Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-01-03 @ 8:26 AM
Study NCT ID:
NCT03112356
Status:
UNKNOWN
Last Update Posted:
2017-06-20
First Post:
2017-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Value of 99mTc-Leukoscan® Scintigraphy in the Diagnosis of Infectious Endocarditis on Surgical Materials
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004696', 'term': 'Endocarditis'}, {'id': 'D004698', 'term': 'Endocarditis, Subacute Bacterial'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D004697', 'term': 'Endocarditis, Bacterial'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D053821', 'term': 'Cardiovascular Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2018-10-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-19', 'studyFirstSubmitDate': '2017-03-24', 'studyFirstSubmitQcDate': '2017-04-07', 'lastUpdatePostDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence or not of infectious endocarditis on surgical materials', 'timeFrame': '3 months (plus or minus 1 month)', 'description': "The presence or not of infectious endocarditis on surgical materials will be measured using Duke's criteria of patients follow-up at 3 months (plus or minus 1 month)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['infectious endocarditis', 'prosthetic valve infection', 'implantable cardiac device infection', '99mTc-Leukoscan® scintigraphy'], 'conditions': ['Endocarditis']}, 'descriptionModule': {'briefSummary': 'Infectious endocarditis is a serious pathology with difficult diagnosis especially on prosthetic valves or cardiac device because of the plurality of clinical presentations and the low sensitivity value of echocardiography in these patients. Despite a well validated indication for the detection of septic emboli, the value of FDG-PET for the detection of prosthetic valves or cardiac implantable device is still unclear especially because of frequent non-septic inflammatory processes.\n\nTo improve the specificity value, the use of radio-labeled leukocytes scintigraphy is conventionally proposed. An alternative method is to label leukocytes in vivo with an anti-murin anti body fragment ( Sulesomab , Leukoscan®). This scintigraphy is regularly used in the investigation of osteomyelitis and has been proposed in infectious endocarditis. To knowledge of investigators, the value of Leukoscan® scintigraphy on prosthetic valve or cardiac device infection had not been studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects aged \\> 21 years\n* Patients presenting a suspicions of infectious endocarditis on surgical materials\n* Written informed consent\n\nExclusion Criteria:\n\n* Patient with a history of exposure to murine antigens, particularly a patient who has already received a 99mTc-Leukoscan® scintigraphy\n* Patients whose clinical condition requires prompt care, not allowing them to wait for the examination\n* Pregnant or nursing (including pumping for storage and feeding)\n* Patients under adapted antibiotic therapy for more than 15 days\n* Deprivation of civil rights (curatorship, guardianship, safeguard of justice)'}, 'identificationModule': {'nctId': 'NCT03112356', 'acronym': 'PLEIM', 'briefTitle': 'The Value of 99mTc-Leukoscan® Scintigraphy in the Diagnosis of Infectious Endocarditis on Surgical Materials', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'The Value of 99mTc-Leukoscan® Scintigraphy in the Diagnosis of Infectious Endocarditis on Surgical Materials', 'orgStudyIdInfo': {'id': '69HCL16_0728'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '99mTc-Leukoscan® scintigraphy', 'description': 'Patients presenting a suspicions of infectious endocarditis on surgical materials and undergoing the 99mTc-Leukoscan® scintigraphy', 'interventionNames': ['Drug: 99mTc-Leukoscan® scintigraphy']}], 'interventions': [{'name': '99mTc-Leukoscan® scintigraphy', 'type': 'DRUG', 'description': 'Gated single photon emission computed tomography with co-registered computer tomography (gated SPECT-CT) 6 hours and 24 hours after infusion of 99mTc-Leukoscan (1000 MBq)', 'armGroupLabels': ['99mTc-Leukoscan® scintigraphy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69500', 'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bastien GREGOIRE, MD', 'role': 'CONTACT', 'email': 'bastien.gregoire@chu-lyon.fr', 'phone': '472357629', 'phoneExt': '+33'}, {'name': 'Nawele BOUBLAY', 'role': 'CONTACT', 'email': 'nawele.boublay@chu-lyon.fr', 'phone': '427856302', 'phoneExt': '+33'}, {'name': 'Bastien GREGOIRE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'François DELAHAYE, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Caroline MOREAU, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Géraldine PINAJOMIR, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}], 'centralContacts': [{'name': 'Bastien GREGOIRE, MD', 'role': 'CONTACT', 'email': 'bastien.gregoire@chu-lyon.fr', 'phone': '472357629', 'phoneExt': '+33'}, {'name': 'Nawele BOUBLAY', 'role': 'CONTACT', 'email': 'nawele.boublay@chu-lyon.fr', 'phone': '427856302', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Bastien GREGOIRE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}