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Trial Title:
Modeling Organ Motion During Abdominal Imaging in Healthy Volunteers
NCT ID:
NCT05674851
Condition:
Healthy Volunteers
Conditions: Keywords:
Magnetic Resonance Imaging (MRI)
Abdominal Cancer
Radiation Therapy Planning
Study type:
Interventional
Study phase:
N/A
Overall status:
Suspended
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
MRI
Description:
collection of MRI scans for mathematical model development
Arm group label:
Healthy Volunteer MRI
Summary:
In this study, we plan to systematically analyze the motion of organs and tissues in the
abdomen, to understand the physical mechanisms of three-dimensional (3D) motion and
interactions of abdominal organs and tissues. This work will allow us to learn how to
mathematically model and predict abdominal organ motion.
Detailed description:
Specifically, we plan to conduct this study in 3 steps, in an order of increasing
complexity, starting with the (intra-fractional) respiratory only motion, then adding
intra-fractional GI motility motion, and finally the inter-fractional anatomical
variations (adding food intakes and fecal excretion). The research methods described will
allow the study team to develop the ability to estimate the motion of both tumor target
and critical organs given the patient's MRI, CBCT or x-ray fluoroscopy images on the day
of radiation treatment.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- No contraindications for MRI (e.g., unsafe MRI implanted devices, shrapnel, history
of metal fragments in eyes, neurostimulators, body habitus, claustrophobia).
- May have pre-existing medical conditions provided they are capable of completing the
exam and their condition is not expected to affect the physical tissue properties of
the organs that will be imaged.
- Women of child-bearing potential must verbally confirm lack of pregnancy prior to
signing consent
Exclusion Criteria:
- None
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Duke University Medical Center
Address:
City:
Durham
Zip:
27710
Country:
United States
Start date:
May 23, 2023
Completion date:
June 2026
Lead sponsor:
Agency:
Duke University
Agency class:
Other
Source:
Duke University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05674851
