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

Not Applicable

Completed

• Conditions: Thyroid Neoplasm; Skin Neoplasm; Head and Neck Neoplasms
• Interventions: Diagnostic Test: high-resolution PET-CT specimen imaging.

• Registration Number: NCT05068687
• Lead Sponsor: University Hospital, Ghent

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-28
• Status Verified: 2021-09
• Study First Submitted: 2021-09-24
• Study First Submitted QC: 2021-10-05
• Study First Posted: 2021-10-06
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Last Update Submitted: 2022-11-29
• Last Update Posted: 2022-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Patients with one or multiple pathologically proven malignancies in the head and neck region (targeted lesions), independent of origin and stage.
• Patient is planned for the surgical resection of the targeted lesion.
• Age ≥ 18 years.
• Karnofsky performance scale ≥30
• Patient has given informed consent according to the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines in accordance with the declaration of Helsinki.

Exclusion Criteria

• Patient is planned for a treatment regimen which does not include standard surgical resection of the targeted lesion.
• Pregnant or actively lactating women.
• Blood glucose level ≥ 200mg/dl or more on the day of surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intraoperative high-resolution PET-CT imaging of resected malignancy	high-resolution PET-CT specimen imaging.	-

Primary Outcome Measures

Name	Time	Method
Determine margin status in malignancies of the head and neck	1 week after administration	To investigate the ability of high-resolution 18F-FDG-PET/CT-scan to determine the margin status in malignancies of the head and neck. This will be compared to the gold standard of histopathological examination.

Secondary Outcome Measures

Name	Time	Method
Correlate distribution of 18F-FDG with histopathology	1 day after administration	To correlate the distribution of 18F-FDG in and around tumoral tissue with the histopathology of the specimen. This will be performed by correlating the results obtained from the PET/CT-scan of (sliced) tumoral specimens and autoradiography of a frozen section of the tumour.
Characterize the ideal activity of 18F-FDG	During data-analysis	The characterization of the ideal dose of 18F-FDG necessary for specimen imaging with a sufficient signal-to-noise ratio. This dose will be identified using post-processing image reconstruction on the specimen resulting from patients given a standard diagnostic activity of 18F-FDG.
Identify positive lymph nodes using 18F-FDG PET/CT	1 week after administration	To investigate the ability of high-resolution 18F-FDG-PET/CT to identify positive lymph nodes excised by neck dissection. This will be quantified as sensitivity and specificity compared to the gold standard of histopathological examination.

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium