Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2026-02-21 @ 8:30 AM
Study NCT ID:
NCT01731860
Status:
COMPLETED
Last Update Posted:
2016-10-04
First Post:
2012-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study Intended to Provide Input for Future Designs Using the PET Alpha Ring Detector
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-08-01', 'releaseDate': '2017-07-07'}, {'resetDate': '2017-09-18', 'releaseDate': '2017-08-21'}, {'resetDate': '2020-03-20', 'releaseDate': '2020-03-09'}, {'resetDate': '2022-03-01', 'releaseDate': '2022-02-07'}], 'estimatedResultsFirstSubmitDate': '2017-07-07'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'lastUpdateSubmitDate': '2016-09-30', 'studyFirstSubmitDate': '2012-11-09', 'studyFirstSubmitQcDate': '2012-11-21', 'lastUpdatePostDateStruct': {'date': '2016-10-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Imaging Capabilities and Performance of the Alpha Ring', 'timeFrame': 'Within 1 month of image acquisition', 'description': 'Images acquired using the investigational device will be compared with the images obtained using the approved clinical device. The qualitative image review will be performed by the reading radiologist/nuclear medicine physician.'}]}, 'conditionsModule': {'keywords': ['PET/CT', 'Philips'], 'conditions': ['Focus of Study is Imaging Performance With the New Technology Compared With the Currently Available Technology.']}, 'descriptionModule': {'briefSummary': 'A standard PET/CT scanner is comprised of two different machines: An X-ray computed tomography scanner (CT), which gives information about your anatomy, and a Positron Emission Tomography scanner (PET) that provides information about how the body functions. Both of these work together to make the final images for doctors to review. As part of this research study the investigators would like to test a new scanner technology by evaluating the quality of the images obtained using this new PET system.\n\nThe scanner the investigators would use is able to do both types of examination, the standard PET/CT and the additional research PET. The new PET system adds a second scanner ring to the standard PET/CT. This allows the patient to stay on the same imaging table for both studies. Being in this study does not change how the standard PET/CT will be done.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients are at least 18 years\n* Patients are medically stable\n* Patients scheduled for clinically necessary PET/CT examination\n\nExclusion Criteria:\n\n* Patients who are pregnant\n* Patients who are unwilling/unable to sign the Informed Consent Form\n* Patients who are cognitively impaired and unable to provide informed consent\n* Patients who have experienced adverse events to PET/CT examinations'}, 'identificationModule': {'nctId': 'NCT01731860', 'briefTitle': 'Pilot Study Intended to Provide Input for Future Designs Using the PET Alpha Ring Detector', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philips Healthcare'}, 'officialTitle': 'Pilot Study Intended to Provide Input for Future Designs Using the PET Alpha Ring Detector and to Support the Pre-market Notification of a Future Product', 'orgStudyIdInfo': {'id': 'Alpha Ring 12-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients receiving PET/CT', 'description': 'Patients already scheduled for a clinically necessary PET/CT scan.', 'interventionNames': ['Device: Additional PET Scan']}], 'interventions': [{'name': 'Additional PET Scan', 'type': 'DEVICE', 'description': 'Additional PET Scan with no additional radiopharmaceutical administration.', 'armGroupLabels': ['Patients receiving PET/CT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospital Case Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Peter F Faulhaber, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philips Healthcare', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, {'name': 'Case Western Reserve University', 'class': 'OTHER'}, {'name': 'Imarc Research, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-07-07', 'type': 'RELEASE'}, {'date': '2017-08-01', 'type': 'RESET'}, {'date': '2017-08-21', 'type': 'RELEASE'}, {'date': '2017-09-18', 'type': 'RESET'}, {'date': '2020-03-09', 'type': 'RELEASE'}, {'date': '2020-03-20', 'type': 'RESET'}, {'date': '2022-02-07', 'type': 'RELEASE'}, {'date': '2022-03-01', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Philips Healthcare'}}}}