Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2026-02-21 @ 11:07 AM
Study NCT ID:
NCT02403050
Status:
UNKNOWN
Last Update Posted:
2015-03-31
First Post:
2015-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study of Fiducial Markers in Oesophageal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057918', 'term': 'Fiducial Markers'}], 'ancestors': [{'id': 'D012015', 'term': 'Reference Standards'}, {'id': 'D014894', 'term': 'Weights and Measures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-25', 'studyFirstSubmitDate': '2015-03-16', 'studyFirstSubmitQcDate': '2015-03-25', 'lastUpdatePostDateStruct': {'date': '2015-03-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intra- and inter-observer variability of tumor target volume (cubic centimetres) estimation', 'timeFrame': 'baseline (pre-radiotherapy)', 'description': 'Comparison of intra- and inter-observer variability in estimation of tumor target volume (mean and standard deviation) in the prospective (fiducial markers) and retrospective (no fiducial markers) cohorts. Data will be reported using planning volumes measured in cubic centimetres.'}], 'secondaryOutcomes': [{'measure': 'Patient survival', 'timeFrame': '6 months post radiotherapy'}, {'measure': 'local recurrence of tumor', 'timeFrame': '6 months post radiotherapy', 'description': 'radiological or clinical evidence of disease recurrence'}, {'measure': 'Patient survival', 'timeFrame': '12 months post radiotherapy'}, {'measure': 'local recurrence of tumor', 'timeFrame': '12 months post radiotherapy', 'description': 'radiological or clinical evidence of disease recurrence'}, {'measure': 'Patient survival', 'timeFrame': '18 months post radiotherapy'}, {'measure': 'local recurrence of tumor', 'timeFrame': '18 months post radiotherapy', 'description': 'radiological or clinical evidence of disease recurrence'}, {'measure': 'Patient survival', 'timeFrame': '2 years post radiotherapy'}, {'measure': 'local recurrence of tumor', 'timeFrame': '2 years post radiotherapy', 'description': 'radiological or clinical evidence of disease recurrence'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Neoplasm Staging', 'Radiotherapy', 'Fiducial Markers'], 'conditions': ['Esophageal Neoplasms']}, 'descriptionModule': {'briefSummary': 'Currently, patients of suitable fitness with non-metastatic esophageal cancer are treated with surgery, radiotherapy or chemoradiotherapy. If treated with radio or chemoradiotherapy, a Computerised tomography (CT) scan is performed and is the dataset used for planning radiotherapy. Information from the endoscopic ultrasound (EUS), performed during routine staging, is used to help localize the tumor, as tumors of the esophagus are poorly visualised on CT. This information is subjective and dependant on the clinician performing the procedure. The tumor is described in relation to common anatomical landmarks. Interpretion of this information can lead to over-compensation when attempting to cover the tumor with a radiation field, to avoid a "miss". It is thought that using fiducial markers called Visicoils placed in or adjacent to the tumor\'s top and bottom extent at the time of EUS, will lead to better definition of the tumor in the planning process and hence, improvement in local tumor control, and reduction in radiotherapy dose to normal tissue.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A retrospective group of patients images without markers, will be compared to a prospective group of patients who will be imaged and treated following implantation of fiducial tumor markers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* esophageal adenocarcinoma or squamous carcinoma, or undifferentiated carcinoma.\n* No previous radiotherapy or chemotherapy.\n* Fit for radical treatment of their cancer with reasonable lung function, Fev1 \\>40%, and EUS planned.\n* ECOG Performance Status 0-1: 0 - Fully active, able to carry on all predisease performance without restriction 1 - Restricted in physically strenuous activity\n\nExclusion Criteria:\n\n* Pregnancy or breast feeding.\n* Allergy to ciprofloxacin antibiotics'}, 'identificationModule': {'nctId': 'NCT02403050', 'briefTitle': 'Feasibility Study of Fiducial Markers in Oesophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'NHS Greater Glasgow and Clyde'}, 'officialTitle': 'Feasibility Study to Assess the Benefit of Using Fiducial Markers for Patients Receiving Radiotherapy for Cancer of the Oesophagus', 'orgStudyIdInfo': {'id': 'GN14ON144'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fiducial Markers Prospective cohort', 'description': '2 fiducial markers (Visicoils) to be placed in the tumor area at the routine endoscopic ultrasound (EUS) appointment.', 'interventionNames': ['Device: Fiducial markers']}, {'label': 'Retrospective cohort', 'description': 'Images and clinical data from a retrospective group of patients without fiducial markers'}], 'interventions': [{'name': 'Fiducial markers', 'type': 'DEVICE', 'description': '2 fiducial markers (Visicoils) to be placed in the tumor area', 'armGroupLabels': ['Fiducial Markers Prospective cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G12 0YN', 'city': 'Glasgow', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Vivienne MacLaren, MBChB, MRCP', 'role': 'CONTACT', 'email': 'v.maclaren@nhs.net', 'phone': '441413017093'}], 'facility': 'Beatson Oncology Centre', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'centralContacts': [{'name': 'Vivienne MacLaren, MBChB, FRCP', 'role': 'CONTACT', 'email': 'v.maclaren@nhs.net', 'phone': '441413017093'}], 'overallOfficials': [{'name': 'Vivienne MacLaren, MBChB, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NHS Greater Glasgow & Clyde'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NHS Greater Glasgow and Clyde', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}