Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-25 @ 7:39 PM
Study NCT ID:
NCT00162032
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2005-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Use and Safety of CARDIOLITE® in Pediatric Patients With Kawasaki Disease
Sponsor:
Organization:
Raw JSON
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SAEs up to 14 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Children (Ages 4-11)', 'description': 'Arm A children 4-11 years of age', 'otherNumAtRisk': 329, 'otherNumAffected': 8, 'seriousNumAtRisk': 329, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Adolescents (Ages 12-16)', 'description': 'Arm B adolescents 12-16 years of age', 'otherNumAtRisk': 116, 'otherNumAffected': 5, 'seriousNumAtRisk': 116, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Overdose', 'notes': 'Subject 014-006 was a 5-year old white female. The subject received a total dose of Cardiolite on 05 June 2006 of 16.9 mCi. The nuclear medicine technician incorrectly calculated the doses based on a weight of 40 kg rather 40 lbs (18.1 kg).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Determine the Predictive Value of Cardiolite® Rest and Stress MPI to Define Pediatric Populations With Kawasaki Disease at High and Low Risk of Developing Cardiac Events.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Children (4 -11 Years) Normal', 'description': 'SSS (summed stress score) \\<=4, low risk'}, {'id': 'OG001', 'title': 'Adolescents (12-16 Years) Normal', 'description': 'SSS (summed stress score) \\<4, low risk'}, {'id': 'OG002', 'title': 'Children (4-11 Years) Abnormal', 'description': 'SSS (summed stress score)\\>4, high risk'}, {'id': 'OG003', 'title': 'Adolescents (12-16 Years) Abnormal', 'description': 'sss (summed stress score \\>4, high risk'}], 'classes': [{'categories': [{'measurements': [{'value': '0.041', 'groupId': 'OG000', 'lowerLimit': '0.015', 'upperLimit': '0.066'}, {'value': '0.033', 'groupId': 'OG001', 'lowerLimit': '0.000', 'upperLimit': '0.071'}, {'value': '0.115', 'groupId': 'OG002', 'lowerLimit': '0.000', 'upperLimit': '0.238'}, {'value': '0.233', 'groupId': 'OG003', 'lowerLimit': '0.000', 'upperLimit': '0.493'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'The proportion of all patients who experienced cardiac events among patients with abnormal (SSS \\>=4, high risk) and normal (SSS \\<4, low risk) Cardiolite MPI scans during the follow-up period. A log-rank statistic (2-sided, alpha = 0.05) was computed to compare cardiac event-free survival in the high risk and low risk groups. The cardiac event rate is the cumulative event rate based on a Kaplan-Meier estimate conditional on the SPECT MPI score result.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Had SPECT Myocardial perfusion imaging tests and experienced a cardiac event'}, {'type': 'SECONDARY', 'title': 'Estimate the Performance of Cardiolite® Rest and Stress MPI for the Detection of Myocardial Ischemia in Adolescents and Children Versus Coronary Angiography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Angiography Subjects', 'description': 'Subset of pooled adolescent and child subjects who underwent coronary angiography'}], 'classes': [{'title': 'Sensitivity', 'categories': [{'measurements': [{'value': '0.35', 'groupId': 'OG000', 'lowerLimit': '0.11', 'upperLimit': '0.69'}]}]}, {'title': 'Specificity', 'categories': [{'measurements': [{'value': '0.62', 'groupId': 'OG000', 'lowerLimit': '0.45', 'upperLimit': '0.77'}]}]}, {'title': 'Positive Predictive Value', 'categories': [{'measurements': [{'value': '0.21', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '0.46'}]}]}, {'title': 'Negative Predictive Value', 'categories': [{'measurements': [{'value': '0.77', 'groupId': 'OG000', 'lowerLimit': '0.59', 'upperLimit': '0.90'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of myocardial perfusion imaging (MPI) for the diagnosis of ischemic heart disease (IHD) relative to coronary angiography. Coronary stenoses of ≥ 50% were classified as disease. SSS \\> 4 in MPI was classified as positive for IHD.', 'unitOfMeasure': 'proportion', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population of pooled adolescents and children who underwent coronary angiography'}, {'type': 'SECONDARY', 'title': 'Incidence of Hard Cardiac Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Children (4 -11 Years) Normal', 'description': 'SSS (summed stress score) \\<=4, low risk'}, {'id': 'OG001', 'title': 'Adolescents (12-16 Years) Normal', 'description': 'SSS (summed stress score) \\<4, low risk'}, {'id': 'OG002', 'title': 'Children (4-11 Years) Abnormal', 'description': 'SSS (summed stress score)\\>4, high risk'}, {'id': 'OG003', 'title': 'Adolescents (12-16 Years) Abnormal', 'description': 'sss (summed stress score \\>4, high risk'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'Examine the incidence of hard cardiac events (myocardial infarction \\[MI\\] or cardiac death) in KD subjects with positive and negative MPI scans.