Reconstructive SurgeryAFLUNCT01681797
Fluorescence Angiography: Planning and Monitoring of Perforator Flaps
A study testing Fluorescence angiography (Fluobeam™ imaging system developed by Fluoptics company) in people with Reconstructive Surgery, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The purpose of this study is to determine whether fluorescence angiography is an effectiveness technique for the localization of vascular perforators and their area of perfusion and for the postoperative monitoring of flap perfusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reconstructive Surgery
- What is being tested?
- Fluorescence angiography (Fluobeam™ imaging system developed by Fluoptics company)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2012to 10 Oct 2015
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- perforator flap reconstruction whatever the indication (cancer, trauma, malformations). The main targets are the fibula flaps, anterolateral thigh flaps and inferior epigastric flaps
- consenting patient
Who cannot join
- known indocyanine green allergy
- pregnant woman, parturient woman or nursing woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fluorescence Angiography With Fluobeam™ Camera (Fluoptics Company): Planning and Monitoring of Perforator Flaps
The purpose of this study is to determine whether fluorescence angiography is an effectiveness technique for the localization of vascular perforators and their area of perfusion and for the postoperative monitoring of flap perfusion.
Read the detailed description
Reconstructive surgery is intended to replace amputated anatomical regions by autologous tissue taken from distant locations: flaps. The goal is to restitute ad integrum with minimal sequelae. Among the flaps available, perforator flaps have the advantage of being highly plastic, large and can be taken from accessory vessels the loss of wich does not compromise the vitality of the sampling site. However their more variable anatomy requires irradiating preoperative morphological assessment (CT angiography) or a doppler ultrasonography that is not always performed by the surgeon himself and does not distinguish between muscle perforator and skin perforator.
Fluorescence angiography is a superficial exploration technique of vascularization. After intravenous injection of a tracer (indocyanine green ICG), fluorescence angiography provides useful surface angiographic imaging in real-time. It can also help in monitoring intraoperative and postoperative quality of vascular anastomoses. Although fluorescence angiography has numerous applications (ophthalmology, neurosurgery, liver transplantation...), its usefulness in surgical flaps is only supported by a few publications. None really validate its clinical value by comparing it to reference investigations (CT angiography or doppler ultrasonography).
40 candidate for reconstructive surgery will be included in this study. The day before surgery, in addition to the usual technique used to locate perforator flaps, the patient will receive an injection of 0.025 mg / kg Infracyanine® (indocyanine green) and the area of interest of the flap will be explored with the Fluobeam™ camera.
Two hours after the surgery, during the usual clinical monitoring of the vitality of the flap, a new injection of Infracyanine® will test perfusion of the flap by measuring fluorescence intensity of the target area. These measurement will then be repeated every 6 hours for 4 days.
- Conditions
- Reconstructive Surgery
- Being tested
- Fluorescence angiography (Fluobeam™ imaging system developed by Fluoptics company)
- Keywords
- fluorescent angiography, reconstructive surgery, perforator flap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescence angiography (Fluobeam™ imaging system developed by Fluoptics company)Device
Also called The device used in this study is the Fluobeam™ imaging system developed by the company Fluoptics., the technique requires the injection of a tracer Infracyanine® (SERB pharmaceutical company)
Fluorescence angiography after intravenous injection of Infracyanine® (indocyanine green)
| Study group | Role | What they receive |
|---|---|---|
| add-on fluorescence angiography | Experimental | The surgeon will prescribe the usual morphological assessment of the proposed flap:
* CT angiography for an anterolateral thigh flap or an epigastric inferior flap
* A Doppler ultrasonography for a fibula flap.
In addition to the usual radiological technique used to locate the perforating arteries, the patient will have a fluorescence angiography prior to surgery, another just after the end of surgery and then one every six hours during the next 4 days. Receives: Device: Fluorescence angiography (Fluobeam™ imaging system developed by Fluoptics company) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between the position of perforator flap determined by fluorescence angiography and the real anatomic position of the flap determined after dissection
For each flap, the position of the flap determined by fluorescent angiography will be compared with the anatomic position (actual) determined on the relevant flap after dissection (gold standard).
