Clinical trial NCT05068687: Peroperative Assessment of Malignancies of the Head and Neck Using High-resolution 18F-FDG-PET/CT
Official title: Peroperative Assessment of Tumour Resection Margins Using High-resolution 18F-FDG-PET/CT in Malignancies of the Head and Neck, a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Neoplasms
Thyroid Neoplasm
Skin Neoplasm
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: XEOS Medical
First posted: 2021-10-06
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Determine margin status in malignancies of the head and neck
timeFrame: 1 week after administration
Secondary outcomes:
measure: Characterize the ideal activity of 18F-FDG
timeFrame: During data-analysis
measure: Identify positive lymph nodes using 18F-FDG PET/CT
timeFrame: 1 week after administration
measure: Correlate distribution of 18F-FDG with histopathology
timeFrame: 1 day after administration
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Wouter Huvenne, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Debacker JM, Schelfhout V, Brochez L, Creytens D, D'Asseler Y, Deron P, Keereman V, Van de Vijver K, Vanhove C, Huvenne W. High-Resolution 18F-FDG PET/CT for Assessing Three-Dimensional Intraoperative Margins Status in Malignancies of the Head and Neck, a Proof-of-Concept. J Clin Med. 2021 Aug 22;10(16):3737. doi: 10.3390/jcm10163737.