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

NCT05068687 | Completed

• 1 other identifier: BC-05493
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Neoplasms; Thyroid Neoplasm; Skin Neoplasm

Outcome Measures

Primary Outcomes (1)

• Determine margin status in malignancies of the head and neck

  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.

  1 week after administration

Secondary Outcomes (3)

• Characterize the ideal activity of 18F-FDG

  During data-analysis

• Identify positive lymph nodes using 18F-FDG PET/CT

  1 week after administration

• Correlate distribution of 18F-FDG with histopathology

  1 day after administration

Study Arms (1)

intraoperative high-resolution PET-CT imaging of resected malignancy

EXPERIMENTAL

Diagnostic Test: high-resolution PET-CT specimen imaging.

Interventions

high-resolution PET-CT specimen imaging. DIAGNOSTIC_TEST

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.

intraoperative high-resolution PET-CT imaging of resected malignancy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead
• XEOS Medical: collaborator

Study Sites (1)

Ghent University Hospital

Ghent, B-9000, Belgium

Location

Related Publications (2)

• 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.

  PMID: 34442033 RESULT

• Debacker 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 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Thyroid Neoplasms; Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Endocrine System Diseases; Thyroid Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Wouter Huvenne, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: October 6, 2021
• Study Start: August 28, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: November 30, 2022

Record last verified: 2021-09

Locations

BE (1)