NCT05068687

Peroperative Assessment of Malignancies of the Head and Neck Using High-resolution 18F-FDG-PET/CT

Peroperative Assessment of Tumour Resection Margins Using High-resolution 18F-FDG-PET/CT in Malignancies of the Head and Neck, a Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study, patients diagnosed with a pathology-proven malignancy of the head and neck will receive a routine clinical activity of 18F-FDG ((18)F-luorodeoxyglucose) before undergoing standard of care surgical resection of the malignancy. Following the resection, the 18F-FDG-infused malignancy will be investigated utilizing a novel high-resolution Positron Emission Tomography (PET) and Computed Tomography (CT) scan. Slicing of the malignancy will be followed by additional PET/CT-scanning and autoradiography of the sliced specimen. The results found during image analysis will be compared to the results of the gold standard of histopathology. As this is no approved way of assessing the tumour's margin, the conclusion of the scan will not be used as a method for changing the patients' treatment.

Conditions

• Head and Neck Neoplasms
• Thyroid Neoplasm
• Skin Neoplasm

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	high-resolution PET-CT specimen imaging.	Included patients are given a single weight-dependent activity of 18F-FDG at the department of Nuclear Medicine. After administration, patients are brought to the operating room where standard of care surgical removal of the malignancy is performed. The resected specimen(s) are brought to the imaging lab and scanned using a preclinical and/or a dedicated specimen PET/CT device. Following PET/CT imaging, the specimen is brought to the department of pathology, where it is sliced. Some of these slices are then rescanned using the preclinical PET/CT device. Moreover, frozen sections are made from one of these slices with macroscopically visible malignant tissue and placed on an autoradiograph overnight. Finally, the imaging results are then correlated to the results found during histopathological analysis of the specimens.

Timeline

• Start date: 2020-08-28
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2021-10-06
• Last updated: 2022-11-30

Locations

1 site across 1 country: Belgium