Ignite Creation Date:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2026-01-04 @ 8:51 AM
Study NCT ID:
NCT02776995
Status:
UNKNOWN
Last Update Posted:
2019-04-09
First Post:
2016-05-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tumor Monitoring Using Thermography During Radiation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013817', 'term': 'Thermography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D062125', 'term': 'Thermometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-07', 'studyFirstSubmitDate': '2016-05-10', 'studyFirstSubmitQcDate': '2016-05-16', 'lastUpdatePostDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of IR : Infra-Red radiation emitted at wavelengths 0.8-1nm', 'timeFrame': 'Before the first fraction of radiation and every 5 fraction until the end of radiation therapy, approximately 4-5 weeks.', 'description': 'Mathematical analysis of the thermic image'}], 'secondaryOutcomes': [{'measure': 'Dermal side effects during radiation therapy using CTCAE v4.0', 'timeFrame': 'Before the first fraction of radiation and every 5 fraction until the end of radiation therapy, approximately 4-5 weeks.', 'description': 'Clinical assesment of the side effects by physician.'}, {'measure': 'US/CT scans', 'timeFrame': 'The tumor size in cubic cm will be mesured prior to first fraction of radiation, and 2 weeks following the end of radiation session. Time for final evaluation: approximately 6-7 weeks.', 'description': 'The tumor size will be measures to evaluate the efficacy of the radiation treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Malignancy']}, 'descriptionModule': {'briefSummary': 'This research aims to investigate the correlation between tumor temperature difference and biological factors, such as size, metabolism, treatment response, and tumor aggressiveness.\n\nIn addition, normal tissue response to adjuvant radiation therapy in treated organs following surgery, will be evaluated.', 'detailedDescription': 'During radiation session, the investigators would evaluate the changes that will be detected by thermal imaging and correlate them with visible side effects as well as with known tumor biology factors and skin-tumor distance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* signed informed consent\n* will undergo radiation therapy for palliation or curative intent due to cancer, biopsy proven\n\nExclusion Criteria:\n\n* not eligible to sign informed consent'}, 'identificationModule': {'nctId': 'NCT02776995', 'briefTitle': 'Tumor Monitoring Using Thermography During Radiation Therapy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Tumor Monitoring Using Thermography During Radiation Therapy', 'orgStudyIdInfo': {'id': '1216-14-SMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients undergoing radiation', 'description': 'In this study, patients undergoing radiation treatment will undergo thermography imaging during radiation treatment course. Patients will be evaluated with thermography imaging every 5 fraction of radiation, starting prior to the first radiation treatment, periodically, until the end of radiation therapy (a period of several weeks).', 'interventionNames': ['Other: Thermography imaging']}], 'interventions': [{'name': 'Thermography imaging', 'type': 'OTHER', 'description': 'Thermography imaging of the treated - irradiated body area.', 'armGroupLabels': ['Patients undergoing radiation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ramat Gan', 'status': 'RECRUITING', 'country': 'Israel', 'facility': 'Merav Ben David', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'centralContacts': [{'name': 'Merav Ben-David, MD', 'role': 'CONTACT', 'email': 'merav.ben-david@sheba.health.gov.il', 'phone': '972-3-5305086'}, {'name': 'Zvi Symon, MD', 'role': 'CONTACT', 'email': 'zvi.symon@sheba.health.gov.il', 'phone': '972-3-5305080'}], 'overallOfficials': [{'name': 'Merav Ben-David, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Tel Aviv University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical and Radiation Oncologist, Head of Breast Radioation Unit', 'investigatorFullName': 'Dr. Merav Ben-David', 'investigatorAffiliation': 'Sheba Medical Center'}}}}