NCT05380609

Brief Summary

Whole-body diffusion-weighted MRI (WBDWI) is a non-invasive tool used for staging and response evaluation in oncologic practice and is at the core of emerging response criteria in advanced prostate and breast cancers. WBDWI is a sensitive tool that radiologists can use to review the extent of disease and is achieved using a series of sequential imaging stations from the head to the mid-thigh. WBDWI accounts for more than 50% of the acquisition time of conventional whole-body MRI studies with a 1-hour duration. Despite national and international guidance for using whole-body MRI, a recent UK survey indicated that only 27% of UK radiology departments were offering a whole-body MRI service with a lack of scanner availability cited by 50% of respondents as the main challenge to service delivery. In the context of the ever-increasing capacity pressures on MRI departments, reducing acquisition times would facilitate the wider adoption of clinical WBDWI, reduce costs, and improve the patient experience. DWI is also embedded into consensus MRI protocols across almost all tumour types including primary prostate and breast cancers, metastatic liver disease, gynaecological cancers \& GI cancers, where acquisition time savings could also be beneficial. The investigators have previously published accelerated DWI with deep learning based denoising filters (quickDWI), which can provide up to 50% reduction in whole-body MRI acquisition times. The goal of the deep-learning algorithm is to remove the noise in these subsampled images, producing an image with acceptable clinical quality. The aim of this investigation is to extend this work by testing quickDWI within a larger retrospective data cohort, incorporating other cancers such as disease of the abdomen and pelvis, primary prostate cancer, liver metastases, and pancreatic cancer.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

May 6, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 19, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

2.9 years

First QC Date

May 9, 2022

Last Update Submit

May 13, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Qualitative image comparison

    The primary endpoint is the qualitative comparison of radiological image quality on a 5-point Likert scale (5 being the best) for quickDWI images and conventional clinical images.

    Throughout study completion, 3 years

Secondary Outcomes (4)

  • Qualitative contrast-to-noise-ratio comparison

    Throughout study completion, 3 years

  • Qualitative artefact comparison

    Throughout study completion, 3 years

  • Inter-observer comparison

    Throughout study completion, 3 years

  • Repeatability comparison

    Throughout study completion, 3 years

Eligibility Criteria

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

Cancer patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiology, The Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Study Design

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

Study Record Dates

First Submitted

May 9, 2022

First Posted

May 19, 2022

Study Start

May 6, 2022

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

May 19, 2022

Record last verified: 2022-05

Locations