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

January 6, 2020 updated by: Radboud University Medical Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands
        • Recruiting
        • Radboudumc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: HPV Negative tumours
Patients will receive four scans.
Combination product: RGD PET/CT
Patients will receive an RGD PET/CT and a CT perfusion scan prior to treatment and during chemoradiotherapy
Other Names:
  • CT perfusion
Active Comparator: HPV positive tumours
Patients will receive four scans.
Combination product: RGD PET/CT
Patients will receive an RGD PET/CT and a CT perfusion scan prior to treatment and during chemoradiotherapy
Other Names:
  • CT perfusion

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2019

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

November 20, 2019

First Submitted That Met QC Criteria

January 6, 2020

First Posted (Actual)

January 10, 2020

Study Record Updates

Last Update Posted (Actual)

January 10, 2020

Last Update Submitted That Met QC Criteria

January 6, 2020

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL69928.091.19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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