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

Oropharyngeal Squamous Cell Carcinoma Clinical Trial

— PIVOT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04222543
• Other study ID #: NL69928.091.19
• Status: Recruiting
• Phase: Phase 2
• Start date: November 22, 2019
• Est. completion date: September 1, 2023

Study information

• Verified date: November 2019
• Source: Radboud University
• Contact: E Aarntzen, MD, PhD
• Phone: +31243614048
• Email: Erik.Aarntzen[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Oropharyngeal Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

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

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in RGD-tracer uptake between HPV positive and negative tumours	standardized uptake values (SUV) of Ga68-RGD	1 month
Primary	Differences in RGD-tracer uptake between the pre- and per-treatment scan	standardized uptake values (SUV) of Ga68-RGD	1 month
Primary	Differences in CT perfusion flow parameters between HPV positive and negative tumours	Determining the blood flow using ROIs of the tumour drawn on the contrast enhanced CT	1 month
Primary	Differences in CT perfusion parameters between HPV positive and negative tumours	Determining the blood volume using ROIs of the tumour drawn on the contrast enhanced CT	1 month
Primary	Differences in CT perfusion flow parameters between the pre- and per-treatment scan	Determining the blood flow using ROIs of the tumour drawn on the contrast enhanced CT	1 month
Primary	Differences in CT perfusion parameters between the pre- and per-treatment scan	Determining the blood volume using ROIs of the tumour drawn on the contrast enhanced CT	1 month
Secondary	Differences in RGD-tracer uptake between patients with locoregional control or recurrence within one year	standardized uptake values (SUV) of Ga68-RGD	1 year
Secondary	Differences in CT perfusion flow parameters between patients with locoregional control or recurrence within one year	Determining the blood flow using ROIs of the tumour drawn on the contrast enhanced CT	1 year
Secondary	Differences in CT perfusion parameters between patients with locoregional control or recurrence within one year	Determining the blood volume using ROIs of the tumour drawn on the contrast enhanced CT	1 year