NCT04748094

Brief Summary

The primary aim of the study is to quantify abdominal motion in order to optimise MR imaging. The study will compare three-motion management strategies a) free-breathing, b) using an abdominal compression belt and c) using MRI-compatible visually guided breath-holds.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2021

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

January 27, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

May 21, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2023

Completed
Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

1.8 years

First QC Date

January 27, 2021

Last Update Submit

August 21, 2025

Conditions

Keywords

MRI

Outcome Measures

Primary Outcomes (1)

  • MRI Motion Management SOP

    Development and implementation of an MRI protocol suitable for organ motion characterisation for the abdomen. Determination of the benefit of motion management strategies for abdominal radiotherapy.

    through study completion, approximately 6 months

Secondary Outcomes (1)

  • Quantification of motion

    through study completion, approximately 6 months

Study Arms (2)

Free-breathing versus Compression

This cohort of volunteers and patients will undergo imaging on the MR-Linac investigating free-breathing motion, and comparing it to motion using an abdominal compression device.

Device: Compression belt

Free-breathing versus Breath-holding

This cohort of volunteers and patients will undergo imaging on the MRSim investigating free-breathing motion and comparing it to visually-guided breath-hold motion (and reproducibility).

Other: Visual Guided Breath-hold

Interventions

The abdominal belt is fastened around the lower abdomen and inflated (like an inner tube) to apply pressure to the belly and reduce the motion associated with respiration (breathing)

Free-breathing versus Compression

A small tracer will be place on the lower abdomen that will feedback to a computer screen that will have graphics to show you if the participant is in breath-hold or not.

Free-breathing versus Breath-holding

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients or staff at The Christie NHS Foundation Trust

You may qualify if:

  • Healthy volunteers
  • years or older,
  • no MRI contra-indications
  • must agree to registration as a non-patient in CWP (the local electronic healthcare records system) and have their MRIs read and reviewed for incidental findings by a clinical radiologist
  • Patient Volunteers
  • undergoing radiotherapy to the abdominal region at the Christie NHS Foundation Trust
  • Over 18 years of age

You may not qualify if:

  • Any contraindications to MRI identified after MRI safety screening including completion of an MRI Safety Screening Form
  • Unable to tolerate MRI scan
  • Pregnancy
  • Colostomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Christie NHS Foundation Trust

Manchester, Greater Manchester, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2021

First Posted

February 10, 2021

Study Start

May 21, 2021

Primary Completion

March 15, 2023

Study Completion

March 15, 2023

Last Updated

August 27, 2025

Record last verified: 2025-08

Locations