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

Primary Purpose

Oropharyngeal Squamous Cell Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
RGD PET/CT
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Oropharyngeal Squamous Cell Carcinoma focused on measuring Tumour microenvironment, Chemoradiotherapy, Oropharyngeal squamous cell carcinoma, Human papilloma virus, Positron emission tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • RadboudumcRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

HPV Negative tumours

HPV positive tumours

Arm Description

Patients will receive four scans.

Patients will receive four scans.

Outcomes

Primary Outcome Measures

Differences in RGD-tracer uptake between HPV positive and negative tumours
standardized uptake values (SUV) of Ga68-RGD
Differences in RGD-tracer uptake between the pre- and per-treatment scan
standardized uptake values (SUV) of Ga68-RGD
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
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
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
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

Secondary Outcome Measures

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

Full Information

First Posted
November 20, 2019
Last Updated
January 6, 2020
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04222543
Brief Title
Imaging of Tumour Microenvironment in Patients With Oropharyngeal Head and Neck Squamous Cell Carcinoma Using RGD PET/CT Imaging
Acronym
PIVOT
Official Title
Imaging of Tumour Microenvironment in Patients With Oropharyngeal Head and Neck Squamous Cell Carcinoma Using RGD PET/CT Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 22, 2019 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oropharyngeal Squamous Cell Carcinoma
Keywords
Tumour microenvironment, Chemoradiotherapy, Oropharyngeal squamous cell carcinoma, Human papilloma virus, Positron emission tomography

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Imaging results of HPV positive tumours are compared to imaging results of HPV negative tumours.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HPV Negative tumours
Arm Type
Active Comparator
Arm Description
Patients will receive four scans.
Arm Title
HPV positive tumours
Arm Type
Active Comparator
Arm Description
Patients will receive four scans.
Intervention Type
Combination Product
Intervention Name(s)
RGD PET/CT
Other Intervention Name(s)
CT perfusion
Intervention Description
Patients will receive an RGD PET/CT and a CT perfusion scan prior to treatment and during chemoradiotherapy
Primary Outcome Measure Information:
Title
Differences in RGD-tracer uptake between HPV positive and negative tumours
Description
standardized uptake values (SUV) of Ga68-RGD
Time Frame
1 month
Title
Differences in RGD-tracer uptake between the pre- and per-treatment scan
Description
standardized uptake values (SUV) of Ga68-RGD
Time Frame
1 month
Title
Differences in CT perfusion flow parameters between HPV positive and negative tumours
Description
Determining the blood flow using ROIs of the tumour drawn on the contrast enhanced CT
Time Frame
1 month
Title
Differences in CT perfusion parameters between HPV positive and negative tumours
Description
Determining the blood volume using ROIs of the tumour drawn on the contrast enhanced CT
Time Frame
1 month
Title
Differences in CT perfusion flow parameters between the pre- and per-treatment scan
Description
Determining the blood flow using ROIs of the tumour drawn on the contrast enhanced CT
Time Frame
1 month
Title
Differences in CT perfusion parameters between the pre- and per-treatment scan
Description
Determining the blood volume using ROIs of the tumour drawn on the contrast enhanced CT
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Differences in RGD-tracer uptake between patients with locoregional control or recurrence within one year
Description
standardized uptake values (SUV) of Ga68-RGD
Time Frame
1 year
Title
Differences in CT perfusion flow parameters between patients with locoregional control or recurrence within one year
Description
Determining the blood flow using ROIs of the tumour drawn on the contrast enhanced CT
Time Frame
1 year
Title
Differences in CT perfusion parameters between patients with locoregional control or recurrence within one year
Description
Determining the blood volume using ROIs of the tumour drawn on the contrast enhanced CT
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
E Aarntzen, MD, PhD
Phone
+31243614048
Email
Erik.Aarntzen@radboudumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
D Lobeek
Phone
+31243614048
Email
Erik.Aarntzen@radboudumc.nl
Facility Information:
Facility Name
Radboudumc
City
Nijmegen
State/Province
Gelderland
Country
Netherlands
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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