Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2026-03-05 @ 10:47 AM
Study NCT ID:
NCT02246634
Status:
RECRUITING
Last Update Posted:
2024-10-17
First Post:
2014-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening for Synchronous Metastases in Colorectal Cancer With DW-MRI (SERENADE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 282}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2031-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-16', 'studyFirstSubmitDate': '2014-09-05', 'studyFirstSubmitQcDate': '2014-09-19', 'lastUpdatePostDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Liver metastases found on the additional DW-MRI scans will be discussed at MDT and treated according to local site policy.', 'timeFrame': '5 years after last recruit (end of trial)', 'description': 'Proportion of additional patients diagnosed with liver metastases on DW MRI compared with CT.'}], 'secondaryOutcomes': [{'measure': 'To compare the baseline risk factors of the primary tumour against the timing and pattern of metastatic disease relapse in the liver.', 'timeFrame': '5 years after last recruit (end of trial)', 'description': '% of patients diagnosed with liver metastases according to known prognostic risk factors'}, {'measure': 'To determine the sensitivity and specificity of DW-MRI as a screening method for liver lesions in patients with high risk colorectal cancer.', 'timeFrame': '5 years after last recruit (end of trial)', 'description': "% 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."}, {'measure': 'To describe the cancer specific disease free survival and overall survival outcomes in patients with and without liver metastases.', 'timeFrame': '6mth, 12mth, 18mth, 2yr, 3yr', 'description': 'Survival and recurrence outcomes according to presence or absence of liver metastases'}, {'measure': 'To characterise the patients diagnosed through screening with liver metastasis in the SERENADE study using the Fong criteria.', 'timeFrame': '5 years after last recruit (end of trial)', 'description': 'Fong score of all patients with liver metastases'}, {'measure': 'To describe the impact of MR screening on treatment received by patients who are diagnosed with liver metastases.', 'timeFrame': '5 years after last recruit (end of trial)', 'description': 'Proportion of patients undergoing curative treatment and methods of treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Colorectal Neoplasms', 'Neoplasm Metastases', 'Magnetic Resonance Imaging', 'Diffusion Weighted MRI', 'Hepatic Neoplasms', 'Tumors', 'Neoplasms, Rectal'], 'conditions': ['Colorectal Neoplasms', 'Neoplasm Metastases', 'Hepatic Neoplasms']}, 'descriptionModule': {'briefSummary': '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.\n\nFindings 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Have a high risk primary colorectal malignancy\n2. Have a negative CT or includes no confirmatory evidence of liver metastases\n3. Is able to undergo treatment if liver metastasis is found\n4. Have provided written informed consent to participate in the study\n5. Be aged 16 years or over\n\nExclusion Criteria:\n\n1. Have had a previous colorectal malignancy\n2. Have metastatic disease\n3. Have a synchronous second malignancy\n4. Are contraindicated for MRI\n5. Has a T3b or below low rectal tumour without EMVI or N1c'}, 'identificationModule': {'nctId': 'NCT02246634', 'acronym': 'SERENADE', 'briefTitle': 'Screening for Synchronous Metastases in Colorectal Cancer With DW-MRI (SERENADE)', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Screening for Synchronous Metastases in Colorectal Cancer With DW-MRI.', 'orgStudyIdInfo': {'id': 'DOCUMAS: 17HH4153'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diffusion Weighted MRI scan', 'description': 'Patients who are enrolled in the study will undergo an additional diffusion weighted MRI (T2W, DWI and ADC sequences) of the liver.', 'interventionNames': ['Other: Diffusion Weighted MRI scan']}], 'interventions': [{'name': 'Diffusion Weighted MRI scan', 'type': 'OTHER', 'description': 'Liver metastases found on the additional DW-MRI scans will be discussed at MDT and treated according to local site policy.', 'armGroupLabels': ['Diffusion Weighted MRI scan']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SK10 3BL', 'city': 'Macclesfield', 'state': 'Cheshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Pippa Hill', 'role': 'CONTACT', 'email': 'philippahill@nhs.net'}, {'name': 'Lesley Wilkinson', 'role': 'CONTACT', 'email': 'lesley.wilkinson8@nhs.net'}, {'name': 'Chris Smart', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Macclesfield District General Hospital', 'geoPoint': {'lat': 53.26023, 'lon': -2.12564}}, {'zip': 'DE13 