Colorectal NeoplasmsSERENADENCT02246634
Screening for Synchronous Metastases in Colorectal Cancer With DW-MRI (SERENADE)
A study testing Diffusion Weighted MRI scan in people with Colorectal Neoplasms and Neoplasm Metastases, run by Imperial College London at 13 sites in United Kingdom.
Trial summary
Eligible patients with high risk colorectal malignancy (T3/4, spread greater than 5mm, EMVI positive) will have additional surveillance of breath hold T1, T2 and DW-MRIs (no IV contrast) post surgery six monthly for three years. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Colorectal Neoplasms, Neoplasm Metastases, Hepatic Neoplasms
- What is being tested?
- Diffusion Weighted MRI scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 13 sitesUnited Kingdom
- Study dates
- Aug 2014to Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have a high risk primary colorectal malignancy
- Have a negative CT or includes no confirmatory evidence of liver metastases
- Is able to undergo treatment if liver metastasis is found
- Have provided written informed consent to participate in the study
- Be aged 16 years or over
Who cannot join
- Have had a previous colorectal malignancy
- Have metastatic disease
- Have a synchronous second malignancy
- Are contraindicated for MRI
- Has a T3b or below low rectal tumour without EMVI or N1c
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United Kingdom13 sites, 13 recruiting
- Recruiting
Royal Bolton Hospital
Bolton, Greater Manchester, BL4 0JR
Raksha Mistry, Raksha.mistry@boltonft.nhs.uk
Gemma Faulkner
- Not yet recruiting
Queen's Hospital
Burton-on-Trent, Derbyshire, DE13 0RB
Helena Cox, Helena.Cox@burtonft.nhs.uk
Manjusha Keni
- Recruiting
Broomfield Hospital
Chelmsford, Essex, CM1 7ET
Lauren Shillito, lauren.shillito@meht.nhs.uk
Peng Lee
- Recruiting
Medway Maritime Hospital
Gillingham, Kent, ME7 5NY
Suzie Rayner, Suzie.Reyner@medway.nhs.uk
Iheoma Amaechi
- Recruiting
Royal Liverpool Hospital
Liverpool, Merseyside, L7 8XP
Matthew Noonan, Matthew.Noonan@rlbuht.nhs.uk
Catriona Farrell
- Recruiting
Macclesfield District General Hospital
Macclesfield, Cheshire, SK10 3BL
Pippa Hill, philippahill@nhs.net
Lesley Wilkinson, lesley.wilkinson8@nhs.net
- Recruiting
Royal Gwent Hospital
Newport, Wales, NP20 2UB
Heeam Nassa, Heeam.Nassa@wales.nhs.uk
Mark Robinson
- Recruiting
George Eliot Hospital
Nuneaton, Warwickshire, CV10 7DJ
Pritpal Klear, Pritpal.Klear@geh.nhs.uk
Holly Lawrence, Holly.Lawrence@geh.nhs.uk
- Recruiting
Queen Alexandra Hospital
Portsmouth
Nicola Gibbons, nicola.gibbons@porthosp.nhs.uk
Antony Higginson
- Recruiting
Salisbury District Hospital
Salisbury, Wiltshire, SP2 8BJ
Ruth Casey, Ruth.Casey@salisbury.nhs.uk
Graham Branagan
- Recruiting
Royal Stoke University Hospital
Stoke-on-Trent, Staffordshire, ST4 6QG
Julie Storer, 01782 672557, Julie.storer@uhnm.nhs.uk
Michelle Swann, 01782 675859, Michelle.Swann@uhnm.nhs.uk
- Recruiting
Royal Marsden Hospital
Sutton, Surrey, SM2 5PT
Cordelia Grant, cordelia.grant@rmh.nhs.uk
Christos Kontovounisios
- Recruiting
University Hospital of South Manchester & Manchester Royal Infirmary
Wythenshawe, Manchester, M23 9LT
Lindsay Piper, Lindsay.Piper@UHSM.NHS.UK
Sarah Duff
About this study
Official title: Screening for Synchronous Metastases in Colorectal Cancer With DW-MRI.
Eligible patients with high risk colorectal malignancy (T3/4, spread greater than 5mm, EMVI positive) will have additional surveillance of breath hold T1, T2 and DW-MRIs (no IV contrast) post surgery six monthly for three years.
Findings of liver MRIs as reported by radiology PI will be shared with their local MDT who make decisions as appropriate, including the management of any identified liver metastases, according to local protocol.
Read the detailed description
A phase II multicentre, interventional study to determine if additional staging at diagnosis with liver DW-MRI will diagnose more synchronous metastases than CT alone in patients with high risk colorectal cancer. Liver metastases found on the additional DW-MRI scans will be discussed at MDT and treated according to local policy.
- Conditions
- Colorectal Neoplasms, Neoplasm Metastases, Hepatic Neoplasms
- Being tested
- Diffusion Weighted MRI scan
- Keywords
- Colorectal Neoplasms, Neoplasm Metastases, Magnetic Resonance Imaging, Diffusion Weighted MRI, Hepatic Neoplasms, Tumors, Neoplasms, Rectal
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis, Liver Neoplasms, Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusion Weighted MRI scanOther
Liver metastases found on the additional DW-MRI scans will be discussed at MDT and treated according to local site policy.
| Study group | Role | What they receive |
|---|---|---|
| Diffusion Weighted MRI scan | Experimental | Patients who are enrolled in the study will undergo an additional diffusion weighted MRI (T2W, DWI and ADC sequences) of the liver. Receives: Other: Diffusion Weighted MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver metastases found on the additional DW-MRI scans will be discussed at MDT and treated according to local site policy.
