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CompletedNCT05674851Updated Jan 6, 2025

Modeling Organ Motion During Abdominal Imaging in Healthy Volunteers

An interventional study of MRI in Healthy Volunteers, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-06.

Sponsored by Duke University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • Magnetic Resonance Imaging (MRI)
  • Abdominal Cancer
  • Radiation Therapy Planning
03

In context

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • None
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    Healthy Volunteer MRI

    Other: MRI

Interventions

  • OtherMRI

    collection of MRI scans for mathematical model development

06

What researchers measure

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

    inter-fractional motion is defined as the change in motion of organs and tissues between different image examinations on different days

    Time frame: baseline, up to 6 months

07

Study locations

1 site
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05674851
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Jan 9, 2023
Start date
May 23, 2023
Primary completion
Jun 27, 2023
Completion
Jun 27, 2023
Last update
Jan 6, 2025

Study contacts

John Ginn, PhD
principal investigator · Duke University Health System (DUHS)
Deshan Yang, PhD
principal investigator · Duke University Health System (DUHS)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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