AzTrials
AzTrials

Fat NecrosisPhase 3FAFINCT05507710

Indocyanine Green for Perfusion Assessment of DIEP Flaps

A Phase 3 study testing Near-infrared fluorescence imaging of perfusion in people with Fat Necrosis, run by Leiden University Medical Center at 2 sites in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Currently during DIEP flap reconstruction, the perfusion of the flap is assessed by the clinical view of the surgeon. Identification of demarcated ischemic zones of the DIEP flap could be optimized by using fluorescence imaging with indocyanine green (ICG) in order to lower the rate of fat necrosis. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Fat Necrosis
What is being tested?
Near-infrared fluorescence imaging of perfusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
2 sitesNetherlands
Study dates
1 May 2019to 1 Oct 2025
Phase
Phase 3
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients 18 years of age and older
  • Who underwent a mastectomy for breast cancer or prophylactic due to genetic predisposition
  • Patients scheduled for elective surgery for autologous breast reconstruction, uni- or bilateral, using DIEP or msTRAM flaps. In case of bilateral breast reconstruction the flaps should be bilateral anastomosed.
  • Written informed consent

Who cannot join

  • Allergy to ICG, iodine or shellfish
  • Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the patient
  • Impaired renal function defined as eGFR< 50 mL/min/1.73m2 (this can be seen in the standard preoperative lab results)

Trial locations and contacts

2 sites in 1 country.

Alexander L. Vahrmeijer, MD, PhD contact

+31 71 526 2309

a.l.vahrmeijer@lumc.nl

Pieter S. Verduijn, MD contact

0715296212

P.S.Verduijn@lumc.nl

Netherlands2 sites, 2 recruiting

  • Leiden University Medical Center

    Leiden, 2333ZA

    Alexander L. Vahrmeijer, MD, PhD, +31 71 526 2309, a.l.vahrmeijer@lumc.nl

    Pieter S. Verduijn, MD, +31715296212, p.s.verduijn@lumc.nl

    Recruiting

  • Erasmus Medical Center

    Rotterdam, 3015GD

    Marc A.M. Mureau, MD, PhD, +31 614390753, m.mureau@erasmusmc.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: Indocyanine Green for Perfusion Assessment of DIEP Flaps: A Dutch Multicenter Randomized Controlled Trial

Currently during DIEP flap reconstruction, the perfusion of the flap is assessed by the clinical view of the surgeon. Identification of demarcated ischemic zones of the DIEP flap could be optimized by using fluorescence imaging with indocyanine green (ICG) in order to lower the rate of fat necrosis. This study evaluates whether intraoperative perfusion assessment with ICG fluorescence imaging causes a lower rate of fat necrosis compared to conventional intraoperative clinical evaluation of DIEP flaps.

Read the detailed description

Rationale: Autologous breast reconstruction after mastectomy due to cancer or prophylactically due to genetically increased risk is frequently performed. A complication that may occur after a deep inferior epigastric artery (DIEP) reconstruction is the occurrence of fat necrosis in the transplanted flap due to ischemia (reperfusion injury). Identification of deep inferior epigastric artery perforators and identification of demarcated ischemic zones of the DIEP flap can be optimized by using fluorescence imaging with indocyanine green (ICG), as has been demonstrated in previous studies. This could result in less fat necrosis, less partial flap loss, and other complications. A randomized controlled trial would be the best study design to assess the value of ICG in determining the perfusion of DIEP flaps, thereby reducing the occurrence of fat necrosis and other complications.

Objective: To determine whether fluorescence imaging using ICG for the assessment of DIEP flap perfusion during surgery decreases the occurrence of fat necrosis compared to standard intraoperative clinical assessment of DIEP flap perfusion.

Study design: This is a two-armed randomized controlled trial:

  • interventional arm: evaluation of flap perfusion based on 1) clinical parameters, and 2) fluorescence imaging using ICG
  • conventional arm: evaluation of flap perfusion based on clinical parameters only

Study population: Patients scheduled for elective surgery for autologous breast reconstruction, uni- or bilateral, using DIEP or muscle sparing transverse rectus abdominis muscle (msTRAM) flaps. Female patients 18 years of age and older.

Intervention (if applicable): evaluation of flap perfusion based on 1) clinical parameters, and 2) fluorescence imaging using ICG

Main study parameters/endpoints: Difference in percentage of fat necrosis after autologous breast reconstruction using DIEP flaps between patients in whom fluorescence imaging was used and patients in whom flaps were clinically assessed.

