Clinical Trials Directory

Trials / Completed

CompletedNCT02806518

Dynamic Infrared Thermography as an Alternative to CT Angiography

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

Status
Completed
Phase
Study type
Observational
Enrollment
25 (actual)
Sponsor
University Hospital of North Norway · Academic / Other
Sex
Female
Age
25 Years – 75 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
PROCEDUREDIRTAn infrared camera is used to capture video sequences of thermal images before, during and after exposure of the lower abdomen to a cold challenge.

Timeline

Start date
2009-04-01
Primary completion
2012-04-01
Completion
2012-04-01
First posted
2016-06-20
Last updated
2016-06-20

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT02806518. Inclusion in this directory is not an endorsement.