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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04222543

Acronym

PIVOT

Enrollment

Registered

2020-01-10

Start date

2019-11-22

Completion date

2023-09-01

Last updated

2020-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oropharyngeal Squamous Cell Carcinoma

Keywords

Tumour microenvironment, Chemoradiotherapy, Oropharyngeal squamous cell carcinoma, Human papilloma virus, Positron emission tomography

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.

Interventions

COMBINATION_PRODUCTRGD PET/CT

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Differences in CT perfusion parameters between the pre- and per-treatment scan	1 month	Determining the blood volume using ROIs of the tumour drawn on the contrast enhanced CT
Differences in CT perfusion flow parameters between HPV positive and negative tumours	1 month	Determining the blood flow using ROIs of the tumour drawn on the contrast enhanced CT
Differences in CT perfusion parameters between HPV positive and negative tumours	1 month	Determining the blood volume using ROIs of the tumour drawn on the contrast enhanced CT
Differences in CT perfusion flow parameters between the pre- and per-treatment scan	1 month	Determining the blood flow using ROIs of the tumour drawn on the contrast enhanced CT
Differences in RGD-tracer uptake between HPV positive and negative tumours	1 month	standardized uptake values (SUV) of Ga68-RGD
Differences in RGD-tracer uptake between the pre- and per-treatment scan	1 month	standardized uptake values (SUV) of Ga68-RGD

Secondary

Measure	Time frame	Description
Differences in CT perfusion flow parameters between patients with locoregional control or recurrence within one year	1 year	Determining the blood flow using ROIs of the tumour drawn on the contrast enhanced CT
Differences in CT perfusion parameters between patients with locoregional control or recurrence within one year	1 year	Determining the blood volume using ROIs of the tumour drawn on the contrast enhanced CT
Differences in RGD-tracer uptake between patients with locoregional control or recurrence within one year	1 year	standardized uptake values (SUV) of Ga68-RGD

Countries

Netherlands

Contacts

Primary ContactE Aarntzen, MD, PhD

Erik.Aarntzen@radboudumc.nl+31243614048

Backup ContactD Lobeek