Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Skin Neoplasm | Skin Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Thyroid Neoplasm | Thyroid Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| high-resolution PET-CT specimen imaging. | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- intraoperative high-resolution PET-CT imaging of resected malignancy
- interventionNames
- Diagnostic Test: high-resolution PET-CT specimen imaging.
Primary outcomes (1)
- measure
- Determine margin status in malignancies of the head and neck
- timeFrame
- 1 week after administration
- description
- 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 outcomes (3)
- measure
- Characterize the ideal activity of 18F-FDG
- timeFrame
- During data-analysis
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- RESULTDebacker 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. PMID 34442033
- DERIVEDDebacker JM, Maris L, Cordier F, Creytens D, Deron P, Descamps B, D'Asseler Y, De Man K, Keereman V, Libbrecht S, Schelfhout V, Van de Vijver K, Vanhove C, Huvenne W. Direct co-registration of [18F]FDG uptake and histopathology in surgically excised malignancies of the head and neck: a feasibility study. Eur J Nucl Med Mol Imaging. 2023 Jun;50(7):2127-2139. doi: 10.1007/s00259-023-06153-z. Epub 2023 Mar 1. PMID 36854863