Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-02-18 @ 8:28 AM
Study NCT ID:
NCT03991156
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-14
First Post:
2019-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AVATAR Anesthesia Alternative in Pediatric Radiotherapy: A Multi-Center Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2019-06-12', 'studyFirstSubmitQcDate': '2019-06-17', 'lastUpdatePostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate of AVATAR system', 'timeFrame': '24 months', 'description': 'Success rate will be determined as the proportion of patients who are successes.\n\nSuccess will be counted as each patient who is able to undergo at least one fraction without anesthesia while each patient who does not have at least one fraction without anesthesia will count as a failure.'}], 'secondaryOutcomes': [{'measure': 'Measure Fractional Success using AVATAR system', 'timeFrame': '24 months', 'description': 'Fractional Success will be is counted as a fraction in which the patient does not require anesthesia will count as a fractional success, while a fraction in which the patient required anesthesia will be a fractional failure.'}, {'measure': 'Determine the difference in patient anxiety between successful AVATAR patients and not-successful patients.', 'timeFrame': '24 months', 'description': 'The difference in patient anxiety between successful AVATAR patients and not-successful patients will be determined. Anxiety will be assesed by modified Yale Preoperative Anxiety Survey Short Form (mYPAS-SF). mYPAS-SF measurement instrument uses 5 items, each representing a different domain of child anxiety, and is used at 4 points in time.'}, {'measure': 'Compare the rates of anesthesia with historical controls', 'timeFrame': '24 months', 'description': 'Compare the rates of anesthesia use between patients using AVATAR to historical controls who were not introduced to AVATAR.'}, {'measure': 'Determine the rate at which patients convert from requiring anesthesia to not requiring anesthesia while using AVATAR', 'timeFrame': '24 months', 'description': 'The rate at which patients convert from requiring anesthesia to not requiring anesthesia while using AVATAR will be determined. Conversion is determined by the fraction at which the patient switches from using anesthesia to not using anesthesia.'}, {'measure': 'Difference in health quality of life between subjects with or without anesthesia', 'timeFrame': '24 months', 'description': 'The difference between family-reported health-related quality of life between patients who were able to tolerate treatment without anesthesia using the AVATAR program and patients who required anesthesia for the entire treatment. The quality of life will be measured using Pediatric oncology quality of life inventory 3.0-cancer module (PedsQL 3.0 Cancer Module)'}, {'measure': 'Assess predictability for AVATAR patient success', 'timeFrame': '24 months', 'description': 'AVATAR patient success will be determined by using the predictability of the PedsQL3.0 Cancer and modified Yale Preoperative Assessment Survey Short Form (mYPAS-SF) questionnaires. mYPAS-SF measurement instrument uses 5 items, each representing a different domain of child anxiety, and is used at 4 points in time.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Radiotherapy'], 'conditions': ['Anesthesia']}, 'referencesModule': {'references': [{'pmid': '37001762', 'type': 'DERIVED', 'citation': 'Gutkin PM, Skinner L, Jiang A, Donaldson SS, Loo BW Jr, Oh J, Wang YP, von Eyben R, Snyder J, Bredfeldt JS, Breneman JC, Constine LS, Faught AM, Haas-Kogan D, Holmes JA, Krasin M, Larkin C, Marcus KJ, Maxim PG, McClelland S 3rd, Murphy B, Palmer JD, Perkins SM, Shen CJ, Terezakis S, Bush K, Hiniker SM. Feasibility of the Audio-Visual Assisted Therapeutic Ambience in Radiotherapy (AVATAR) System for Anesthesia Avoidance in Pediatric Patients: A Multicenter Trial. Int J Radiat Oncol Biol Phys. 2023 Sep 1;117(1):96-104. doi: 10.1016/j.ijrobp.2023.03.063. Epub 2023 Mar 30.'}]}, 'descriptionModule': {'briefSummary': 'To determine the success rate of the AVATAR audio-visual system. All patients enrolled in the study will be counted, and each patient who is able to undergo at least one fraction without anesthesia will count as a success while each patient who does not have at least one fraction without anesthesia will count as a failure. The success rate will be the proportion of patients who are successes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The age range of patients is 3-10 years old, and there is no discrimination on ethnic background in recruitment for this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients ages 3-10 receiving radiotherapy qualify for enrollment.\n* The patient must speak English or Spanish.\n\nExclusion Criteria:\n\n* If parent/guardian is unable to take part in helping to complete questionnaires\n* Patients with malignancies of the eye for which radiation is planned\n* Patients that do not speak English or Spanish'}, 'identificationModule': {'nctId': 'NCT03991156', 'briefTitle': 'AVATAR Anesthesia Alternative in Pediatric Radiotherapy: A Multi-Center Study', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'AVATAR Anesthesia Alternative in Pediatric Radiotherapy: A Multi-Center Study', 'orgStudyIdInfo': {'id': 'IRB-47864'}, 'secondaryIdInfos': [{'id': 'PEDSVAR0050', 'type': 'OTHER', 'domain': 'OnCore'}, {'id': 'IRB-47864', 'type': 'OTHER', 'domain': 'Stanford IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Audio-Visual Assisted Therapeutic Ambience in Radiotherapy', 'interventionNames': ['Device: Audio-Visual Assisted Therapeutic Ambience in Radiotherapy', 'Other: Quality of Life Survey, PedsQL3.0', 'Other: Yale Preoperative Anxiety Scale Short Form (mYPAS-SF)']}], 'interventions': [{'name': 'Audio-Visual Assisted Therapeutic Ambience in Radiotherapy', 'type': 'DEVICE', 'otherNames': ['AVATAR'], 'description': 'Audio Visual System', 'armGroupLabels': ['Audio-Visual Assisted Therapeutic Ambience in Radiotherapy']}, {'name': 'Quality of Life Survey, PedsQL3.0', 'type': 'OTHER', 'description': 'Quality of life survey using the PedsQL 3.0 Cancer Module', 'armGroupLabels': ['Audio-Visual Assisted Therapeutic Ambience in Radiotherapy']}, {'name': 'Yale Preoperative Anxiety Scale Short Form (mYPAS-SF)', 'type': 'OTHER', 'description': 'Yale Preoperative Anxiety Scale Short Form (mYPAS-SF).\\[24\\] is a survey to measure anxiety', 'armGroupLabels': ['Audio-Visual Assisted Therapeutic Ambience in Radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '47405', 'city': 'Bloomington', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.16533, 'lon': -86.52639}}, {'zip': '21218', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute/Brigham & Women Children Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55455', 'city': 'Minneota', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.55885, 'lon': -95.98559}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "St. Louis Children's Hospital", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester School of Medicine', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's/UC Health Proton Therapy Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'St. Jude Children Hospital', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'Susan M Hiniker', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}