Overview
Sponsor-declared trial summary
Head and neck cancer
The primary objective is to compare the incidence of partial flap loss requiring surgical intervention within 1 month between patients undergoing intraoperative ICG angiography and those assessed using standard clinical methods.
Key facts
- Sponsor
- Region Skane
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Otorhinolaryngologic Diseases [C09], Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Decision date (initial)
- 2026-05-22
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Department of Plastic Surgery, Skåne University Hospital · Clinical Sciences, Lund University, Malmö, Sweden
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
The primary objective is to compare the incidence of partial flap loss requiring surgical intervention within 1 month between patients undergoing intraoperative ICG angiography and those assessed using standard clinical methods.
Secondary objectives 5
- Flap loss within one month.
- Flap related re-exploration rate in general anaesthesia within one month.
- Flap salvage rate within one month.
- Postoperative complications (graded according to the Clavien-Dindo classification) within three months.
- Association between intraoperative SPY-Q perfusion values and partial flap loss within 30 days, assessed using quantitative perfusion measurements derived from intraoperative indocyanine green fluorescence angiography.
Conditions and MedDRA coding
Head and neck cancer
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Intraoperative perfusion assessment period Intraoperative assessment of free flap perfusion during index head and neck reconstruction surgery using either standard clinical assessment or indocyanine green fluorescence angiography according to randomised allocation.
|
Randomised Controlled | None | Indocyanine green fluorescence angiography: Intervention arm Standard clinical assessment of flap perfusion: Control arm |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- To be included in the trial, subjects must meet all of the following criteria: 1) The subject is able to provide informed consent to the trial. 2) The subject is above 18 years of age. 3) The subject will undergo microvascular free flap reconstruction for oncologic or traumatic head and neck defects.
Exclusion criteria 1
- Subjects meeting any of the following criteria will be excluded: 1) The subject is allergic to indocyanine green or iodine 2) The subject has severe hepatic or renal impairment 3) The subject is pregnant
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint is incidence of partial flap loss requiring surgical intervention within 1 month.
Secondary endpoints 1
- The secondary endpoints of this trial are total flap loss, flap related re-exploration rate in general anaesthesia and flap salvage rate within one month, and postoperative complications (graded according to the Clavien-Dindo classification) within three months.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Verdye 5 mg/ml pulver till injektionsvätska, lösning
PRD10910178 · Product
- Active substance
- Indocyanine Green
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 75 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V04CX01 — -
- Marketing authorisation
- 21154
- MA holder
- DIAGNOSTIC GREEN LIMITED
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Skane
- Sponsor organisation
- Region Skane
- Address
- Dockplatsen 26, Malmo S:t Petri Malmo S:t Petri
- City
- Malmo
- Postcode
- 211 74
- Country
- Sweden
Scientific contact point
- Organisation
- Region Skane
- Contact name
- Sektion Plastik, SUS
Public contact point
- Organisation
- Region Skane
- Contact name
- Sektion Plastik, SUS
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Authorised, recruitment pending | 244 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements PR140226 | 1 |
| Subject information and informed consent form (for publication) | Information till fp och samtycke | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Verdye | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-04-10 | Sweden | Acceptable 2026-05-22
|
2026-05-22 |