Solid Tumor Imaging MR-Linac (STIM Study)

Sponsor

Medical College of Wisconsin (Other)

Overall Status

Recruiting

CT.gov ID

NCT03500081

Collaborator

(none)

295

Enrollment

Location

146

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Cancer	Device: MRI Scan

Detailed Description

The objectives of this study are:

To evaluate and optimize advanced magnetic resonance (MRI) imaging pulse sequences for patients undergoing radiation treatment;
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;
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;
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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

295 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Solid Tumor Imaging MR-Linac (STIM Study)

Actual Study Start Date :

Oct 2, 2017

Anticipated Primary Completion Date :

Dec 1, 2027

Anticipated Study Completion Date :

Dec 1, 2029

Arms and Interventions

Arm	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.

Arm

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Froedtert & the Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226

Sponsors and Collaborators

Medical College of Wisconsin

Investigators

Principal Investigator: William Hall, MD, Medical College of Wisconsin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

William Hall, Associate Professor, Medical College of Wisconsin

ClinicalTrials.gov Identifier:

NCT03500081

Other Study ID Numbers:

PRO 30440

First Posted:

Apr 17, 2018

Last Update Posted:

Jul 20, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Study Results

No Results Posted as of Jul 20, 2022