QUANTUM: Quantification of Abdominal Organ Motion Using MRI

Sponsor

The Christie NHS Foundation Trust (Other)

Overall Status

Recruiting

CT.gov ID

NCT04748094

Collaborator

(none)

Enrollment

Location

14.3

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Device: Compression belt Other: Visual Guided Breath-hold

Study Design

Study Type:

Observational

Anticipated Enrollment :

26 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 21, 2021

Anticipated Primary Completion Date :

Jul 31, 2022

Anticipated Study Completion Date :

Jul 31, 2022

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Christie NHS Foundation Trust	Manchester	Greater Manchester	United Kingdom	M20 4BX

Sponsors and Collaborators

The Christie NHS Foundation Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Christie NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT04748094

Other Study ID Numbers:

CFTSp166

First Posted:

Feb 10, 2021

Last Update Posted:

Feb 3, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by The Christie NHS Foundation Trust

MRI

Study Results

No Results Posted as of Feb 3, 2022