Modeling Organ Motion During Abdominal Imaging in Healthy Volunteers

NCT ID: NCT05674851

Last Updated: 2025-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-23

Study Completion Date

2023-06-27

Brief Summary

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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

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Healthy Volunteer MRI

Group Type EXPERIMENTAL

MRI

Intervention Type OTHER

collection of MRI scans for mathematical model development

Interventions

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MRI

collection of MRI scans for mathematical model development

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Ginn, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University Health System (DUHS)

Deshan Yang, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University Health System (DUHS)

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00111970

Identifier Type: -

Identifier Source: org_study_id

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