Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-04-01 @ 12:54 PM
Study NCT ID:
NCT00382967
Status:
COMPLETED
Last Update Posted:
2012-09-03
First Post:
2006-09-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess Changes in Clinical Management After DaTSCAN Imaging of Subjects With Clinically Uncertain Parkinsonism or an Illness With Similar Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D009069', 'term': 'Movement Disorders'}], 'ancestors': [{'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'igor.grachev@ge.com', 'phone': '1-609-514-6857', 'title': 'Igor Grachev, MD', 'organization': 'GE Healthcare'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Datscan Product', 'description': '\\[Iodine-123\\]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) \\[3-5 millicurie (mCi)\\].', 'otherNumAtRisk': 122, 'otherNumAffected': 0, 'seriousNumAtRisk': 122, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Arm', 'description': 'No (Injection) Intervention', 'otherNumAtRisk': 137, 'otherNumAffected': 0, 'seriousNumAtRisk': 137, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Datscan Product', 'description': '\\[Iodine-123\\]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) \\[3-5 millicurie (mCi)\\].'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'No (Injection) Intervention'}], 'classes': [{'title': 'Initiation of medication not planned', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Avoidance/withdrawal of medication planned', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Performance of diagnostic test not planned', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Avoidance of diagnostic test planned', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Arrangement of a referral not planned', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Cancellation of a referral planned', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Other Actions', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Significant changes made', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Changes in clinical management made from Visit 1 (baseline) to Visit 3 (a 3 month period)', 'description': "The impact the Datscan image had on the Doctor's decisions on the clinical management of subjects. A record of the number of changes in the Doctor's clinical management. It is possible for a subject to have multiple changes in Clinical management and other subjects to have no change in their management.", 'unitOfMeasure': 'Number of changes in clinical management', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Datscan Product', 'description': '\\[Iodine-123\\]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) \\[3-5 millicurie (mCi)\\].'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'No (Injection) Intervention'}], 'classes': [{'title': 'Initiation of Medication not planned', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Avoidance or withdrawal of medication planned', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Performance of diagnostic test not planned', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Avoidance of diagnostic test planned', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Arrangement of referral not planned', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Cancellation of referral planned', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Other Actions', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Significant changes made', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the first patient Visit 1 (1 month) to Visit 4 (12 months). This goes from the baseline (visit 1) up to 1 year post contrast administration.', 'description': "The impact the Datscan image had on the Doctor's decisions on the clinical management of subjects. A record of the number of changes in the Doctor's clinical management. From the first patient visit (baseline) to the fourth patient visit, which was 12 months. This was a 1 year time period being assessed.It is possible for a subject to have multiple changes in Clinical management and other subjects to have no change in their management.", 'unitOfMeasure': 'Number of changes in clinical management', 'reportingStatus': 'POSTED', 'populationDescription': 'The numbers represent the number of changes in decisions that the Doctor made in the clinical management of the patient with Clinically Uncertain Parkinsonism'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Datscan Product', 'description': '\\[Iodine-123\\]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) \\[3-5 millicurie (mCi)\\].'}, {'id': 'FG001', 'title': 'Control Arm', 'description': 'No (Injection) Intervention'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '135 subjects enrolled at the start of the study, however, 13 subjects withdrew prior to dosing.', 'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '138'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Patient lost to followup and the data was not recorded.', 'groupId': 'FG000', 'numSubjects': '121'}, {'comment': 'Subject dosed in error, should not have received Datscan product', 'groupId': 'FG001', 'numSubjects': '137'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '258', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Datscan Product', 'description': '\\[Iodine-123\\]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) \\[3-5 millicurie (mCi)\\].'}, {'id': 'BG001', 'title': 'Control Arm', 'description': 'No (Injection) Intervention'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.9', 'spread': '12.1', 'groupId': 'BG000'}, {'value': '65.5', 'spread': '11.8', 'groupId': 'BG001'}, {'value': '66.2', 'spread': '11.