- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02806518
Dynamic Infrared Thermography as an Alternative to CT Angiography (DIRT)
Evaluation of Dynamic Infrared Thermography as an Alternative to CT Angiography for Perforator Mapping in Breast Reconstruction
Studienübersicht
Detaillierte Beschreibung
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.
DIRT 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.
25 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.
DIRT 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.
When 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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Trom
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Tromsø, Trom, Norwegen, 9038
- University Hospital of North Norway
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Patients scheduled for breast reconstruction with DIEP flap
Exclusion Criteria:
- Prior breast reconstruction / abdominal flap surgery
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
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Women scheduled for DIEP
Women scheduled for DIEP breast reconstruction after mastectomy due to breast cancer are examined with DIRT, hand-held Doppler and CTA
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Comparison of DIRT with hand-held Doppler, CTA and intraoperative findings
Zeitfenster: Preoperative
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Comparison of localization of hot spots on DIRT and arterial Doppler sound locations, perforators on CTA and useful perforators seen intraoperatively
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Preoperative
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Surgical results
Zeitfenster: First postoperative month
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Registration of flap failure (patients operated with DIEP based on perforator indicated with DIRT)
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First postoperative month
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Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Sven Weum, MD PhD, Associate professor
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 2009/17(REK)
Plan für individuelle Teilnehmerdaten (IPD)
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