NCT03500081

Solid Tumor Imaging MR-Linac (STIM Study)

• Status: Suspended
• Phase: —
• Study type: Observational
• Enrollment: 295 (estimated)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-10-02
• Primary completion: 2027-12-01
• Completion: 2029-12-01
• First posted: 2018-04-17
• Last updated: 2026-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study