Measured: During the first fluorescent angiography
Secondary outcomes (3)
Comparison between the position of the perforator flap determined by fluorescence angiography and the position of the flap determined by reference imaging techniques relevant to the flap (CT angiography or doppler ultrasonography)
For each flap, the position of the flap determined by fluorescent angiography will be compared with the position determined by reference imaging techniques relevant to the flap (CT angiography or doppler ultrasonography)
Measured: During the first fluorescent angiography
Intraoperative monitoring of the quality of micro-vascular anastomoses using fluorescent angiography
Intraoperative monitoring of vascular flow through the micro-anastomoses will be determined by:
- measuring the arterial and venous trans-anastomotic flow (ml / mm)
- flow measurement (ml / mm) of an equivalent diameter vessel located in the operative field and not affected by the anastomosis
- intrinsic transit time (in seconds) which is the time required for the fluorescence between the arterial anastomosis and the venous anastomosis
- the number of leaks around the anastomosis.
Measured: Just after micro-vascular anastomoses
Postoperative monitoring of flap perfusion using fluorescence angiography
This is to test the hypothesis that the dynamics of the fluorescence intensity in the area of interest is a prognostic factor for postoperative complications.
Measured: Every six hours for four days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2012 (estimated)
- Study startAug 2012
- Primary completion10 Oct 2015
- Study completion10 Oct 2015
Why it stopped: The study was stopped due to lack of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Reconstructive SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Georges BETTEGA, MD, PHD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01681797
- Sponsor's protocol ID
- DCIC/11/13
- Acronym
- AFLU
- Status last verified
- Apr 2019
- First submitted
- 31 Aug 2012
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Koenig A, Herve L, Gonon G, Josserand V, Berger M, Dinten JM, Boutet J, Peltie P, Coll JL, Rizo P. Fluorescence diffuse optical tomography for free-space and multifluorophore studies. J Biomed Opt. 2010 Jan-Feb;15(1):016016. doi: 10.1117/1.3309738.
PubMed 20210462
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorescence Angiography With Fluobeam™ Camera (Fluoptics Company): Planning and Monitoring of Perforator Flaps
- ClinicalTrials.gov ID
- NCT01681797
- Acronym / sponsor ID
- AFLU / DCIC/11/13
- Conditions
- Reconstructive Surgery
- Keywords
- fluorescent angiography, reconstructive surgery, perforator flap
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped due to lack of inclusion
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- 10 Oct 2015 (actual)
- Study completion
- 10 Oct 2015 (actual)
- First posted
- 10 Sep 2012 (estimated)
- 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.
The purpose of this study is to determine whether fluorescence angiography is an effectiveness technique for the localization of vascular perforators and their area of perfusion and for the postoperative monitoring of flap perfusion.
Detailed description
Reconstructive surgery is intended to replace amputated anatomical regions by autologous tissue taken from distant locations: flaps. The goal is to restitute ad integrum with minimal sequelae. Among the flaps available, perforator flaps have the advantage of being highly plastic, large and can be taken from accessory vessels the loss of wich does not compromise the vitality of the sampling site. However their more variable anatomy requires irradiating preoperative morphological assessment (CT angiography) or a doppler ultrasonography that is not always performed by the surgeon himself and does not distinguish between muscle perforator and skin perforator.
Fluorescence angiography is a superficial exploration technique of vascularization. After intravenous injection of a tracer (indocyanine green ICG), fluorescence angiography provides useful surface angiographic imaging in real-time. It can also help in monitoring intraoperative and postoperative quality of vascular anastomoses. Although fluorescence angiography has numerous applications (ophthalmology, neurosurgery, liver transplantation...), its usefulness in surgical flaps is only supported by a few publications. None really validate its clinical value by comparing it to reference investigations (CT angiography or doppler ultrasonography).
40 candidate for reconstructive surgery will be included in this study. The day before surgery, in addition to the usual technique used to locate perforator flaps, the patient will receive an injection of 0.025 mg / kg Infracyanine® (indocyanine green) and the area of interest of the flap will be explored with the Fluobeam™ camera.