Proportion of additional patients diagnosed with liver metastases on DW MRI compared with CT.
Measured: 5 years after last recruit (end of trial)
Secondary outcomes (5)
To compare the baseline risk factors of the primary tumour against the timing and pattern of metastatic disease relapse in the liver.
% of patients diagnosed with liver metastases according to known prognostic risk factors
Measured: 5 years after last recruit (end of trial)
To determine the sensitivity and specificity of DW-MRI as a screening method for liver lesions in patients with high risk colorectal cancer.
% lesions suspected as metastatic on DW MRI confirmed by subsequent 'gold standard' of contrast enhanced MRI and/or surgical resection, and/or progressive enlargement of the lesion.
Measured: 5 years after last recruit (end of trial)
To describe the cancer specific disease free survival and overall survival outcomes in patients with and without liver metastases.
Survival and recurrence outcomes according to presence or absence of liver metastases
Measured: 6mth, 12mth, 18mth, 2yr, 3yr
To characterise the patients diagnosed through screening with liver metastasis in the SERENADE study using the Fong criteria.
Fong score of all patients with liver metastases
Measured: 5 years after last recruit (end of trial)
To describe the impact of MR screening on treatment received by patients who are diagnosed with liver metastases.
Proportion of patients undergoing curative treatment and methods of treatment
Measured: 5 years after last recruit (end of trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2026 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 282 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Pelican Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Gina Brown, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246634
- Sponsor's protocol ID
- DOCUMAS: 17HH4153
- Acronym
- SERENADE
- Status last verified
- Oct 2024
- First submitted
- 5 Sep 2014
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Synchronous Metastases in Colorectal Cancer With DW-MRI.
- ClinicalTrials.gov ID
- NCT02246634
- Acronym / sponsor ID
- SERENADE / DOCUMAS: 17HH4153
- Conditions
- Colorectal Neoplasms, Neoplasm Metastases, Hepatic Neoplasms
- Keywords
- Colorectal Neoplasms, Neoplasm Metastases, Magnetic Resonance Imaging, Diffusion Weighted MRI, Hepatic Neoplasms, Tumors, Neoplasms, Rectal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 282 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Pelican Cancer Foundation
- Study start
- Aug 2014 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 23 Sep 2014 (estimated)
- 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.
Eligible patients with high risk colorectal malignancy (T3/4, spread greater than 5mm, EMVI positive) will have additional surveillance of breath hold T1, T2 and DW-MRIs (no IV contrast) post surgery six monthly for three years.
Findings of liver MRIs as reported by radiology PI will be shared with their local MDT who make decisions as appropriate, including the management of any identified liver metastases, according to local protocol.
Detailed description
A phase II multicentre, interventional study to determine if additional staging at diagnosis with liver DW-MRI will diagnose more synchronous metastases than CT alone in patients with high risk colorectal cancer. Liver metastases found on the additional DW-MRI scans will be discussed at MDT and treated according to local policy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diffusion Weighted MRI scan | Experimental | Other: Diffusion Weighted MRI scanPatients who are enrolled in the study will undergo an additional diffusion weighted MRI (T2W, DWI and ADC sequences) of the liver. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Have a high risk primary colorectal malignancy
- Have a negative CT or includes no confirmatory evidence of liver metastases
- Is able to undergo treatment if liver metastasis is found
- Have provided written informed consent to participate in the study
- Be aged 16 years or over
Key exclusion criteria (5 listed)
- Have had a previous colorectal malignancy
- Have metastatic disease
- Have a synchronous second malignancy
- Are contraindicated for MRI
- Has a T3b or below low rectal tumour without EMVI or N1c
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diffusion Weighted MRI scanLiver metastases found on the additional DW-MRI scans will be discussed at MDT and treated according to local site policy. | Other | Diffusion Weighted MRI scan |
Primary outcome
Liver metastases found on the additional DW-MRI scans will be discussed at MDT and treated according to local site policy.
Time frame: 5 years after last recruit (end of trial)
Proportion of additional patients diagnosed with liver metastases on DW MRI compared with CT.
5 secondary outcomes
To compare the baseline risk factors of the primary tumour against the timing and pattern of metastatic disease relapse in the liver.
Time frame: 5 years after last recruit (end of trial)
To determine the sensitivity and specificity of DW-MRI as a screening method for liver lesions in patients with high risk colorectal cancer.
Time frame: 5 years after last recruit (end of trial)
To describe the cancer specific disease free survival and overall survival outcomes in patients with and without liver metastases.
Time frame: 6mth, 12mth, 18mth, 2yr, 3yr
To characterise the patients diagnosed through screening with liver metastasis in the SERENADE study using the Fong criteria.
Time frame: 5 years after last recruit (end of trial)
To describe the impact of MR screening on treatment received by patients who are diagnosed with liver metastases.
Time frame: 5 years after last recruit (end of trial)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
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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.
Gina Brown principal investigator
Imperial College London
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diffusion Weighted MRI scan in people with Colorectal Neoplasms and Neoplasm Metastases, run by Imperial College London at 13 sites 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline Martin (+44 (0) 7749 655 817, c.martin1@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver metastases found on the additional DW-MRI scans will be discussed at MDT and treated according to local site policy. (time frame: 5 years after last recruit (end of trial)). 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 17 Oct 2024.