Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2026-01-10 @ 8:54 PM
Study NCT ID:
NCT01701167
Status:
UNKNOWN
Last Update Posted:
2012-10-04
First Post:
2012-10-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Verification of the Quantitative Accuracy of the PET/CT System Imaging Chain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'lastUpdateSubmitDate': '2012-10-02', 'studyFirstSubmitDate': '2012-10-02', 'studyFirstSubmitQcDate': '2012-10-02', 'lastUpdatePostDateStruct': {'date': '2012-10-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Confirm PCA-9000A PET/CT System is Effective for Its Intended Use']}, 'descriptionModule': {'briefSummary': 'The purpose of this study will evaluate new technologies that have been included in the new PCA-9000A PET/CT System.', 'detailedDescription': 'Scope:\n\nTo evaluate the new technologies that have been included in the PCA-9000A PET/CT System, the study has the following 3 goals.\n\n* Define and confirm all supported clinical protocols from Low-Dose CT, to PET acquisition and presentation.\n* Verification of the quantitative accuracy of the imaging chain.\n* Evaluate the performance and stability of the new system and its related quality control and calibration procedures.\n\nResult (Expected):\n\nThe study is an essential step in assessing the quality of the hardware and software defining the new PCA-9000A PET/CT System. Several essential parameters for the acquisition, reconstruction, correction, filtering, and presentation will be estimated or adjusted during this period. The evaluation will confirm PCA-9000A PET/CT System is effective for its intended use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients already scheduled for a FDG test.', 'eligibilityCriteria': 'Inclusion:\n\n* Patients already scheduled for an FDG test at SDMI\n* 40 years and older\n* Adult must be able to sign an informed consent form\n\nExclusion\n\n* Patients not scheduled for an FDG test at SDMI\n* 39 years or younger\n* Pregnant adult female or plan to be pregnant\n* Adult who is unable to sign the informed consent'}, 'identificationModule': {'nctId': 'NCT01701167', 'briefTitle': 'Verification of the Quantitative Accuracy of the PET/CT System Imaging Chain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Toshiba America Medical Systems, Inc.'}, 'officialTitle': 'ROMAN (PCA-9000A) PET/CT System Verification', 'orgStudyIdInfo': {'id': 'ROMAN-01'}}, 'contactsLocationsModule': {'locations': [{'zip': '89052', 'city': 'Henderson', 'state': 'Nevada', 'country': 'United States', 'contacts': [{'name': 'Jim Kelley', 'role': 'CONTACT', 'phone': '702-240-1215'}, {'name': 'Mark L Winkler, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Steinberg Diagnostic Medical Imaging Centers', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Toshiba America Medical Systems, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}