SALVADS-Fluo: Interest of Fluorescence in Salvage Surgery for Recurrence of Head and Neck Cancer in Irradiated Area

Sponsor

Institut de Cancérologie de Lorraine (Other)

Overall Status

Completed

CT.gov ID

NCT02920216

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Drug: indocyanine green	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Dec 6, 2016

Actual Primary Completion Date :

Aug 10, 2017

Actual Study Completion Date :

Sep 6, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: eligible patient for a salvage surgery	Drug: indocyanine green intravenous injection of Indocyanine Green (0,25mg/kg) before surgery.

Arm

Intervention/Treatment

Experimental: eligible patient for a salvage surgery

Drug: indocyanine green

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

Outcome Measures

Primary Outcome Measures

Sensitivity of indocyanine green labeling in Irradiated Area [1 day]
The indocyanine green labeling in irradiated areas will be compared to the histological result on the surgical specimen.

Secondary Outcome Measures

Sensitivity of indocyanine green labeling on surgical margins [1 day]
The indocyanine green labeling on surgical margins will be compared to the surgical margins histological result

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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