Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT03500081 |
Other study ID # |
PRO 30440 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
October 2, 2017 |
Est. completion date |
December 1, 2029 |
Study information
Verified date |
November 2023 |
Source |
Medical College of Wisconsin |
Contact |
Medical College of Wisconsin Clinical Cancer Center |
Phone |
414-805-8900 |
Email |
cccto[@]mcw.edu |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
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.
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.