Quantification of Abdominal Organ Motion Using MRI (QUANTUM)

February 10, 2023 updated by: The Christie NHS Foundation Trust

Quantification of Abdominal Organ Motion Using Magnetic Resonance Imaging (MRI)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M20 4BX
        • Recruiting
        • The Christie NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients or staff at The Christie NHS Foundation Trust

Description

Inclusion Criteria:

Healthy volunteers

  • 18 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI Motion Management SOP
Time Frame: through study completion, approximately 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantification of motion
Time Frame: through study completion, approximately 6 months
Quantification of intra-abdominal inter and intra-fraction motion with and without abdominal compression and visually guided breath holds using MR imaging. Comparative analysis of comparable treatment plans with and without abdominal compression and visually guided breath holds on relevant treatment planning software for PBT and MRL. Development of process to evaluate patient compliance when using a commercial available abdominal compression belt and visually guided breath-hold.
through study completion, approximately 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Christie NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 21, 2021

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

January 27, 2021

First Submitted That Met QC Criteria

February 8, 2021

First Posted (ACTUAL)

February 10, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2023

Last Update Submitted That Met QC Criteria

February 10, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CFTSp166

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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