Quantification of Abdominal Organ Motion Using MRI

Recruiting

• Conditions: Cancer
• Interventions: Device: Compression belt; Other: Visual Guided Breath-hold

• Registration Number: NCT04748094
• Lead Sponsor: The Christie NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-27
• Study First Submitted QC: 2021-02-08
• Study First Posted: 2021-02-10
• Study Start: 2021-05-21
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-10
• Last Update Posted: 2023-02-13
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Free-breathing versus Compression	Compression belt	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.
Free-breathing versus Breath-holding	Visual Guided Breath-hold	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).

Primary Outcome Measures

Name	Time	Method
MRI Motion Management SOP	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.

Secondary Outcome Measures

Name	Time	Method
Quantification of motion	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.

Trial Locations

Locations (1)

The Christie NHS Foundation Trust; 🇬🇧 Manchester, Greater Manchester, United Kingdom