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who had undergone stress cardiac MPI studies'}, {'type': 'SECONDARY', 'title': 'Estimate the Performance of Cardiolite® Rest and Stress MPI for the Detection of Myocardial Ischemia in the Left Anterior Descending (LAD) Artery in Adolescents and Children Versus Coronary Angiography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Children (Ages 4-11)', 'description': 'Arm A children 4-11 years of age who underwent coronary angiography'}, {'id': 'OG001', 'title': 'Adolescents (Ages 12-16)', 'description': 'Arm B adolescents 12-16 years of age who underwent coronary angiography'}], 'classes': [{'title': 'Sensitivity', 'categories': [{'measurements': [{'value': '.25', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.81'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.71'}]}]}, {'title': 'Specificity', 'categories': [{'measurements': [{'value': '0.76', 'groupId': 'OG000', 'lowerLimit': '0.55', 'upperLimit': '0.91'}, {'value': '0.74', 'groupId': 'OG001', 'lowerLimit': '0.49', 'upperLimit': '0.91'}]}]}, {'title': 'Positive Predictive Value', 'categories': [{'measurements': [{'value': '0.14', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.58'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.52'}]}]}, {'title': 'Negative Predictive Value', 'categories': [{'measurements': [{'value': '0.86', 'groupId': 'OG000', 'lowerLimit': '0.65', 'upperLimit': '0.97'}, {'value': '0.82', 'groupId': 'OG001', 'lowerLimit': '0.57', 'upperLimit': '0.96'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 hours', 'description': 'Sensitivity, specificity, PPV, and NPV of SDS for myocardial perfusion corresponding to the left anterior descending (LAD) for the diagnosis of IHD in the distribution of the left anterior descending (LAD) artery relative to coronary angiography based diagnosis were determined. Coronary stenoses of ≥ 50% for arteries associated with LAD territories were classified as LAD disease. SDS LAD \\> 1 was classified as positive for IHD for the LAD distribution.', 'unitOfMeasure': 'proportion', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Predictive Value of Cardiolite For Cardiac Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Children (4 -11 Years) Normal', 'description': 'SSS (summed stress score) \\<=4, low risk'}, {'id': 'OG001', 'title': 'Adolescents (12-16 Years) Normal', 'description': 'SSS (summed stress score) \\<4, low risk'}, {'id': 'OG002', 'title': 'Children (4-11 Years) Abnormal', 'description': 'SSS (summed stress score)\\>4, high risk'}, {'id': 'OG003', 'title': 'Adolescents (12-16 Years) Abnormal', 'description': 'sss (summed stress score \\>4, high risk'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Determine the incidence of cardiac events occurring over a 6 month follow up period in pediatric subjects with normal myocardial perfusion scans.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Evaluable Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Children (Ages 4-11)', 'description': 'Arm A children 4-11 years of age'}, {'id': 'FG001', 'title': 'Adolescents (Ages 12-16)', 'description': 'Arm B children 12-16 years of age'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '329'}, {'groupId': 'FG001', 'numSubjects': '116'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed is all subjects who completed 3 yr FU whether or not they were seen in the previous year.', 'groupId': 'FG000', 'numSubjects': '324'}, {'comment': 'Completed is all subjects who completed 3 yr FU whether or not they were seen in the previous year.', 'groupId': 'FG001', 'numSubjects': '114'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Reason not specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '445', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Children (Ages 4-11)', 'description': 'Arm A children 4-11 years of age'}, {'id': 'BG001', 'title': 'Adolescents (Ages 12-16)', 'description': 'Arm B children 12-16 years of age'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '329', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '445', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'spread': '2.16', 'groupId': 'BG000'}, {'value': '13.6', 'spread': '1.31', 'groupId': 'BG001'}, {'value': '9.0', 'spread': '3.27', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '225', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '301', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}, {'title': 'Philippines', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': 'Taiwan', 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}, {'title': 'Thailand', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}, {'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}, {'title': 'Singapore', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 445}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-02', 'studyFirstSubmitDate': '2005-09-09', 