Dynamic Infrared Thermography as an Alternative to CT Angiography

Breast Cancer Clinical Trial

— DIRT  

Official title:

Evaluation of Dynamic Infrared Thermography as an Alternative to CT Angiography for Perforator Mapping in Breast Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02806518
• Other study ID #: 2009/17(REK)
• Status: Completed
• Phase: N/A
• First received: June 15, 2016
• Last updated: June 17, 2016
• Start date: April 2009
• Est. completion date: April 2012

Study information

• Verified date: June 2016
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients scheduled for breast reconstruction with DIEP flap

Exclusion Criteria:

• Prior breast reconstruction / abdominal flap surgery

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• DIRT
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.

Locations

Country	Name	City	State
Norway	University Hospital of North Norway	Tromsø	Trom

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of North Norway	University of Tromso

Country where clinical trial is conducted

Norway, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of DIRT with hand-held Doppler, CTA and intraoperative findings	Comparison of localization of hot spots on DIRT and arterial Doppler sound locations, perforators on CTA and useful perforators seen intraoperatively	Preoperative	No
Secondary	Surgical results	Registration of flap failure (patients operated with DIEP based on perforator indicated with DIRT)	First postoperative month	No