0RB', 'city': 'Burton-on-Trent', 'state': 'Derbyshire', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Helena Cox', 'role': 'CONTACT', 'email': 'Helena.Cox@burtonft.nhs.uk'}, {'name': 'Manjusha Keni', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Queen's Hospital", 'geoPoint': {'lat': 52.80728, 'lon': -1.64263}}, {'zip': 'CM1 7ET', 'city': 'Chelmsford', 'state': 'Essex', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Lauren Shillito', 'role': 'CONTACT', 'email': 'lauren.shillito@meht.nhs.uk'}, {'name': 'Peng Lee', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Broomfield Hospital', 'geoPoint': {'lat': 51.73575, 'lon': 0.46958}}, {'zip': 'BL4 0JR', 'city': 'Bolton', 'state': 'Greater Manchester', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Raksha Mistry', 'role': 'CONTACT', 'email': 'Raksha.mistry@boltonft.nhs.uk'}, {'name': 'Gemma Faulkner', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Royal Bolton Hospital', 'geoPoint': {'lat': 53.58333, 'lon': -2.43333}}, {'zip': 'ME7 5NY', 'city': 'Gillingham', 'state': 'Kent', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Suzie Rayner', 'role': 'CONTACT', 'email': 'Suzie.Reyner@medway.nhs.uk'}, {'name': 'Iheoma Amaechi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medway Maritime Hospital', 'geoPoint': {'lat': 51.38914, 'lon': 0.54863}}, {'zip': 'M23 9LT', 'city': 'Wythenshawe', 'state': 'Manchester', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Lindsay Piper', 'role': 'CONTACT', 'email': 'Lindsay.Piper@UHSM.NHS.UK'}, {'name': 'Sarah Duff', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital of South Manchester & Manchester Royal Infirmary', 'geoPoint': {'lat': 53.38027, 'lon': -2.2654}}, {'zip': 'L7 8XP', 'city': 'Liverpool', 'state': 'Merseyside', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Matthew Noonan', 'role': 'CONTACT', 'email': 'Matthew.Noonan@rlbuht.nhs.uk'}, {'name': 'Catriona Farrell', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Royal Liverpool Hospital', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'ST4 6QG', 'city': 'Stoke-on-Trent', 'state': 'Staffordshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Julie Storer', 'role': 'CONTACT', 'email': 'Julie.storer@uhnm.nhs.uk', 'phone': '01782 672557'}, {'name': 'Michelle Swann', 'role': 'CONTACT', 'email': 'Michelle.Swann@uhnm.nhs.uk', 'phone': '01782 675859'}, {'name': 'Ravivarma Balasubramaniam', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Royal Stoke University Hospital', 'geoPoint': {'lat': 53.00415, 'lon': -2.18538}}, {'zip': 'SM2 5PT', 'city': 'Sutton', 'state': 'Surrey', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Cordelia Grant', 'role': 'CONTACT', 'email': 'cordelia.grant@rmh.nhs.uk'}, {'name': 'Christos Kontovounisios', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Royal Marsden Hospital', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}, {'zip': 'NP20 2UB', 'city': 'Newport', 'state': 'Wales', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Heeam Nassa', 'role': 'CONTACT', 'email': 'Heeam.Nassa@wales.nhs.uk'}, {'name': 'Mark Robinson', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Royal Gwent Hospital', 'geoPoint': {'lat': 51.58774, 'lon': -2.99835}}, {'zip': 'CV10 7DJ', 'city': 'Nuneaton', 'state': 'Warwickshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Pritpal Klear', 'role': 'CONTACT', 'email': 'Pritpal.Klear@geh.nhs.uk'}, {'name': 'Holly Lawrence', 'role': 'CONTACT', 'email': 'Holly.Lawrence@geh.nhs.uk'}, {'name': 'Jamal Abdulkarim', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'George Eliot Hospital', 'geoPoint': {'lat': 52.52323, 'lon': -1.46523}}, {'zip': 'SP2 8BJ', 'city': 'Salisbury', 'state': 'Wiltshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Ruth Casey', 'role': 'CONTACT', 'email': 'Ruth.Casey@salisbury.nhs.uk'}, {'name': 'Graham Branagan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Salisbury District Hospital', 'geoPoint': {'lat': 51.06931, 'lon': -1.79569}}, {'city': 'Portsmouth', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Nicola Gibbons', 'role': 'CONTACT', 'email': 'nicola.gibbons@porthosp.nhs.uk'}, {'name': 'Antony Higginson', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Queen Alexandra Hospital', 'geoPoint': {'lat': 50.79899, 'lon': -1.09125}}], 'centralContacts': [{'name': 'Caroline Martin', 'role': 'CONTACT', 'email': 'c.martin1@imperial.ac.uk', 'phone': '+44 (0) 7749 655 817'}, {'name': 'Syvella Ellis', 'role': 'CONTACT', 'email': 'giclinicaltrials@imperial.ac.uk', 'phone': '+44 (0) 7732 315 234'}], 'overallOfficials': [{'name': 'Gina Brown', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pelican Cancer Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}