Solid Tumor Imaging MR-Linac (STIM Study)

NCT03500081 | Suspended DMC FDA Device

• 1 other identifier: PRO 30440
• Study Type: observational
• Target: 295
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Determine the optimal set of scan parameters (e.g., field of view).

  This will be determined with both physics and physician review of acquired images

  Assessment will be done for each imaging sequence available for each subject at a specific time point. Up to 2 year recruitment period.

Study Arms (2)

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.

Device: MRI Scan

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

Interventions

MRI Scan DEVICE

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.

Cancer Patients; Healthy Volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Cancer patients with any solid tumor type planning to undergo a course of radiation therapy.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

A translational genomic biomarker sub-study (75 subjects) 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.

MeSH Terms

Conditions

Neoplasms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• William Hall, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 17, 2018
• Study Start: October 2, 2017
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)