Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-26 @ 5:12 AM
Study NCT ID:
NCT00302094
Status:
COMPLETED
Last Update Posted:
2012-12-03
First Post:
2006-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Image Fusion PET, CT and 3D-ultrasound Examinations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001005', 'term': 'Anus Neoplasms'}], 'ancestors': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D001004', 'term': 'Anus Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-29', 'studyFirstSubmitDate': '2006-03-10', 'studyFirstSubmitQcDate': '2006-03-10', 'lastUpdatePostDateStruct': {'date': '2012-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Program to fuse 3D ultrasound and PET/CT data', 'timeFrame': 'april 2009'}]}, 'conditionsModule': {'conditions': ['Anal Cancer']}, 'descriptionModule': {'briefSummary': 'CT-examinations are used in computer programs which are used in the planning of external radiation of cancers in the anal canal. In CT the structures of the anal canal are hardly visible. 3D-ultrasound examinations offer a better visualisation of normal and pathological structures of the anal canal. The description of the tumour made from the 3D-ultrasound examination is used in the planning of the external radiation.\n\nPET-CT is used to visualise tumour activity also in lymp nodes. The hypothesis of the study is that image fusion of PET, CT and 3D-ultrasound will offer better visualisation of tumour and hereby more accurate diagnostics and treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with anal cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically verified cancer of the anal canal\n\nExclusion Criteria:\n\n* Pregnancy\n* Unability to cooperate to radiation therapy'}, 'identificationModule': {'nctId': 'NCT00302094', 'briefTitle': 'Image Fusion PET, CT and 3D-ultrasound Examinations', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Image Fusion PET, CT and 3D-ultrasound Examinations in Treatment of Anal Cancer', 'orgStudyIdInfo': {'id': '(KF) 11-107/03'}}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Clinic of Radiology, Section of Ultrasound, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Michael B Nielsen, Dmsci, phd.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rigshospitalet, Denmark'}, {'name': 'Caroline Ewertsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Caroline Ewertsen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}