Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-01-31 @ 5:49 AM
Study NCT ID:
NCT02538133
Status:
UNKNOWN
Last Update Posted:
2019-03-07
First Post:
2015-07-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Assessing Hybrid SPECT-CT With Labeled Leukocytes for Diagnosis of Vascular Prosthesis Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-06', 'studyFirstSubmitDate': '2015-07-30', 'studyFirstSubmitQcDate': '2015-08-28', 'lastUpdatePostDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients correctly classified by interpreting scintigraphy for the diagnosis of vascular prosthesis infection. The percentage of patients correctly classified is assessed comparing with the diagnostic established by the expert committee.', 'timeFrame': 'One year after inclusion when vascular prosthesis infection is suspected and hybrid SPEC-CT with labeled leukocytes has been performed.', 'description': 'A visual analysis of scintigraphy for diagnosing vascular prosthesis infection. Scintigraphy is considered positive if at least one abnormal localization is seen at vascular prosthesis and if intensity is increasing over time on 20-24h delayed images.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['99mTc-Exametazime (HMPAO)-Labeled Leukocytes', 'suspected subdiaphragmatic vascular prosthesis infection', 'diagnosis'], 'conditions': ['Vascular Prosthesis Infection']}, 'descriptionModule': {'briefSummary': "Vascular Prothesis Infection is a rare but an extremely serious complication. Diagnosis is often difficult (germs are found only in 50% of cases). Conventional imagery is often non-specific and difficult to interpret especially in early postoperative phase. Leukocytes isolated from the patient's blood are labeled with a radiopharmaceutical technetium 99mTc-HMPAO.\n\nThe aim of this study is to assess the overall diagnostic performance of scintigraphy (hybrid SPEC-CT) with labeled leucocytes in diagnosis of subdiaphragmatic vascular prothesis infection."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient of more than 18 years old\n* Patient with a subdiaphragmatic vascular prosthesis\n* Vascular prosthesis infection suspected with clinical (flow from the scare and/or local pain and/or erythema and/or persistent fever and/or bacteraemia) and/or biological (inflammatory syndrome : elevated C-reactive protein and/or erythrocyte sedimentation rate (ESR) and/or white blood cells increased) infection signs\n* Patient willing to participate with a signed informed consent\n* Patient covered by a healthcare insurance\n\nExclusion Criteria:\n\n* Pregnant women or of childbearing age without effective contraception\n* Prosthesis limited to a bare stent.\n* Patient who has been committed to an institution by legal or regulatory order\n* Contraindications for labeled leukocytes scintigraphy realization :\n* Restlessness, inability to keep still lie at least 1 hour\n* Claustrophobia\n* Poor compliance predictable or impaired general condition making it impossible to carry out the examination\n* Refusal to participate in the study'}, 'identificationModule': {'nctId': 'NCT02538133', 'acronym': 'LEUCOPRO', 'briefTitle': 'Study Assessing Hybrid SPECT-CT With Labeled Leukocytes for Diagnosis of Vascular Prosthesis Infections', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'Tomoscintigraphie Hybride Aux Leucocytes Marqués Dans le Diagnostic Des Infections de Prothèses Vasculaires.', 'orgStudyIdInfo': {'id': '49RC14_0072'}, 'secondaryIdInfos': [{'id': '2015-001342-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '99mTc-Exametazime (HMPAO)-labeled leucocytes', 'interventionNames': ['Biological: 99mTc-Exametazime (HMPAO)-labeled leukocytes']}], 'interventions': [{'name': '99mTc-Exametazime (HMPAO)-labeled leukocytes', 'type': 'BIOLOGICAL', 'description': 'Hybrid tomoscintigraphy with labeled leucocytes for patients with suspected vascular prosthesis infection', 'armGroupLabels': ['99mTc-Exametazime (HMPAO)-labeled leucocytes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49933', 'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Hervé Rakotonirina', 'role': 'CONTACT'}, {'name': 'Hervé Rakotonirina', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Valérie Rabier', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jean Picquet', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '72037', 'city': 'Le Mans', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Helene Loubiere', 'role': 'CONTACT'}, {'name': 'Hélène Loubière', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hikombo Hitoto', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mammar Hachemi', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CH', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nabil Chakfe', 'role': 'CONTACT'}, {'name': 'Nabil Chakfe', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Daniel Christmann', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Céline Heimburger', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Cyrille Blondet', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yves Hansmann', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Fabien Thaveau', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mathieu Roussin', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHRU', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'HERVE RAKOTONIRINA, Dr', 'role': 'CONTACT', 'email': 'HeRakotonirina@chu-angers.fr', 'phone': '+33(0)241353412'}], 'overallOfficials': [{'name': 'HERVE RAKOTONIRINA, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University hospital, Angers, FRANCE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}