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Known risk factors inducing squamous cell carcinomas of the head and neck are tabacco and alcohol intake. However, the incidence of human papillomavirus (HPV) related oropharyngeal carcinomas is increasing. It is known that HPV+ and HPV- tumors have a different reaction to (chemo)radiotherapy. The exact mechanisms underlying these differences is not yet known but might be caused by changes in vascularity. Therefore the vasculature is imaged with the help of a study specific Gallium-68-DOTA-(RGD)2 PET/CT scan and a CT perfusion scan.
The incidence of Human Papilloma Virus positive (HPV+) oropharyngeal Head and Neck Squamous Cell Carcinoma (HNSCC) is rising and it has become evident that this type of cancer represents a subgroup of HNSCC that is characterized by a more favourable prognosis, mediated by a distinct tumour microenvironment, compared to patients with HPV negative (HPV-) tumours. However, the exact mechanisms underlying this improved treatment outcome and the potential role of the tumour microenvironment are not fully understood yet. Imaging of αvβ3 integrin expression will obtain more insight in the differences in tumour microenvironment between HPV+ and HPV- oropharyngeal HNSCC. CT perfusion provides additional characterisation of this tumour microenvironment. Therefore, these techniques may have the potential to predict response to treatment and might possibly steer treatment decisions in future clinical trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPV Negative tumours | Active Comparator | Patients will receive four scans. |
|
| HPV positive tumours | Active Comparator | Patients will receive four scans. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RGD PET/CT | Combination Product | Patients will receive an RGD PET/CT and a CT perfusion scan prior to treatment and during chemoradiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Differences in RGD-tracer uptake between HPV positive and negative tumours | standardized uptake values (SUV) of Ga68-RGD | 1 month |
| Differences in RGD-tracer uptake between the pre- and per-treatment scan | standardized uptake values (SUV) of Ga68-RGD | 1 month |
| Differences in CT perfusion flow parameters between HPV positive and negative tumours | Determining the blood flow using ROIs of the tumour drawn on the contrast enhanced CT | 1 month |
| Differences in CT perfusion parameters between HPV positive and negative tumours | Determining the blood volume using ROIs of the tumour drawn on the contrast enhanced CT | 1 month |
| Differences in CT perfusion flow parameters between the pre- and per-treatment scan | Determining the blood flow using ROIs of the tumour drawn on the contrast enhanced CT | 1 month |
| Differences in CT perfusion parameters between the pre- and per-treatment scan | Determining the blood volume using ROIs of the tumour drawn on the contrast enhanced CT | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in RGD-tracer uptake between patients with locoregional control or recurrence within one year | standardized uptake values (SUV) of Ga68-RGD | 1 year |
| Differences in CT perfusion flow parameters between patients with locoregional control or recurrence within one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| E Aarntzen, MD, PhD | Contact | +31243614048 | Erik.Aarntzen@radboudumc.nl | |
| D Lobeek | Contact | +31243614048 | Erik.Aarntzen@radboudumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboudumc | Recruiting | Nijmegen | Gelderland | Netherlands |
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D003570 | Cytidine Triphosphate |
| ID | Term |
|---|---|
| D003597 | Cytosine Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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Imaging results of HPV positive tumours are compared to imaging results of HPV negative tumours.
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|
Determining the blood flow using ROIs of the tumour drawn on the contrast enhanced CT |
| 1 year |
| Differences in CT perfusion parameters between patients with locoregional control or recurrence within one year | Determining the blood volume using ROIs of the tumour drawn on the contrast enhanced CT | 1 year |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D006571 |
| Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |