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OpenTrials
Completed

NCT Number: NCT05674851

Modeling Organ Motion During Abdominal Imaging in Healthy Volunteers

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Other

collection of MRI scans for mathematical model development

Primary outcomes

  1. abdominal respiratory motion as measured by MRI

    Time frame: baseline

  2. gastrointestinal motility motion as measured by MRI

    Time frame: baseline

  3. inter-fractional motion as measured by MRI

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Study and Modeling of Organ Motion During Abdominal Imaging

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 9, 2023
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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