sign an additional consent form for tissue and genomic testing.
* All subjects (including patients and healthy volunteers) will complete the MRI history form.
* For the genomic biomarkers sub-study: biopsy tissue availability that will not be exhausted during the preparation of specimen for genomic assessment.
Exclusion Criteria
* Pregnant people.
* People with MRI contraindicated conditions as evaluated during routine MR screening.
18 Years
ALL
Yes
Sponsors
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Medical College of Wisconsin
OTHER
Responsible Party
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William Hall
Professor
Principal Investigators
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William Hall, MD
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Locations
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Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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PRO 30440
Identifier Type: -
Identifier Source: org_study_id