Two hours after the surgery, during the usual clinical monitoring of the vitality of the flap, a new injection of Infracyanine® will test perfusion of the flap by measuring fluorescence intensity of the target area. These measurement will then be repeated every 6 hours for 4 days.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| add-on fluorescence angiography | Experimental | Device: Fluorescence angiography (Fluobeam™ imaging system developed by Fluoptics company)The surgeon will prescribe the usual morphological assessment of the proposed flap: * CT angiography for an anterolateral thigh flap or an epigastric inferior flap * A Doppler ultrasonography for a fibula flap. In addition to the usual radiological technique used to locate the perforating arteries, the patient will have a fluorescence angiography prior to surgery, another just after the end of surgery and then one every six hours during the next 4 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- perforator flap reconstruction whatever the indication (cancer, trauma, malformations). The main targets are the fibula flaps, anterolateral thigh flaps and inferior epigastric flaps
- consenting patient
Key exclusion criteria (2 listed)
- known indocyanine green allergy
- pregnant woman, parturient woman or nursing woman
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 |
|---|---|---|
| Fluorescence angiography (Fluobeam™ imaging system developed by Fluoptics company)Also: The device used in this study is the Fluobeam™ imaging system developed by the company Fluoptics., the technique requires the injection of a tracer Infracyanine® (SERB pharmaceutical company)Fluorescence angiography after intravenous injection of Infracyanine® (indocyanine green) | Device | add-on fluorescence angiography |
Primary outcome
Comparison between the position of perforator flap determined by fluorescence angiography and the real anatomic position of the flap determined after dissection
Time frame: During the first fluorescent angiography
For each flap, the position of the flap determined by fluorescent angiography will be compared with the anatomic position (actual) determined on the relevant flap after dissection (gold standard).
3 secondary outcomes
Comparison between the position of the perforator flap determined by fluorescence angiography and the position of the flap determined by reference imaging techniques relevant to the flap (CT angiography or doppler ultrasonography)
Time frame: During the first fluorescent angiography
Intraoperative monitoring of the quality of micro-vascular anastomoses using fluorescent angiography
Time frame: Just after micro-vascular anastomoses
Postoperative monitoring of flap perfusion using fluorescence angiography
Time frame: Every six hours for four days after surgery
Results and safety
The study was stopped early (reason given: The study was stopped due to lack of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Background: PubMed 20210462Koenig A, Herve L, Gonon G, Josserand V, Berger M, Dinten JM, Boutet J, Peltie P, Coll JL, Rizo P. Fluorescence diffuse optical tomography for free-space and multifluorophore studies. J Biomed Opt. 2010 Jan-Feb;15(1):016016. doi: 10.1117/1.3309738.
Related trials for Reconstructive Surgery
RecruitingObservational study
Leica Microsystems Sponsored Study to Collect and Confirm Clinical Data on the Performance of the GLOW800 Device When Used in Accordance With Its Intended Use.
Reconstructive Surgical Procedures, Plastic Surgery
Not yet recruitingObservational study
Flap Assessment With Regional Oximetry for Early Detection of Compromise in Free Flap Reconstructive Surgery - FLARE Study
Reconstructive Surgery, Flap Monitoring
Recruiting
Study and Modeling of Perforator Flap Vascularization
Reconstructive Surgery Using Pedicled Perforating or Free Perforating Flaps, Pelvic Eschar
Not yet recruiting
App-Assisted Swallowing Program After Oral Cancer Surgery
Oral Cancer, Reconstructive Surgery
RecruitingObservational study
Postoperative Management of Patients Undergoing Head and Neck Microvascular Free Flap Reconstructive Surgery: is Admission to an Intensive Care Unit Necessary?
Reconstructive Surgery, Head and Neck Microvascular Free Flap
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.
Georges BETTEGA, MD, PHD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluorescence angiography (Fluobeam™ imaging system developed by Fluoptics company) in people with Reconstructive Surgery, run by University Hospital, Grenoble at 1 site in France.
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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 18 Apr 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 France. 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?
The study was stopped early (reason given: The study was stopped due to lack of inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between the position of perforator flap determined by fluorescence angiography and the real anatomic position of the flap determined after dissection (time frame: During the first fluorescent angiography). 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 NCT01681797, 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 18 Apr 2019; AzTrials last refreshed its copy on 8 Nov 2026.