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DIEP Flap Perfusion Evaluated by DIRT and ICG-FA.

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ClinicalTrials.gov Identifier: NCT04115995
Recruitment Status : Recruiting
First Posted : October 4, 2019
Last Update Posted : October 4, 2019
Sponsor:
Collaborator:
UiT The Arctic University of Norway
Information provided by (Responsible Party):
University Hospital of North Norway

Brief Summary:
Patients selected for DIEP breast reconstruction were examined with preoperative CTA, Doppler Ultrasound, dynamic infrared thermography (DIRT) and Indocyanin green fluorescent angiography (ICG-FA) for perforator mapping. DIRT and ICG-FA were used to evaluate perfusion of selected perforators. Following anastomoses for the DIEP flap to internal mammary vessels , patency of the anastomosis was evaluated with DIRT and ICG-FA. Recorded images from all the modules were compared.

Condition or disease Intervention/treatment
Reconstructive Surgical Procedures Diagnostic Test: Dynamic infrared thermography (DIRT) and indocyanine green fluorescence angiography (ICG-FA)

Detailed Description:

Introduction:

'The primary aim of our study is to compare invasive and non-invasive techniques to select a dominant perforator when harvesting a DIEP-flap for autologous breast reconstruction.

The secondary aim is to compare Dynamic Infrared Thermography (DIRT) and Laser Fluorescence Angiography (LFA) of Indocyanine green (ICG) in order to see whether they could be useful in the early detection of insufficient perfusion following the microvascular anastomotic procedure in DIEP flaps.

Material and Method:

Patients selected for breast reconstruction with autologous tissue were examined with preoperative CTA and a handheld Doppler Ultrasound for perforator mapping. Thereafter visual images from same area was obtained with dynamic infraredeed thermography (DIRT) and Indocyanin green fluorescent angiography (ICG-FA) before and after dissection of the skin flap with preserved medial and lateral DIEP perforators. Reconstructed breasts with hemi-DIEP-flaps were intraoperatively evaluated with DIRT and LFA immediately after the completion and opening of the microvascular anastomosis.The recorded images from the different techniques were assesses in relation to clinical outcome.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Perforator Mapping and Anastomosis Patency Evaluated by Dynamic Fluorescence Video Angiography of Indocyanine Green and Infrared Thermography.
Actual Study Start Date : January 16, 2019
Estimated Primary Completion Date : December 24, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Dynamic infrared thermography (DIRT) and indocyanine green fluorescence angiography (ICG-FA)
    DIRT and ICG FA are used intraoperatively to evaluate perfusion of the perforators and the anastomosis. Both technique are compared in their ability to visualize perfusion.


Primary Outcome Measures :
  1. Assessment of quality and location of perforating blood vessels with dynamic infrared thermography and indocyanine green angiography in autologous breast reconstruction: A comparative imaging study. [ Time Frame: 2 year ]
    Pre-and intraoperative use of two different imaging technologies to assess quality and location of perforating blood vessels in autologous breast reconstruction. In this study we will compare images obtained using a non-invasive imaging technique, dynamic infrared thermography and an invasive imaging technique, laser fluorescence angiography of indocyanine green.

  2. Quality of microvascular anastomosis by measuring perfusion through the anastomosis using dynamic infrared thermography and laser fluorescence angiography of indocyanine green. [ Time Frame: 2 years ]
    The microvascular anastomosis provides blood supply to tissue used in breast reconstruction. The blood flow through the microvascular anastomosis can be monitored by use of different imaging techniques. In this study, perfusion images obtained by non-invasive dynamic infrared thermography and invasive fluorescence angiography of indocyanine green will be compared.



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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only female patients are included for breast reconstruction after treatment for breast cancer.
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Female patients selected for autologous breast reconstruction with a DIEP flap.
Criteria

Inclusion Criteria:

  • Post mastectomy.
  • Previously breast cancer patent treated with radiation therapy.
  • Breast implant reconstruction is not possible or undesired.
  • Healthy patient with moderate amounts of abdominal skin laxity.
  • Patient who requires a minimal to moderate volume breast reconstruction.
  • The patient willing to undergo the long, complex procedure and prolonged postoperative recovery.
  • The patient willing to accept an abdominal scar and a potential for donor site morbidities.
  • Patients operated with prophylactic salpingo-oophorectomy due to BRCA gene mutation.

Exclusion Criteria:

  • Pregnancy and lactation.
  • Patents below the age of 18 year.
  • Renal failure or hepatic failure.
  • Previous allergic reactions to ICG and iodide.
  • Abdominal donor site that cannot be closed primarily.
  • Previous TRAM flap or abdominoplasty.
  • Significant medical comorbidities that make the patient a poor surgical candidate.
  • Sigarette smoking or snuff.
  • Obesity / BMI > 30.
  • Previous abdominal suction-assisted lipectomy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04115995


Contacts
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Contact: Louis de Weerd, MD, PhD, 004777669793 louis.de.weerd@unn.no

Locations
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Norway
Univesity Hospital of North Norway Recruiting
Tromsø, Norway, 9038
Contact: Louis de Weerd, MD, PhD    0047 77669793    louis.De.Weerd@unn.no   
Sponsors and Collaborators
University Hospital of North Norway
UiT The Arctic University of Norway

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Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT04115995     History of Changes
Other Study ID Numbers: 22017/1641
First Posted: October 4, 2019    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital of North Norway:
Breast reconstruction
Perforator flaps
Computer Tomography
Indocyanine green
Fluorescence angiography
Infrared thermography
Dynamic infrared thermography
Doppler ultrasound
Angiosome
Perforasome
Flap perfusion