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The purpose of this study is to evaluate the diagnostic performance of 18F-FDG micro-PET-CT in malignant Head and neck cancer compared to definitive histological analysis (gold standard).
In approximately 20% of cases, surgical margins are considered insufficient. The only tool currently available intraoperatively to assess the quality of surgical resection is the extemporaneous examination. This has a sensitivity of only 10%.
The objective is therefore to evaluate the performance of another tool, available intraoperatively, to help surgeons assess the quality of their resection. Currently, micro-PET-CT allows for the evaluation of surgical specimens (CE marking and FDA approval obtained). Its performance in the evaluation of surgical margins remains to be demonstrated. This is the subject of the present study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | PET/CT of the specimen after surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| micro PET/CT | Device | PET/T of the speciment after surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the diagnostic performance of 18F-FDG micro-PET-CT in malignant ENT tumors compared to definitive histological analysis (gold standard). | Estimate the performance of micro-FDG PET in defining surgical margins and compare with histology by measuring the number of quadrants affected by each technique on the surgical specimen | Surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise-Marie Roussel, MD | Contact | +33232082222 | lise-marie.roussel@chb.unicancer.fr | |
| Doriane Richard, PhD | Contact | +33232082985 | doriane.richard@chb.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| Sebastien Hapdey, PhD | Centre Henri Becquerel | Principal Investigator |
| Lise-Marie Roussel, MD | Centre Henri Becquerel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Henri Becquerel | Recruiting | Rouen | France |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000072662 | Margins of Excision |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D065308 | Morphological and Microscopic Findings |
| D013568 | Pathological Conditions, Signs and Symptoms |
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