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

Not Applicable

Completed

• Conditions: Head and Neck Cancer
• Interventions: Drug: indocyanine green

• Registration Number: NCT02920216
• Lead Sponsor: Institut de Cancérologie de Lorraine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-21
• Study First Submitted QC: 2016-09-28
• Study First Posted: 2016-09-30
• Study Start: 2016-12-06
• Primary Completion: 2017-08-10
• Study Completion: 2017-09-06
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-29
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
eligible patient for a salvage surgery	indocyanine green	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Institut de Cancérologie de Lorraine; 🇫🇷 Vandoeuvre-lès-Nancy, France