4D-MRI for Precision Medicine
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-82
SponsorUniversity of Virginia
About this trial
The purpose of this study is to develop new ways to make medical images of the lungs and liver of adults using a technique called four-dimensional magnetic resonance imaging (4D-MRI). This technique produces three-dimensional movies of the inside of the chest and abdomen while the patient is breathing. (The fourth dimension is time!)
This new way of medical imaging is being developed to help cancer patients undergoing radiation therapy. Radiation therapy is used to treat cancerous tumors. For radiation therapy to be effective, the precise size, shape, and location of the tumor within the body must be known. A particular difficulty for radiation treatment of lung and liver cancer is that the tumor moves during treatment because the patient is breathing. Therefore, tumor motion must also be incorporated into the treatment plan. This study aims to improve radiation treatment planning through better targeting and dose estimation based on 4D-MRI. Before this new imaging method can be used for radiation treatment planning, it must be tested in living, breathing volunteers.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patient is 21 or older
Patient has primary or metastatic tumor(s) in the lungs or the liver
Diameter of the tumor(s) is less than 7 cm
Patient will receive radiation therapy (ordered by the treating Radiation Oncologist) as part of their treatment regimen
Disqualifiers
Any condition for which a MRI procedure is contraindicated including presence of metallic material in the body, such as pacemakers, non- MRI compatible surgical clips, shrapnel, etc.
Subjects who have difficulty lying flat on their back for extended periods of time
Patients with any serious/poorly controlled medical or psychological conditions that would complicate protocol compliance
Too large to adequately fit in the magnet bore or RF coils
Trial population
Up to 30 lung cancer patients, 30 liver cancer patients, and 40 healthy human volunteers will receive MRI examinations at the University of Virginia to directly measure respiratory motion in the thorax and abdomen. All subject populations will include roughly equal male and female representations. The subject populations will have minority and ethnic representation typical of the local population area that includes the University of Virginia. No specific racial or ethnic group will be excluded. All subjects must have the ability to understand the requirements of the study and must provide informed consent with a personal signature. No persons from vulnerable populations will be included in this study.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Magnetic Resonance Imaging
Diagnostic testFour-dimensional MRI of torso
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: Healthy1 intervention
Group B: Liver cancer1 intervention
Group C: Lung cancer1 intervention
Trial outcomes
Primary outcomes
1
Image quality metrics in healthy volunteers
General 4D-MRI image quality will be assessed based on signal-to-noise ratio, number of distinct images per breathing cycle, total necessary imaging time, and image quality index.
Time frame
single imaging session, lasting up to 2 hours2
Image quality metrics in cancer patients
We hypothesize that our ultra-quality 4D-MRI methodology will outperform 4D-CT for motion management of radiotherapy in the lungs and the liver. We will test this hypothesis by comparing image quality based on tumor volume consistency, number of trackable landmarks, motion measurement accuracy, and image quality index.
Time frame
single imaging session, lasting up to 2 hours3
DVF errors in healthy volunteers and cancer patients
We hypothesize that our motion modeling method based on 4D-MRI will outperform current DIR algorithms for respiratory motion estimation. We will test this hypothesis by comparing our method to five existing DIR algorithms, based on the magnitude error (Em) and the angular error (Ea) of the calculated deformation vector field (DVF).
Time frame
single imaging session, lasting up to 2 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Virginia
Lead sponsor
Duke University
Collaborator
The Hong Kong Polytechnic University
Collaborator
Source ClinicalTrials.gov