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Completed

NCT Number: NCT02806518

Dynamic Infrared Thermography as an Alternative to CT Angiography

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.

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Key information

Age range

25 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital of North Norway

Tromsø, Trom, 9038, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled for breast reconstruction with DIEP flap

Exclusion criteria

  • Prior breast reconstruction / abdominal flap surgery

Treatment and study plan

DIRT

Procedure

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.

Primary outcomes

  1. Comparison of DIRT with hand-held Doppler, CTA and intraoperative findings

    Time frame: Preoperative

    Comparison of localization of hot spots on DIRT and arterial Doppler sound locations, perforators on CTA and useful perforators seen intraoperatively

Secondary outcomes

  1. Surgical results

    Time frame: First postoperative month

    Registration of flap failure (patients operated with DIEP based on perforator indicated with DIRT)

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Collaborators

  • University of Tromso

Registry information

Official study title

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

Acronym: DIRT

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 20, 2016
Registry last updated
Jun 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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