Clinical trial NCT04222543: Imaging of Tumour Microenvironment in Patients With Oropharyngeal Head and Neck Squamous Cell Carcinoma Using RGD PET/CT Imaging
Official title: Imaging of Tumour Microenvironment in Patients With Oropharyngeal Head and Neck Squamous Cell Carcinoma Using RGD PET/CT Imaging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Oropharyngeal Squamous Cell Carcinoma
Keywords: Tumour microenvironment
Chemoradiotherapy
Oropharyngeal squamous cell carcinoma
Human papilloma virus
Positron emission tomography
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2020-01-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Imaging results of HPV positive tumours are compared to imaging results of HPV negative tumours.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Proven squamous cell carcinoma of the oropharynx
* p-16 immunohistochemistry analysis
* Tumour lesion of at least 1.0 cm in diameter
* Planned chemoradiotherapy as primary treatment
* Ability to provide written informed consent

Exclusion Criteria:

* Contra-indications for PET
* Contra-indications for administration of iodine-containing contrast agents
* Other serious illness that can affect the scans

Primary outcomes:
measure: Differences in RGD-tracer uptake between HPV positive and negative tumours
timeFrame: 1 month
measure: Differences in RGD-tracer uptake between the pre- and per-treatment scan
timeFrame: 1 month
measure: Differences in CT perfusion flow parameters between HPV positive and negative tumours
timeFrame: 1 month
measure: Differences in CT perfusion parameters between HPV positive and negative tumours
timeFrame: 1 month
measure: Differences in CT perfusion flow parameters between the pre- and per-treatment scan
timeFrame: 1 month
measure: Differences in CT perfusion parameters between the pre- and per-treatment scan
timeFrame: 1 month
Secondary outcomes:
measure: Differences in RGD-tracer uptake between patients with locoregional control or recurrence within one year
timeFrame: 1 year
measure: Differences in CT perfusion flow parameters between patients with locoregional control or recurrence within one year
timeFrame: 1 year
measure: Differences in CT perfusion parameters between patients with locoregional control or recurrence within one year
timeFrame: 1 year
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
References: