Head and Neck Cancer (H&N)Phase 4VISIONNCT07635420
Comparing Intraoperative Indocyanine Green Fluorescence Imaging With Standard Clinical Assessment for Flap Perfusion in Head and Neck Reconstruction (VISION Trial)
A Phase 4 study testing Indocyanine Green and Standard clinical perfusion assessment in people with Head and Neck Cancer (H&N) and Free Tissue Flaps, run by Region Skane at 1 site in Sweden.
Trial summary
This is a prospective multicentre randomised controlled trial evaluating whether intraoperative indocyanine green (ICG) fluorescence angiography improves outcomes in head and neck free flap reconstruction compared with standard clinical assessment of flap perfusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer (H&N), Free Tissue Flaps, Free Flap
- What is being tested?
- Indocyanine Green and Standard clinical perfusion assessment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteSweden
- Study dates
- 28 Sep 2026to 1 Aug 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Age ≥18 years at the time of inclusion
- Scheduled to undergo microvascular free flap reconstruction as part of oncologic, trauma, or benign surgery in the head and neck area
- Ability to understand study information and provide written informed consent
Who cannot join
- Known allergy to indocyanine green or iodine
- Severe hepatic or renal impairment
- Confirmed or suspected pregnancy
- Breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Dept. of Plastic and Reconstructive Surgery and Dept. of Health Sciences, Skåne University Hospital, Malmö, Sweden.
Malmö
Pooya Rajabaleyan, MD, PhD, +4640331000, Pooya.r@hotmail.com
About this study
Official title: Comparing Intraoperative Indocyanine Green Fluorescence Imaging With Standard Clinical Assessment for Flap Perfusion in Head and Neck Reconstruction: A Randomised Controlled Trial (VISION Trial)
This is a prospective multicentre randomised controlled trial evaluating whether intraoperative indocyanine green (ICG) fluorescence angiography improves outcomes in head and neck free flap reconstruction compared with standard clinical assessment of flap perfusion. Adult patients undergoing microvascular free flap reconstruction for oncologic, trauma, or benign head and neck defects will be randomised to either intraoperative ICG angiography or conventional clinical perfusion assessment. The primary outcome is partial flap loss requiring intervention within 30 days after surgery. Secondary outcomes include total flap loss, flap-related re-exploration, flap salvage, and postoperative complications.
Read the detailed description
The VISION Trial is a prospective, multicentre, open-label, parallel-group randomised controlled trial comparing intraoperative indocyanine green (ICG) fluorescence angiography with standard clinical assessment for flap perfusion in head and neck free flap reconstruction.
Free flap reconstruction is an essential component of complex head and neck reconstruction, but flap survival depends on adequate microvascular perfusion. Conventional intraoperative assessment methods, including inspection of flap colour, capillary refill, tissue turgor, bleeding upon needle prick, and Doppler examination, provide indirect assessment of perfusion and may be unreliable in some situations.
ICG fluorescence angiography enables real-time visualisation of arterial inflow and venous outflow using near-infrared fluorescence imaging. Retrospective studies have suggested that ICG angiography may reduce rates of partial flap loss and flap-related re-exploration, but high-quality prospective randomised evidence remains limited.
A total of 244 adult patients undergoing microvascular free flap reconstruction for oncologic, trauma, or benign head and neck defects at participating Swedish centres will be included. Participants will be randomised to either standard clinical assessment alone or standard clinical assessment supplemented with intraoperative ICG fluorescence angiography.
In the intervention group, ICG angiography will be performed intraoperatively using near-infrared fluorescence imaging systems after administration of intravenous indocyanine green (Verdye®). Quantitative perfusion analysis will also be performed using SPY-Q software.
The primary endpoint is partial flap loss requiring intervention within 30 days after surgery. Secondary endpoints include total flap loss, flap-related re-exploration under general anaesthesia, flap salvage, postoperative complications graded according to Clavien-Dindo classification, and the association between intraoperative SPY-Q perfusion values and flap outcomes.
No additional trial-specific postoperative visits are required. Outcomes will be assessed through structured chart review at 30 and 90 days postoperatively.
- Conditions
- Head and Neck Cancer (H&N), Free Tissue Flaps, Free Flap, Free Flap Evaluation, Indocyanine Green, Indocyanine Green (ICG)
- Being tested
- Indocyanine Green, Standard clinical perfusion assessment
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine GreenDrug
Also called ICG, Verdye
Indocyanine green (ICG) is administered intravenously during surgery for intraoperative fluorescence angiography assessment of free flap perfusion in head and neck reconstruction. A 25 mg vial of ICG (Verdye®) is reconstituted with sterile water, and approximately 7.5 mg is administered intravenously followed by saline flush. Perfusion is assessed using near-infrared fluorescence imaging systems and SPY-Q quantitative perfusion analysis.
Standard clinical perfusion assessmentProcedure or surgery
Standard intraoperative clinical assessment of free flap perfusion including evaluation of flap colour, capillary refill, tissue turgor, bleeding upon needle prick, and Doppler examination as clinically indicated during head and neck free flap reconstruction.
| Study group | Role | What they receive |
|---|---|---|
| Standard clinical assessment | Active comparator | Participants undergo intraoperative assessment of free flap perfusion using standard clinical assessment methods, including inspection of flap colour, capillary refill, tissue turgor, bleeding upon needle prick, and Doppler examination as clinically indicated. Surgical revision is performed according to standard clinical practice if inadequate perfusion is suspected. Receives: Procedure: Standard clinical perfusion assessment |
| Indocyanine Green Fluorescence Angiography | Experimental | Participants undergo intraoperative assessment of free flap perfusion using indocyanine green (ICG) fluorescence angiography in addition to standard clinical assessment. ICG is administered intravenously and perfusion is evaluated using near-infrared fluorescence imaging and SPY-Q quantitative perfusion analysis during head and neck free flap reconstruction. Receives: Drug: Indocyanine Green; Procedure: Standard clinical perfusion assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partial flap loss requiring intervention
Partial flap loss is defined as clinically evident flap necrosis requiring active therapeutic intervention, including operative debridement/revision in the operating room or bedside debridement/trimming performed by a surgeon beyond routine wound care.
Measured: From index surgery to 30 days postoperatively
Secondary outcomes (5)
Total flap loss
Complete flap failure requiring flap removal, replacement, or abandonment with documentation of flap non-viability.
Measured: From index surgery to 30 days postoperatively
Flap-related re-exploration under general anaesthesia
Return to the operating room under general anaesthesia due to suspected or confirmed flap vascular compromise or flap viability concern, excluding planned second-look procedures without concern.
Measured: From index surgery to 30 days postoperatively
Flap salvage
Successful retention of the index flap following flap-related re-exploration for vascular compromise.
Measured: From index surgery to 30 days postoperatively
Postoperative complications
Incidence of postoperative complications occurring 90 days after index operation. Predefined surgical complications will be captured systematically and include surgical takeback, partial flap loss, total flap loss, infection, hematoma or bleeding requiring intervention, fistula formation, wound dehiscence, seroma, abnormal wound healing, and other surgical complications. The severity of complications will be classified according to the Clavien-Dindo Classification of Surgical Complications (Grade I-V, where Grade I represents the least severe complication and Grade V represents death).
Measured: From index surgery to 90 days postoperatively
Correlation between intraoperative SPY-Q Relative Perfusion Value (%) and partial flap loss
Correlation between intraoperative tissue perfusion measured using SPY-Q quantitative analysis software following indocyanine green fluorescence angiography and postoperative partial flap loss within 30 days after surgery. SPY-Q Relative Perfusion Value is reported as a percentage ranging from 0% to 100%, where higher values indicate greater tissue perfusion. Partial flap loss is assessed clinically and recorded as a binary outcome (present or absent). The outcome measure is the correlation coefficient between SPY-Q Relative Perfusion Value and partial flap loss.
Measured: From index surgery to 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start28 Sep 2026 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Cancer (H&N)Studies of the same condition, open and under way.
- More trials run by Region SkaneThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective multicentre open-label parallel-group randomised controlled trial comparing intraoperative indocyanine green fluorescence angiography with standard clinical assessment for flap perfusion in head and neck free flap reconstruction.
- Masking
- None (open label)
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pooya Rajabaleyan, MD, PhD, Principal investigator, Region Skåne, Skånes universitetssjukhus, Sektion Plastikkirurgi, Malmö, Sverige
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635420
- Sponsor's protocol ID
- 2025-524710-29-00
- Other IDs
- 2025-524710-29-00, 2025
- Acronym
- VISION
- Status last verified
- Sep 2026
- First submitted
- 28 May 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Intraoperative Indocyanine Green Fluorescence Imaging With Standard Clinical Assessment for Flap Perfusion in Head and Neck Reconstruction: A Randomised Controlled Trial (VISION Trial)
- ClinicalTrials.gov ID
- NCT07635420
- Acronym / sponsor ID
- VISION / 2025-524710-29-00
- Conditions
- Head and Neck Cancer (H&N), Free Tissue Flaps, Free Flap, Free Flap Evaluation, Indocyanine Green, Indocyanine Green (ICG)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 28 Sep 2026 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 9 Jun 2026 (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.
This is a prospective multicentre randomised controlled trial evaluating whether intraoperative indocyanine green (ICG) fluorescence angiography improves outcomes in head and neck free flap reconstruction compared with standard clinical assessment of flap perfusion. Adult patients undergoing microvascular free flap reconstruction for oncologic, trauma, or benign head and neck defects will be randomised to either intraoperative ICG angiography or conventional clinical perfusion assessment. The primary outcome is partial flap loss requiring intervention within 30 days after surgery. Secondary outcomes include total flap loss, flap-related re-exploration, flap salvage, and postoperative complications.
Detailed description
The VISION Trial is a prospective, multicentre, open-label, parallel-group randomised controlled trial comparing intraoperative indocyanine green (ICG) fluorescence angiography with standard clinical assessment for flap perfusion in head and neck free flap reconstruction.
