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NCT Number: NCT02246634

Screening for Synchronous Metastases in Colorectal Cancer With DW-MRI (SERENADE)

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.

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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Hepatic Neoplasms Intestinal Diseases Intestinal Neoplasms Liver Diseases Liver Neoplasms Neoplasm Metastases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Neoplasms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Macclesfield District General Hospital, Macclesfield, Cheshire, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Diffusion Weighted MRI scan

Other

Liver metastases found on the additional DW-MRI scans will be discussed at MDT and treated according to local site policy.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

    % of patients diagnosed with liver metastases according to known prognostic risk factors

  2. 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)

    % 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.

  3. 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

    Survival and recurrence outcomes according to presence or absence of liver metastases

  4. 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)

    Fong score of all patients with liver metastases

  5. 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)

    Proportion of patients undergoing curative treatment and methods of treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline Martin

CONTACT

[email protected]

+44 (0) 7749 655 817

Syvella Ellis

CONTACT

[email protected]

+44 (0) 7732 315 234

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Pelican Cancer Foundation

Registry information

Official study title

Screening for Synchronous Metastases in Colorectal Cancer With DW-MRI.

Acronym: SERENADE

Important dates

Study start
2014
Primary completion
2026
Study completion
2031
First posted
Sep 23, 2014
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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