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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eligible patient for a salvage surgery | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| indocyanine green | Drug | intravenous injection of Indocyanine Green (0,25mg/kg) before surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
WHO 0 or 1
Signed informed consent form
Patient affiliated to the social security system.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| CORTESE Sophie, MD | Institut de Cancérologie de Lorraine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancérologie de Lorraine | Vandœuvre-lès-Nancy | 54519 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32479902 | Background | 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. |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |