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

Head and Neck Cancer Clinical Trial

— SALVADS-Fluo  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02920216
• Other study ID #: 2016-A00014-47
• Status: Completed
• Phase: N/A
• Start date: December 6, 2016
• Est. completion date: September 6, 2017

Study information

• Verified date: March 2022
• Source: Institut de Cancérologie de Lorraine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 6, 2017
• Est. primary completion date: August 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Recurrence

Intervention

Drug:
• indocyanine green
intravenous injection of Indocyanine Green (0,25mg/kg) before surgery.

Locations

Country	Name	City	State
France	Institut de Cancérologie de Lorraine	Vandoeuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de Lorraine

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of indocyanine green labeling in Irradiated Area	The indocyanine green labeling in irradiated areas will be compared to the histological result on the surgical specimen.	1 day
Secondary	Sensitivity of indocyanine green labeling on surgical margins	The indocyanine green labeling on surgical margins will be compared to the surgical margins histological result	1 day