Cancer Clinical Trial - Solid Tumor Imaging MR-Linac (STIM Study)

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

The objectives of this study are: 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. ;

Study Design

Related Conditions & MeSH terms

Cancer

Clinical Trial Details

NCT number	NCT03500081
Study type	Observational
Source	Medical College of Wisconsin
Contact	Medical College of Wisconsin Clinical Cancer Center
Phone	414-805-8900
Email	cccto@mcw.edu
Status	Recruiting
Phase
Start date	October 2, 2017
Completion date	December 1, 2029

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.