Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2026-03-04 @ 1:22 PM
Study NCT ID:
NCT02806518
Status:
COMPLETED
Last Update Posted:
2016-06-20
First Post:
2016-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dynamic Infrared Thermography as an Alternative to CT Angiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-17', 'studyFirstSubmitDate': '2016-06-15', 'studyFirstSubmitQcDate': '2016-06-17', 'lastUpdatePostDateStruct': {'date': '2016-06-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of DIRT with hand-held Doppler, CTA and intraoperative findings', 'timeFrame': 'Preoperative', 'description': 'Comparison of localization of hot spots on DIRT and arterial Doppler sound locations, perforators on CTA and useful perforators seen intraoperatively'}], 'secondaryOutcomes': [{'measure': 'Surgical results', 'timeFrame': 'First postoperative month', 'description': 'Registration of flap failure (patients operated with DIEP based on perforator indicated with DIRT)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['DIEP', 'Computed Tomography', 'Doppler', 'Thermography'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '20392982', 'type': 'BACKGROUND', 'citation': 'Cina A, Salgarello M, Barone-Adesi L, Rinaldi P, Bonomo L. Planning breast reconstruction with deep inferior epigastric artery perforating vessels: multidetector CT angiography versus color Doppler US. Radiology. 2010 Jun;255(3):979-87. doi: 10.1148/radiol.10091166. Epub 2010 Apr 14.'}, {'pmid': '20024888', 'type': 'BACKGROUND', 'citation': 'Mathes DW, Neligan PC. Current techniques in preoperative imaging for abdomen-based perforator flap microsurgical breast reconstruction. J Reconstr Microsurg. 2010 Jan;26(1):3-10. doi: 10.1055/s-0029-1244806. Epub 2009 Dec 18.'}, {'pmid': '9664879', 'type': 'BACKGROUND', 'citation': 'Blondeel PN, Beyens G, Verhaeghe R, Van Landuyt K, Tonnard P, Monstrey SJ, Matton G. Doppler flowmetry in the planning of perforator flaps. Br J Plast Surg. 1998 Apr;51(3):202-9. doi: 10.1016/s0007-1226(98)80010-6.'}, {'pmid': '21620152', 'type': 'BACKGROUND', 'citation': 'de Weerd L, Mercer JB, Weum S. Dynamic infrared thermography. Clin Plast Surg. 2011 Apr;38(2):277-92. doi: 10.1016/j.cps.2011.03.013.'}, {'pmid': '19700958', 'type': 'BACKGROUND', 'citation': 'de Weerd L, Weum S, Mercer JB. The value of dynamic infrared thermography (DIRT) in perforatorselection and planning of free DIEP flaps. Ann Plast Surg. 2009 Sep;63(3):274-9. doi: 10.1097/SAP.0b013e3181b597d8.'}, {'pmid': '27421763', 'type': 'DERIVED', 'citation': 'Weum S, Mercer JB, de Weerd L. Evaluation of dynamic infrared thermography as an alternative to CT angiography for perforator mapping in breast reconstruction: a clinical study. BMC Med Imaging. 2016 Jul 15;16(1):43. doi: 10.1186/s12880-016-0144-x.'}]}, 'descriptionModule': {'briefSummary': 'Dynamic infrared thermography (DIRT) is an imaging method that does not require ionizing radiation or contrast injection. The study evaluates if DIRT can be an alternative to computed tomographic angiography (CTA) in perforator mapping. DIRT findings are compared with hand-held Doppler, CTA and intraoperative findings.', 'detailedDescription': 'In deep inferior epigastric perforator flap (DIEP) breast reconstruction the blood supply to the DIEP flap is reestablished by anastomosing the perforator to the internal mammary vessels. The selected perforator is crucial for flap survival as it is the only source of blood supply to the flap. CTA allows for precise anatomical description of the origin of perforators, their intramuscular course and point of fascia penetration but expose the patient to ionizing radiation and an intravenous contrast medium.\n\nDIRT is an imaging method that does not require ionizing radiation or contrast injection. The study evaluates if DIRT can be an alternative to CTA in perforator mapping. The study is performed in a hospital where DIRT and CTA have been established preoperative imaging methods that have been used for several years as routine examinations for all DIEP breast reconstruction patients.\n\n25 patients scheduled for secondary breast reconstruction with a DIEP flap are included. Preoperatively, the lower abdomen is examined with hand-held Doppler, DIRT and CTA. Arterial Doppler sound locations are marked on the skin.\n\nDIRT examination involves rewarming of the abdominal skin after a mild cold challenge. The locations of hot spots on DIRT are compared with the arterial Doppler sound locations. The rate and pattern of rewarming of the hot spots are analyzed. Multiplanar CT reconstructions are used to see if hot spots are related to perforators on CTA and intraoperative findings.\n\nWhen intraoperative findings confirm that a useful perforator is located at the same localization as indicated with DIRT, this perforator is used for DIEP breast reconstruction. Postoperatively the surgical outcome and possible complications related to the selected perforator are evaluated.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women scheduled for DIEP breast reconstruction after mastectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for breast reconstruction with DIEP flap\n\nExclusion Criteria:\n\n* Prior breast reconstruction / abdominal flap surgery'}, 'identificationModule': {'nctId': 'NCT02806518', 'acronym': 'DIRT', 'briefTitle': 'Dynamic Infrared Thermography as an Alternative to CT Angiography', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of North Norway'}, 'officialTitle': 'Evaluation of Dynamic Infrared Thermography as an Alternative to CT Angiography for Perforator Mapping in Breast Reconstruction', 'orgStudyIdInfo': {'id': '2009/17(REK)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women scheduled for DIEP', 'description': 'Women scheduled for DIEP breast reconstruction after mastectomy due to breast cancer are examined with DIRT, hand-held Doppler and CTA', 'interventionNames': ['Procedure: DIRT']}], 'interventions': [{'name': 'DIRT', 'type': 'PROCEDURE', 'description': 'An infrared camera is used to capture video sequences of thermal images before, during and after exposure of the lower abdomen to a cold challenge.', 'armGroupLabels': ['Women scheduled for DIEP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9038', 'city': 'Tromsø', 'state': 'Trom', 'country': 'Norway', 'facility': 'University Hospital of North Norway', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}], 'overallOfficials': [{'name': 'Sven Weum, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of North Norway', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Tromso', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}