NCT07285564

Performance of 18F-FDG Micro-PET-CT in the Assessment of Surgical Margins in Head and Neck Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Centre Henri Becquerel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Head & Neck Cancer

Interventions

Type	Name	Description
DEVICE	micro PET/CT	PET/T of the speciment after surgery

Timeline

• Start date: 2025-11-07
• Primary completion: 2026-03-15
• Completion: 2026-06-15
• First posted: 2025-12-16
• Last updated: 2025-12-16

Locations

1 site across 1 country: France