Free flap reconstruction is an essential component of complex head and neck reconstruction, but flap survival depends on adequate microvascular perfusion. Conventional intraoperative assessment methods, including inspection of flap colour, capillary refill, tissue turgor, bleeding upon needle prick, and Doppler examination, provide indirect assessment of perfusion and may be unreliable in some situations.
ICG fluorescence angiography enables real-time visualisation of arterial inflow and venous outflow using near-infrared fluorescence imaging. Retrospective studies have suggested that ICG angiography may reduce rates of partial flap loss and flap-related re-exploration, but high-quality prospective randomised evidence remains limited.
A total of 244 adult patients undergoing microvascular free flap reconstruction for oncologic, trauma, or benign head and neck defects at participating Swedish centres will be included. Participants will be randomised to either standard clinical assessment alone or standard clinical assessment supplemented with intraoperative ICG fluorescence angiography.
In the intervention group, ICG angiography will be performed intraoperatively using near-infrared fluorescence imaging systems after administration of intravenous indocyanine green (Verdye®). Quantitative perfusion analysis will also be performed using SPY-Q software.
The primary endpoint is partial flap loss requiring intervention within 30 days after surgery. Secondary endpoints include total flap loss, flap-related re-exploration under general anaesthesia, flap salvage, postoperative complications graded according to Clavien-Dindo classification, and the association between intraoperative SPY-Q perfusion values and flap outcomes.
No additional trial-specific postoperative visits are required. Outcomes will be assessed through structured chart review at 30 and 90 days postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective multicentre open-label parallel-group randomised controlled trial comparing intraoperative indocyanine green fluorescence angiography with standard clinical assessment for flap perfusion in head and neck free flap reconstruction.
| Arm | Type | Receives |
|---|---|---|
| Standard clinical assessment | Active comparator | Procedure: Standard clinical perfusion assessmentParticipants undergo intraoperative assessment of free flap perfusion using standard clinical assessment methods, including inspection of flap colour, capillary refill, tissue turgor, bleeding upon needle prick, and Doppler examination as clinically indicated. Surgical revision is performed according to standard clinical practice if inadequate perfusion is suspected. |
| Indocyanine Green Fluorescence Angiography | Experimental | Drug: Indocyanine Green, Procedure: Standard clinical perfusion assessmentParticipants undergo intraoperative assessment of free flap perfusion using indocyanine green (ICG) fluorescence angiography in addition to standard clinical assessment. ICG is administered intravenously and perfusion is evaluated using near-infrared fluorescence imaging and SPY-Q quantitative perfusion analysis during head and neck free flap reconstruction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years at the time of inclusion
- Scheduled to undergo microvascular free flap reconstruction as part of oncologic, trauma, or benign surgery in the head and neck area
- Ability to understand study information and provide written informed consent
Key exclusion criteria (4 listed)
- Known allergy to indocyanine green or iodine
- Severe hepatic or renal impairment
- Confirmed or suspected pregnancy
- Breastfeeding
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 |
|---|---|---|
| Indocyanine GreenAlso: ICG, VerdyeIndocyanine green (ICG) is administered intravenously during surgery for intraoperative fluorescence angiography assessment of free flap perfusion in head and neck reconstruction. A 25 mg vial of ICG (Verdye®) is reconstituted with sterile water, and approximately 7.5 mg is administered intravenously followed by saline flush. Perfusion is assessed using near-infrared fluorescence imaging systems and SPY-Q quantitative perfusion analysis. | Drug | Indocyanine Green Fluorescence Angiography |
| Standard clinical perfusion assessmentStandard intraoperative clinical assessment of free flap perfusion including evaluation of flap colour, capillary refill, tissue turgor, bleeding upon needle prick, and Doppler examination as clinically indicated during head and neck free flap reconstruction. | Procedure or surgery | Indocyanine Green Fluorescence Angiography, Standard clinical assessment |
Primary outcome
Partial flap loss requiring intervention
Time frame: From index surgery to 30 days postoperatively
Partial flap loss is defined as clinically evident flap necrosis requiring active therapeutic intervention, including operative debridement/revision in the operating room or bedside debridement/trimming performed by a surgeon beyond routine wound care.
5 secondary outcomes
Total flap loss
Time frame: From index surgery to 30 days postoperatively
Flap-related re-exploration under general anaesthesia
Time frame: From index surgery to 30 days postoperatively
Flap salvage
Time frame: From index surgery to 30 days postoperatively
Postoperative complications
Time frame: From index surgery to 90 days postoperatively
Correlation between intraoperative SPY-Q Relative Perfusion Value (%) and partial flap loss
Time frame: From index surgery to 30 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Pooya Rajabaleyan, MD, PhD principal investigator
Region Skåne, Skånes universitetssjukhus, Sektion Plastikkirurgi, Malmö, Sverige
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Indocyanine Green and Standard clinical perfusion assessment in people with Head and Neck Cancer (H&N) and Free Tissue Flaps, run by Region Skane at 1 site in Sweden.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 29 Sep 2026. 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 Sweden. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pooya Rajabaleyan, MD, PhD (+4640331000, Pooya.r@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Partial flap loss requiring intervention (time frame: From index surgery to 30 days postoperatively). 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 29 Sep 2026.