Imaging of Tumour Microenvironment in Patients With Oropharyngeal Head and Neck Squamous Cell Carcinoma Using RGD PET/CT Imaging

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-22

Study Completion Date

2023-09-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Oropharyngeal Squamous Cell Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Imaging results of HPV positive tumours are compared to imaging results of HPV negative tumours.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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HPV Negative tumours

Patients will receive four scans.

Group Type ACTIVE_COMPARATOR

RGD PET/CT

Intervention Type COMBINATION_PRODUCT

Patients will receive an RGD PET/CT and a CT perfusion scan prior to treatment and during chemoradiotherapy

HPV positive tumours

Patients will receive four scans.

Group Type ACTIVE_COMPARATOR

RGD PET/CT

Intervention Type COMBINATION_PRODUCT

Patients will receive an RGD PET/CT and a CT perfusion scan prior to treatment and during chemoradiotherapy

Interventions

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RGD PET/CT

Patients will receive an RGD PET/CT and a CT perfusion scan prior to treatment and during chemoradiotherapy

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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CT perfusion

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No