Interest of Fluorescence in Salvage Surgery for Recurrence of Head and Neck Cancer in Irradiated Area

Treatment of Head and Neck Squamous cell carcinoma often combines chemoradiotherapy when organ has to be preserved or when surgery is not indicated. The loco-regional failure is about 30%. Then salvage surgery is the only chance for patients to survive but the overall survival rate is only 29% at 24 months. This prognostic is bad because of poor local control which is non-optimized by a complementary radiotherapy and negative exeresis margins.

Currently, there is no intraoperative technique to better visualize the tumor limits in real time. With fluorescence techniques, an accurate mapping of tumor extension can be considered. Recently, Atallah et al. (2015) demonstrated the use of fluorescence during a head and neck surgery in mice, as a tool allowing for better surgical margins. Digonnet et al (2015) found a tumor fragment after an injection of indocyanine green (ICG) intravenously in salvage surgery for patient with head and neck cancer.

The ability of ICG to detect a surgical margin positive intraoperatively has never be evaluated in irradiated area.

The aim of this pilot study is to evaluate the interest of fluorescence in salvage surgery for recurrence of head and neck cancer in irradiated area.

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Key information

Conditions

Head and Neck Cancer Disease Attributes Head and Neck Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient over 18 years old
Head and Neck Squamous Cell Carcinoma confirmed by biopsy
Non metastatic disease
Resectable tumour
Locoregional recurrence or new localization in pre irradiated territory at a dose ≥ 50 Gy with or without chemotherapy
Haematological constants, liver function and kidney function adapted in the 15 days before inclusion:

Haemoglobin ≥ 9 g / dL
Polymorphonuclear neutrophils ≥ 1.5 x 10 9
Platelet ≥ 100 x 109 / L
Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
ALT and AST <3 times ULN
Alkaline phosphatase ≤ 2.5 times ULN
Serum creatinine <110 mmol / L or creatinine clearance> 55 ml / min (method of Cockcroft)
Absence of proteinuria
WHO 0 or 1
Signed informed consent form
Patient affiliated to the social security system.

Exclusion criteria

Patient considered as non eligible for a salvage surgery
Metastatic disease
Hypersensitivity to indocyanine green or allergy to seafood or reaction to iodinated contrast agents
Pregnant or breastfeeding women

Treatment and study plan

Indocyanine green

Drug

intravenous injection of Indocyanine Green (0,25mg/kg) before surgery.

Primary outcomes

Sensitivity of indocyanine green labeling in Irradiated Area

Time frame: 1 day

The indocyanine green labeling in irradiated areas will be compared to the histological result on the surgical specimen.

Secondary outcomes

Sensitivity of indocyanine green labeling on surgical margins

Time frame: 1 day

The indocyanine green labeling on surgical margins will be compared to the surgical margins histological result

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Registry information

Official study title

Pilot Study of Evaluation of the Interest of Fluorescence in Salvage Surgery for Recurrence of Head and Neck Cancer in Irradiated Area

Acronym: SALVADS-Fluo

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Sep 30, 2016
Registry last updated: Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed