Viewing Study NCT01084356


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Study NCT ID: NCT01084356
Status: UNKNOWN
Last Update Posted: 2010-03-10
First Post: 2010-03-09
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Evaluation of a New CZT System
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010282', 'term': 'Parathyroid Neoplasms'}, {'id': 'D013964', 'term': 'Thyroid Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'lastUpdateSubmitDate': '2010-03-09', 'studyFirstSubmitDate': '2010-03-09', 'studyFirstSubmitQcDate': '2010-03-09', 'lastUpdatePostDateStruct': {'date': '2010-03-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CZT', 'sentinel node', 'osseous processes'], 'conditions': ['Parathyroid Adenoma', 'Thyroid Adenoma']}, 'referencesModule': {'references': [{'pmid': '19339672', 'type': 'BACKGROUND', 'citation': 'Gambhir SS, Berman DS, Ziffer J, Nagler M, Sandler M, Patton J, Hutton B, Sharir T, Haim SB, Haim SB. A novel high-sensitivity rapid-acquisition single-photon cardiac imaging camera. J Nucl Med. 2009 Apr;50(4):635-43. doi: 10.2967/jnumed.108.060020.'}, {'pmid': '19020253', 'type': 'BACKGROUND', 'citation': "Hruska CB, Phillips SW, Whaley DH, Rhodes DJ, O'Connor MK. Molecular breast imaging: use of a dual-head dedicated gamma camera to detect small breast tumors. AJR Am J Roentgenol. 2008 Dec;191(6):1805-15. doi: 10.2214/AJR.07.3693."}, {'pmid': '12679406', 'type': 'BACKGROUND', 'citation': "Mueller B, O'Connor MK, Blevis I, Rhodes DJ, Smith R, Collins DA, Phillips SW. Evaluation of a small cadmium zinc telluride detector for scintimammography. J Nucl Med. 2003 Apr;44(4):602-9."}, {'pmid': '9829562', 'type': 'BACKGROUND', 'citation': 'Ketchum LE. New equipment in nuclear medicine, part 1: solid-state detectors. J Nucl Med. 1998 Nov;39(11):15N, 35N-36N. No abstract available.'}, {'pmid': '15667025', 'type': 'BACKGROUND', 'citation': "Rhodes DJ, O'Connor MK, Phillips SW, Smith RL, Collins DA. Molecular breast imaging: a new technique using technetium Tc 99m scintimammography to detect small tumors of the breast. Mayo Clin Proc. 2005 Jan;80(1):24-30. doi: 10.1016/S0025-6196(11)62953-4."}, {'pmid': '17214787', 'type': 'BACKGROUND', 'citation': "O'Connor MK, Phillips SW, Hruska CB, Rhodes DJ, Collins DA. Molecular breast imaging: advantages and limitations of a scintimammographic technique in patients with small breast tumors. Breast J. 2007 Jan-Feb;13(1):3-11. doi: 10.1111/j.1524-4741.2006.00356.x."}, {'pmid': '18483107', 'type': 'BACKGROUND', 'citation': 'Tsuchimochi M, Hayama K, Oda T, Togashi M, Sakahara H. Evaluation of the efficacy of a small CdTe gamma-camera for sentinel lymph node biopsy. J Nucl Med. 2008 Jun;49(6):956-62. doi: 10.2967/jnumed.108.050740. Epub 2008 May 15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to check if the new CZT system has an advantage in detection of small osseous processes, thyroid adenomas, parathyroid adenomas and detection of sentinel node, in comparison with the techniques in use.\n\nParticipants: 100 subjects male and female that come to the institute of nuclear medicine for routine screening examinations.\n\nThe CZT screening takes 10 minutes and does not require any extra intervention to the routine screening.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'consequtive patiants admitted for the above scans and consented to be further investigated by the CZT system', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age over 18\n\nExclusion Criteria:\n\n* pregnancy\n* patients unable to understand and sign an informed consent\n* age under 18'}, 'identificationModule': {'nctId': 'NCT01084356', 'briefTitle': 'Evaluation of a New CZT System', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'officialTitle': 'Evaluation of a New CZT System for Imaging in Routine Nuclear Medicine Examination', 'orgStudyIdInfo': {'id': 'TASMC-10-EES-0649-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'hand', 'description': 'patients admitted for Tc MDP for evaluation of carpal/metacarpal and finger bone lesions'}, {'label': 'thyroid', 'description': 'patients admitted for Tc thyroid scan'}, {'label': 'parathyroid', 'description': 'patients investigated for parathyroid adenoma'}, {'label': 'sentinel node', 'description': 'patients who are due to sentinel node biopsy'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'country': 'Israel', 'contacts': [{'name': 'Einat Even Sapir, PhD, MD', 'role': 'CONTACT', 'email': 'evensap@tasmc.health.gov.il', 'phone': '972-3-6974444', 'phoneExt': '3536'}, {'name': 'Ayelet Kurzband, BA', 'role': 'CONTACT', 'email': 'ayeletk@tasmc.health.gov.il', 'phone': '972-3-6974444', 'phoneExt': '3536'}, {'name': 'Hedva Lerman, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Einat Even-Sapir, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Nuclear Medicine, Tel Aviv Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'centralContacts': [{'name': 'Einat Even Sapir, PhD,MD', 'role': 'CONTACT', 'email': 'evensap@tasmc.health.gov.il', 'phone': '972-3-6974444', 'phoneExt': '3536'}, {'name': 'Ayelet Kurzband, BA', 'role': 'CONTACT', 'email': 'ayeletk@tasmc.health.gov.il', 'phone': '972-3-6974444', 'phoneExt': '3536'}], 'overallOfficials': [{'name': 'Einat Even Sapir, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tel Aviv Sourasky Medical Center, Tel Aviv, Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Einat Even-Sapir MD, PhD. Head, Dept of Nuclear Medicine', 'oldOrganization': 'Tel Aviv SoUrasky medical center'}}}}