Modeling Organ Motion During Abdominal Imaging in Healthy Volunteers

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Other: MRI

• Registration Number: NCT05674851
• Lead Sponsor: Duke University

Brief 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.

Study Timeline

• Study First Submitted: 2022-12-22
• Study First Submitted QC: 2022-12-22
• Study First Posted: 2023-01-09
• Study Start: 2023-05-23
• Primary Completion: 2023-06-27
• Study Completion: 2023-06-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy Volunteer MRI	MRI	-

Primary Outcome Measures

Name	Time	Method
abdominal respiratory motion as measured by MRI	baseline
gastrointestinal motility motion as measured by MRI	baseline
inter-fractional motion as measured by MRI	baseline, up to 6 months	inter-fractional motion is defined as the change in motion of organs and tissues between different image examinations on different days

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States