Reconstructive Surgical ProceduresNCT04115995
DIEP Flap Perfusion Evaluated by DIRT and ICG-FA.
An observational study of Reconstructive Surgical Procedures, run by University Hospital of North Norway at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Reconstructive Surgical Procedures
- What is being tested?
- Dynamic infrared thermography (DIRT) and indocyanine green fluorescence angiography (ICG-FA)
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- 16 Jan 2019to 31 Dec 2019
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female patients selected for autologous breast reconstruction with a DIEP flap.
Who may be able to join
- 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.
Who cannot join
- 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.
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- Significant medical comorbidities that make the patient a poor surgical candidate.
- Sigarette smoking or snuff.
- Obesity / BMI > 30.
- Previous abdominal suction-assisted lipectomy.
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Univesity Hospital of North Norway
Tromsø, 9038
Louis de Weerd, MD, PhD, 0047 77669793, louis.De.Weerd@unn.no
About this study
Official title: Perforator Mapping and Anastomosis Patency Evaluated by Dynamic Fluorescence Video Angiography of Indocyanine Green and Infrared Thermography.
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.
Read the 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.
.
- Conditions
- Reconstructive Surgical Procedures
- Being tested
- Dynamic infrared thermography (DIRT) and indocyanine green fluorescence angiography (ICG-FA)
- Keywords
- Breast reconstruction, Perforator flaps, Computer Tomography, Indocyanine green, Fluorescence angiography, Infrared thermography, Dynamic infrared thermography, Doppler ultrasound, Angiosome, Perforasome, Flap perfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic infrared thermography (DIRT) and indocyanine green fluorescence angiography (ICG-FA)Diagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 2 year
Quality of microvascular anastomosis by measuring perfusion through the anastomosis using dynamic infrared thermography and laser fluorescence angiography of indocyanine green.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start16 Jan 2019
- Primary completion24 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reconstructive Surgical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- UiT The Arctic University of Norway
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04115995
- Sponsor's protocol ID
- 22017/1641
- Status last verified
- Dec 2018
- First submitted
- 16 Apr 2019
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perforator Mapping and Anastomosis Patency Evaluated by Dynamic Fluorescence Video Angiography of Indocyanine Green and Infrared Thermography.
- ClinicalTrials.gov ID
- NCT04115995
- Acronym / sponsor ID
- 22017/1641
- Conditions
- Reconstructive Surgical Procedures
- Keywords
- Breast reconstruction, Perforator flaps, Computer Tomography, Indocyanine green, Fluorescence angiography, Infrared thermography, Dynamic infrared thermography, Doppler ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- UiT The Arctic University of Norway
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 24 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 4 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 25 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients selected for autologous breast reconstruction with a DIEP flap.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | – |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reconstructive Surgical Procedures, run by University Hospital of North Norway at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Louis de Weerd, MD, PhD, (004777669793, louis.de.weerd@unn.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019.