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Norway', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 273}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-29', 'studyFirstSubmitDate': '2006-09-29', 'resultsFirstSubmitDate': '2012-05-14', 'studyFirstSubmitQcDate': '2006-09-29', 'lastUpdatePostDateStruct': {'date': '2012-09-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-07-26', 'studyFirstPostDateStruct': {'date': '2006-10-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.', 'timeFrame': 'Changes in clinical management made from Visit 1 (baseline) to Visit 3 (a 3 month period)', 'description': "The impact the Datscan image had on the Doctor's decisions on the clinical management of subjects. A record of the number of changes in the Doctor's clinical management. It is possible for a subject to have multiple changes in Clinical management and other subjects to have no change in their management."}], 'secondaryOutcomes': [{'measure': 'Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.', 'timeFrame': 'From the first patient Visit 1 (1 month) to Visit 4 (12 months). This goes from the baseline (visit 1) up to 1 year post contrast administration.', 'description': "The impact the Datscan image had on the Doctor's decisions on the clinical management of subjects. A record of the number of changes in the Doctor's clinical management. From the first patient visit (baseline) to the fourth patient visit, which was 12 months. This was a 1 year time period being assessed.It is possible for a subject to have multiple changes in Clinical management and other subjects to have no change in their management."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Parkinsonian Syndromes, Parkinsonism, DaTSCAN, SPECT, clinical management, quality of life, movement disorder', 'Clinically uncertain Parkinsonian Syndromes'], 'conditions': ['Parkinsonian Syndromes']}, 'referencesModule': {'references': [{'pmid': '22492213', 'type': 'DERIVED', 'citation': 'Kupsch AR, Bajaj N, Weiland F, Tartaglione A, Klutmann S, Buitendyk M, Sherwin P, Tate A, Grachev ID. Impact of DaTscan SPECT imaging on clinical management, diagnosis, confidence of diagnosis, quality of life, health resource use and safety in patients with clinically uncertain parkinsonian syndromes: a prospective 1-year follow-up of an open-label controlled study. J Neurol Neurosurg Psychiatry. 2012 Jun;83(6):620-8. doi: 10.1136/jnnp-2011-301695. Epub 2012 Apr 6.'}]}, 'descriptionModule': {'briefSummary': 'Patients come to their doctor showing possible symptoms of a movement disorder. It is possible that these symptoms may get worse over time. There is more than one disease that can cause such symptoms. The most common movement disorder illnesses are Parkinson´s Disease and Essential Tremor. Sometimes it is difficult for doctors to make the right diagnosis because the symptoms caused by these illnesses are almost the same. On the other hand the correct treatment for Parkinson´s Disease is different from the correct treatment for Essential Tremor. This study aims to see whether having pictures of the brain taken with DaTSCAN can affect the way the doctor treats these patients and whether it can affect their quality of life directly.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with clinically uncertain Parkinsonian Syndromes or monosymptomatic, atypical or incomplete presentation of tremor, rigidity, bradykinesia or postural instability.\n* Onset of clinical manifestations within the last 5 years\n\nExclusion Criteria:\n\n* Differential diagnosis between Parkinsons´s Disease and Progressive Supranuclear Palsy or between Parkinson´s Disease and Multiple System Atrophy\n* Subjects with an established/certain movement disorder clinical diagnosis\n* Presence of known causes of tremor'}, 'identificationModule': {'nctId': 'NCT00382967', 'briefTitle': 'A Study to Assess Changes in Clinical Management After DaTSCAN Imaging of Subjects With Clinically Uncertain Parkinsonism or an Illness With Similar Symptoms', 'organization': {'class': 'INDUSTRY', 'fullName': 'GE Healthcare'}, 'officialTitle': 'A Multicentre, Randomised, Open Label, Comparative Phase 4 Trial to Assess Changes in Clinical Management After DaTSCAN Imaging of Subjects With Clinically Uncertain Parkinsonism in a General Neurologist Setting.', 'orgStudyIdInfo': {'id': 'PDT409'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Datscan Product', 'interventionNames': ['Procedure: DaTSCAN SPECT imaging']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'DaTSCAN SPECT imaging', 'type': 'PROCEDURE', 'otherNames': ['I-123 Ioflupane'], 'description': 'A single intravenous injection of DaTSCAN with a total activity of 111-185 MBq (volume of 2.5 or 5.0 mL). SPECT scanning to be performed 3 to 6 hours after DaTSCAN injection.', 'armGroupLabels': ['Datscan Product']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08540', 'city': 'Princeton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'GE Healthcare', 'geoPoint': {'lat': 40.34872, 'lon': -74.65905}}, {'zip': '78457', 'city': 'Vélizy-Villacoublay', 'country': 'France', 'facility': 'GE Healthcare', 'geoPoint': {'lat': 48.78198, 'lon': 2.19395}}], 'overallOfficials': [{'name': 'Prof. Dr. Andreas Kupsch', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virchov Klinikum, Berlin, Germany'}, {'name': 'Paul Sherwin, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GE Healthcare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GE Healthcare', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'i3 Statprobe', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}