NCT05674851

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 9, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

May 23, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2023

Completed
Last Updated

January 6, 2025

Status Verified

January 1, 2025

Enrollment Period

1 month

First QC Date

December 22, 2022

Last Update Submit

January 3, 2025

Conditions

Healthy Volunteers

Keywords

Magnetic Resonance Imaging (MRI)Abdominal CancerRadiation Therapy Planning

Outcome Measures

Primary Outcomes (3)

  • abdominal respiratory motion as measured by MRI

    baseline

  • gastrointestinal motility motion as measured by MRI

    baseline

  • 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

Study Arms (1)

Healthy Volunteer MRI

EXPERIMENTAL
Other: MRI

Interventions

MRIOTHER

collection of MRI scans for mathematical model development

Healthy Volunteer MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Study Officials

  • John Ginn, PhD

    Duke University Health System (DUHS)

    PRINCIPAL INVESTIGATOR

  • Deshan Yang, PhD

    Duke University Health System (DUHS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2022

First Posted

January 9, 2023

Study Start

May 23, 2023

Primary Completion

June 27, 2023

Study Completion

June 27, 2023

Last Updated

January 6, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)