Conditions
Fat Necrosis
Being tested
Near-infrared fluorescence imaging of perfusion
Keywords
Fat necrosis, Near-infrared fluorescence imaging, Indocyanine green, Free flap surgery, Breast reconstruction, Perfusion
Medical subject headings
Fat Necrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Near-infrared fluorescence imaging of perfusionDiagnostic test

    Imaging with ICG near-infrared fluorescence is performed besides clinical judgement of the DIEP flap for perfusion evaluation. Based on fluorescence imaging, additional malperfused area(s) are resected.

Study groups in NCT05507710
Study groupRoleWhat they receive
Interventional study armActive comparatorSurgery will be performed according to local protocol. Flap viability during adequate hemodynamic conditions is evaluated a standard of care. Then after anastomosis of the flap but before the inset, the second intervention is performed. Intervention: evaluation of the perfusion of the skin and fat with fluorescence imaging using ICG. The flap is marked according to the fluorescence imaging evaluation, and parts without perfusion are resected. The remaining flap is inset to the remaining breast skin.
Receives: Diagnostic Test: Near-infrared fluorescence imaging of perfusion
Control armNo interventionSurgery will be performed according to local protocol.Flap viability during adequate hemodynamic conditions is evaluated as standard of care. Then after anastomosis of the flap but before the inset, the surgeon will leave the room, the researcher will make a recording of the flap and this will have no consequences for the procedure.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical relevant fat necrosis

    Clinically relevant fat necrosis is defined as a palpable mass, either painful or not, and with or without aesthetic complaints, and developed within three months after surgery. The following grading system according to Lie et al. is used. Only grade III till IV is classified as clinical relevant fat necrosis.

    III: Major compromised reconstructive outcome, flap involvement:15-50%, clinical findings: Major contour defects (multiple), surgical management: Debridement/secondary procedure IV: Subtotal poor reconstructive outcome, flap involvement: >50%, clinical findings: Skin defects, inadequate volume, volume loss, surgical management: Second local flap/ re-intervention initial flap

    Measured: 3 months

Secondary outcomes (7)

  1. Quantify perfusion of flaps

    Based on NIRF recordings and correlate these to the development of fat necrosis.

    Measured: 3 months

  2. Registration of re-interventions

    necessary to treat fat necrosis, in numbers and percentages

    Measured: 3 months

  3. Registration of postoperative complications

    in numbers and percentages

    Measured: 3 months

  4. Duration of surgery in minutes

    Of all surgical procedures included

    Measured: 1 day

  5. Percentage extra resected tissue

    of initial flap in grams based on perfusion assessment

    Measured: 1 day

  6. Personal experience/opinion of surgeon performing surgery with fluorescent imaging using ICG.

    After every surgery the NASA TASK Load Index is taken by the surgeon.

    Measured: 1 day

  7. Patient satisfaction

    using BREAST-Q questionnaire, this is an validated questionnaire that is used in multiple research for measuring patient satisfaction

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2022
  2. Study start1 May 2019
  3. Primary completion1 Sep 2025 (estimated)
  4. Study completion1 Oct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a two-armed randomized controlled trial: * interventional arm: evaluation of flap perfusion based on 1) clinical parameters, and 2) fluorescence imaging using ICG * conventional arm: evaluation of flap perfusion based on clinical parameters only
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05507710
Sponsor's protocol ID
NL 68623.058.18
Acronym
FAFI
Status last verified
Aug 2022
First submitted
17 Aug 2022
Last updated
19 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tange FP, Verduijn PS, Sibinga Mulder BG, van Capelle L, Koning S, Driessen C, Mureau MAM, Vahrmeijer AL, van der Vorst JR. Near-infrared fluorescence angiography with indocyanine green for perfusion assessment of DIEP and msTRAM flaps: A Dutch multicenter randomized controlled trial. Contemp Clin Trials Commun. 2023 Apr 2;33:101128. doi: 10.1016/j.conctc.2023.101128. eCollection 2023 Jun.

    PubMed 37091505

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Near-infrared fluorescence imaging of perfusion in people with Fat Necrosis, run by Leiden University Medical Center at 2 sites in Netherlands.

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 4 inclusion and 3 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 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Alexander L. Vahrmeijer, MD, PhD (+31 71 526 2309, a.l.vahrmeijer@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical relevant fat necrosis (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05507710, which also lists 1 linked publication.

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 19 Aug 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in