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

Radboud University Medical Center

Status and phase: Unknown; Phase 2

Conditions: Oropharyngeal Squamous Cell Carcinoma

Treatments: Combination Product: RGD PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT04222543

NL69928.091.19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

HPV Negative tumours

Active Comparator group

Description:

Patients will receive four scans.

Treatment:

Combination Product: RGD PET/CT

HPV positive tumours

Active Comparator group

Description:

Patients will receive four scans.

Treatment:

Combination Product: RGD PET/CT