Modeling Organ Motion During Abdominal Imaging in Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title:

Study and Modeling of Organ Motion During Abdominal Imaging

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05674851
• Other study ID #: Pro00111970
• Status: Suspended
• Phase: N/A
• Start date: May 23, 2023
• Est. completion date: June 2026

Study information

• Verified date: October 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 25
• Est. completion date: June 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• MRI
collection of MRI scans for mathematical model development

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	abdominal respiratory motion as measured by MRI		baseline
Primary	gastrointestinal motility motion as measured by MRI		baseline
Primary	inter-fractional motion as measured by MRI	inter-fractional motion is defined as the change in motion of organs and tissues between different image examinations on different days	baseline, up to 6 months