Healthy VolunteersNCT05674851
Modeling Organ Motion During Abdominal Imaging in Healthy Volunteers
A study testing MRI in people with Healthy Volunteers, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2023to 27 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Study and Modeling of Organ Motion During Abdominal Imaging
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.
- Conditions
- Healthy Volunteers
- Being tested
- MRI
- Keywords
- Magnetic Resonance Imaging (MRI), Abdominal Cancer, Radiation Therapy Planning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
collection of MRI scans for mathematical model development
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteer MRI | Experimental | Not described Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
abdominal respiratory motion as measured by MRI
Measured: baseline
gastrointestinal motility motion as measured by MRI
Measured: 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
Measured: baseline, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start23 May 2023
- Primary completion27 Jun 2023
- Study completion27 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Ginn, PhD, Principal investigator, Duke University Health System (DUHS)Deshan Yang, PhD, Principal investigator, Duke University Health System (DUHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674851
- Sponsor's protocol ID
- Pro00111970
- Status last verified
- Jan 2025
- First submitted
- 22 Dec 2022
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study and Modeling of Organ Motion During Abdominal Imaging
- ClinicalTrials.gov ID
- NCT05674851
- Acronym / sponsor ID
- Pro00111970
- Conditions
- Healthy Volunteers
- Keywords
- Magnetic Resonance Imaging (MRI), Abdominal Cancer, Radiation Therapy Planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 23 May 2023 (actual)
- Primary completion
- 27 Jun 2023 (actual)
- Study completion
- 27 Jun 2023 (actual)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteer MRI | Experimental | Other: MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIcollection of MRI scans for mathematical model development | Other | Healthy Volunteer MRI |
Primary outcome
abdominal respiratory motion as measured by MRI
Time frame: baseline
gastrointestinal motility motion as measured by MRI
Time frame: baseline
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Ginn, PhD principal investigator
Duke University Health System (DUHS)
Deshan Yang, PhD principal investigator
Duke University Health System (DUHS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Healthy Volunteers, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
abdominal respiratory motion as measured by MRI (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.