Clinical trial NCT02920216: Interest of Fluorescence in Salvage Surgery for Recurrence of Head and Neck Cancer in Irradiated Area
Official title: Pilot Study of Evaluation of the Interest of Fluorescence in Salvage Surgery for Recurrence of Head and Neck Cancer in Irradiated Area
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Head and Neck Neoplasms
Recurrence
Indocyanine Green
Salvage surgery
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2016-09-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of indocyanine green labeling in Irradiated Area
timeFrame: 1 day
Secondary outcomes:
measure: Sensitivity of indocyanine green labeling on surgical margins
timeFrame: 1 day
Other outcomes:
Locations:
city: Vandoeuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
Study officials:
affiliation: Institut de Cancérologie de Lorraine
name: CORTESE Sophie, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cortese S, Kerrien E, Yakavets I, Meilender R, Mastronicola R, Renard S, Leroux A, Bezdetnaya L, Dolivet G. ICG-induced NIR fluorescence mapping in patients with head & neck tumors after the previous radiotherapy. Photodiagnosis Photodyn Ther. 2020 Sep;31:101838. doi: 10.1016/j.pdpdt.2020.101838. Epub 2020 May 30.