Quantification of Abdominal Organ Motion Using MRI

Cancer Clinical Trial

— QUANTUM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04748094
• Other study ID #: CFTSp166
• Status: Recruiting
• Start date: May 21, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: The Christie NHS Foundation Trust
• Contact: Rachel Burgess, PhD
• Phone: +44 (0)161 918 7029
• Email: rachel.burgess[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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)

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.

Locations

Country	Name	City	State
United Kingdom	The Christie NHS Foundation Trust	Manchester	Greater Manchester

Sponsors (1)

Lead Sponsor	Collaborator
The Christie NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quantification of motion	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