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

Phase 2

• Conditions: Oropharyngeal Squamous Cell Carcinoma
• Interventions: Combination Product: RGD PET/CT

• Registration Number: NCT04222543
• Lead Sponsor: Radboud University Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2019-11
• Study First Submitted: 2019-11-20
• Study Start: 2019-11-22
• Study First Submitted QC: 2020-01-06
• Last Update Submitted: 2020-01-06
• Study First Posted: 2020-01-10
• Last Update Posted: 2020-01-10
• Primary Completion: 2022-09-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HPV positive tumours	RGD PET/CT	Patients will receive four scans.
HPV Negative tumours	RGD PET/CT	Patients will receive four scans.

Primary Outcome Measures

Name	Time	Method
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
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 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

Secondary Outcome Measures

Name	Time	Method
Differences in RGD-tracer uptake between patients with locoregional control or recurrence within one year	1 year	standardized uptake values (SUV) of Ga68-RGD
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 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

Trial Locations

Locations (1)

Radboudumc; 🇳🇱 Nijmegen, Gelderland, Netherlands