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

NCT02920216 | Completed

• 1 other identifier: 2016-A00014-47
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

Head and Neck Neoplasms; Recurrence; Indocyanine Green; Salvage surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Sensitivity of indocyanine green labeling on surgical margins

  1 day

Study Arms (1)

eligible patient for a salvage surgery

EXPERIMENTAL

Drug: indocyanine green

Interventions

indocyanine green DRUG

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

eligible patient for a salvage surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de Cancérologie de Lorraine: lead

Study Sites (1)

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

Related 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.

  PMID: 32479902 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms; Recurrence

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• CORTESE Sophie, MD

  Institut de Cancérologie de Lorraine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: September 30, 2016
• Study Start: December 6, 2016
• Primary Completion: August 10, 2017
• Study Completion: September 6, 2017
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)