CancerCeleScan-RNCT05380609
Accelerated Body Diffusion-Weighted MRI Using Artificial Intelligence
An observational study of Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 450 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 May 2022to Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Cancer patients
Who may be able to join
None listed.
Who cannot join
- No exclusion criteria as this is a retrospective data study only.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Radiology, The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
About this study
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.
Read more
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.
- Conditions
- Cancer
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Throughout study completion, 3 years
Secondary outcomes (4)
Qualitative contrast-to-noise-ratio comparison
Qualitative radiological contrast-to-noise-ratio (CNR) on a 5-point Likert scale (5 being the best), for quickDWI images and conventional clinical images.
Measured: Throughout study completion, 3 years
Qualitative artefact comparison
Qualitative scoring for presence of image artefacts on a 5-point Likert scale (5 being the best), for quickDWI images and conventional clinical images.
Measured: Throughout study completion, 3 years
Inter-observer comparison
Krippendorff's alpha coefficient for inter-observer agreement of image quality, CNR and image artefacts.
Measured: Throughout study completion, 3 years
Repeatability comparison
The coefficient of repeatability of median ADC measurements within regions-of-interest (ROIs) defined in the same anatomical areas on both quickDWI and standard clinical imaging.
Measured: Throughout study completion, 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start6 May 2022
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380609
- Sponsor's protocol ID
- CCR5653
- Acronym
- CeleScan-R
- Status last verified
- May 2022
- First submitted
- 9 May 2022
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Body Diffusion-Weighted MRI Using Artificial Intelligence
- ClinicalTrials.gov ID
- NCT05380609
- Acronym / sponsor ID
- CeleScan-R / CCR5653
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- 6 May 2022 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Cancer patients
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- No exclusion criteria as this is a retrospective data study only.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Qualitative image comparison
Time frame: Throughout study completion, 3 years
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.
4 secondary outcomes
Qualitative contrast-to-noise-ratio comparison
Time frame: Throughout study completion, 3 years
Qualitative artefact comparison
Time frame: Throughout study completion, 3 years
Inter-observer comparison
Time frame: Throughout study completion, 3 years
Repeatability comparison
Time frame: Throughout study completion, 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
Related trials for Cancer
Enrolling by invitation
Exercise Intervention for Breast Cancer Patients With Sarcopenia
Sarcopenia, Breast Cancer
RecruitingPhase 3
A Study Comparing TAK-928 With Docetaxel in Adults With Non-Small Cell Lung Cancer
IO Resistant Squamous and Nonsquamous NSCLC
Not yet recruitingPhase 2
Saruparib in HRDsig+ Solid Tumors
Malignant Neoplastic Disease (Disorder)
RecruitingPhase 2
IGFBP-2 Vaccine to Prevent Ovarian Cancer Progression in Patients With Serologic Detection of Recurrence
Fallopian Tube Carcinoma, Ovarian Carcinoma
Not yet recruitingPhase 2
Nemtabrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) Refractory to Covalent Bruton Tyrosine Kinase Inhibitor or Pirtobrutinib and Previously Treated With a BCL2 Inhibitor
Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative image comparison (time frame: Throughout study completion, 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.