'resultsFirstSubmitDate': '2013-04-30', 'studyFirstSubmitQcDate': '2005-09-09', 'lastUpdatePostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-10-08', 'studyFirstPostDateStruct': {'date': '2005-09-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the Predictive Value of Cardiolite® Rest and Stress MPI to Define Pediatric Populations With Kawasaki Disease at High and Low Risk of Developing Cardiac Events.', 'timeFrame': '3 years', 'description': 'The proportion of all patients who experienced cardiac events among patients with abnormal (SSS \\>=4, high risk) and normal (SSS \\<4, low risk) Cardiolite MPI scans during the follow-up period. A log-rank statistic (2-sided, alpha = 0.05) was computed to compare cardiac event-free survival in the high risk and low risk groups. The cardiac event rate is the cumulative event rate based on a Kaplan-Meier estimate conditional on the SPECT MPI score result.'}], 'secondaryOutcomes': [{'measure': 'Estimate the Performance of Cardiolite® Rest and Stress MPI for the Detection of Myocardial Ischemia in Adolescents and Children Versus Coronary Angiography', 'timeFrame': '6 months', 'description': 'Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of myocardial perfusion imaging (MPI) for the diagnosis of ischemic heart disease (IHD) relative to coronary angiography. Coronary stenoses of ≥ 50% were classified as disease. SSS \\> 4 in MPI was classified as positive for IHD.'}, {'measure': 'Incidence of Hard Cardiac Events', 'timeFrame': '3 years', 'description': 'Examine the incidence of hard cardiac events (myocardial infarction \\[MI\\] or cardiac death) in KD subjects with positive and negative MPI scans.'}, {'measure': 'Estimate the Performance of Cardiolite® Rest and Stress MPI for the Detection of Myocardial Ischemia in the Left Anterior Descending (LAD) Artery in Adolescents and Children Versus Coronary Angiography', 'timeFrame': '24 hours', 'description': 'Sensitivity, specificity, PPV, and NPV of SDS for myocardial perfusion corresponding to the left anterior descending (LAD) for the diagnosis of IHD in the distribution of the left anterior descending (LAD) artery relative to coronary angiography based diagnosis were determined. Coronary stenoses of ≥ 50% for arteries associated with LAD territories were classified as LAD disease. SDS LAD \\> 1 was classified as positive for IHD for the LAD distribution.'}, {'measure': 'Predictive Value of Cardiolite For Cardiac Events', 'timeFrame': '6 months', 'description': 'Determine the incidence of cardiac events occurring over a 6 month follow up period in pediatric subjects with normal myocardial perfusion scans.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Kawasaki Disease']}, 'descriptionModule': {'briefSummary': 'Determine the predictive value of CARDIOLITE® rest and stress myocardial perfusion imaging (MPI) to define a pediatric population with Kawasaki Disease (KD) at high and low risk of developing cardiac events.', 'detailedDescription': 'The purpose of this clinical research study is to determine how well CARDIOLITE® rest and stress myocardial (heart) imaging can define the pediatric Kawasaki disease (KD) population into high and low risk categories of developing cardiac (heart) events (complications) from 1 year through 3 years after image completion. The safety of CARDIOLITE® rest and stress heart imaging will also be studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females between 4 and 16\n* Meet the epidemiological definition of Kawasaki Disease or have a diagnosis of incomplete KD, including evidence of coronary artery disease as determined by their physician.\n* Be able to exercise adequately to achieve 85% age predicted maximum heart rate\n\nExclusion Criteria:\n\n* Terminal illness where expected survival is \\< 6 months'}, 'identificationModule': {'nctId': 'NCT00162032', 'briefTitle': 'A Study to Evaluate the Use and Safety of CARDIOLITE® in Pediatric Patients With Kawasaki Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lantheus Medical Imaging'}, 'officialTitle': 'A Phase III, Open-Label, Non-Randomized, International, Multicenter Trial to Evaluate the Efficacy and Safety of CARDIOLITE® Myocardial Perfusion Imaging in Pediatric Subjects With Kawasaki Disease', 'orgStudyIdInfo': {'id': 'CARDIOLITE® 301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Children (Ages 4-11)', 'description': 'Children 4-11 years of age, intervention Sestamibi', 'interventionNames': ['Drug: Sestamibi']}, {'type': 'OTHER', 'label': 'Adolescents (Ages 12-16)', 'description': 'Adolescents 12-16 years of age, intervention Sestamibi', 'interventionNames': ['Drug: Sestamibi']}], 'interventions': [{'name': 'Sestamibi', 'type': 'DRUG', 'otherNames': ['Cardiolite'], 'description': 'Sestamibi', 'armGroupLabels': ['Adolescents (Ages 12-16)', 'Children (Ages 4-11)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '06511', 'city': 'New 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