Head and Neck NeoplasmsNCT05068687
Peroperative Assessment of Malignancies of the Head and Neck Using High-resolution 18F-FDG-PET/CT
A study testing high-resolution PET-CT specimen imaging. in people with Head and Neck Neoplasms and Thyroid Neoplasm, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms, Thyroid Neoplasm, Skin Neoplasm
- What is being tested?
- high-resolution PET-CT specimen imaging.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Aug 2020to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- high-resolution PET-CT specimen imaging.
- Medical subject headings
- Head and Neck Neoplasms, Thyroid Neoplasms, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| intraoperative high-resolution PET-CT imaging of resected malignancy | Experimental | Not described Receives: Diagnostic Test: high-resolution PET-CT specimen imaging. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week after administration
Secondary outcomes (3)
Characterize the ideal activity of 18F-FDG
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.
Measured: During data-analysis
Identify positive lymph nodes using 18F-FDG PET/CT
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.
Measured: 1 week after administration
Correlate distribution of 18F-FDG with histopathology
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.
Measured: 1 day after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start28 Aug 2020
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- XEOS Medical
- Responsible party
- Sponsor
- Investigators
- Wouter Huvenne, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068687
- Sponsor's protocol ID
- BC-05493
- Status last verified
- Sep 2021
- First submitted
- 24 Sep 2021
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34442033Debacker 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.
PubMed 36854863
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05068687
- Acronym / sponsor ID
- BC-05493
- Conditions
- Head and Neck Neoplasms, Thyroid Neoplasm, Skin Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- XEOS Medical
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intraoperative high-resolution PET-CT imaging of resected malignancy | Experimental | Diagnostic Test: high-resolution PET-CT specimen imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | intraoperative high-resolution PET-CT imaging of resected malignancy |
Primary outcome
Determine margin status in malignancies of the head and neck
Time frame: 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.
3 secondary outcomes
Characterize the ideal activity of 18F-FDG
Time frame: During data-analysis
Identify positive lymph nodes using 18F-FDG PET/CT
Time frame: 1 week after administration
Correlate distribution of 18F-FDG with histopathology
Time frame: 1 day after administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Results publication: PubMed 34442033Debacker 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.
- Derived from this study: PubMed 36854863Debacker 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.
Related trials for Head and Neck Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wouter Huvenne, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high-resolution PET-CT specimen imaging. in people with Head and Neck Neoplasms and Thyroid Neoplasm, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine margin status in malignancies of the head and neck (time frame: 1 week after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05068687, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.