Dynamic Infrared Thermography as an Alternative to CT Angiography

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: DIRT

• Registration Number: NCT02806518
• Lead Sponsor: University Hospital of North Norway

Brief 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.

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2016-06
• Study First Submitted: 2016-06-15
• Study First Submitted QC: 2016-06-17
• Last Update Submitted: 2016-06-17
• Study First Posted: 2016-06-20
• Last Update Posted: 2016-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

• Patients scheduled for breast reconstruction with DIEP flap

Exclusion Criteria

• Prior breast reconstruction / abdominal flap surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women scheduled for DIEP	DIRT	Women scheduled for DIEP breast reconstruction after mastectomy due to breast cancer are examined with DIRT, hand-held Doppler and CTA

Primary Outcome Measures

Name	Time	Method
Comparison of DIRT with hand-held Doppler, CTA and intraoperative findings	Preoperative	Comparison of localization of hot spots on DIRT and arterial Doppler sound locations, perforators on CTA and useful perforators seen intraoperatively

Secondary Outcome Measures

Name	Time	Method
Surgical results	First postoperative month	Registration of flap failure (patients operated with DIEP based on perforator indicated with DIRT)

Trial Locations

Locations (1)

University Hospital of North Norway; 🇳🇴 Tromsø, Trom, Norway