NCT04222543

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2019

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

November 22, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 10, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

January 10, 2020

Status Verified

November 1, 2019

Enrollment Period

2.8 years

First QC Date

November 20, 2019

Last Update Submit

January 6, 2020

Conditions

Oropharyngeal Squamous Cell Carcinoma

Keywords

Tumour microenvironmentChemoradiotherapyOropharyngeal squamous cell carcinomaHuman papilloma virusPositron emission tomography

Outcome Measures

Primary Outcomes (6)

  • Differences in RGD-tracer uptake between HPV positive and negative tumours

    standardized uptake values (SUV) of Ga68-RGD

    1 month

  • Differences in RGD-tracer uptake between the pre- and per-treatment scan

    standardized uptake values (SUV) of Ga68-RGD

    1 month

  • 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

  • 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

  • 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

  • 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 Outcomes (3)

  • Differences in RGD-tracer uptake between patients with locoregional control or recurrence within one year

    1 year

  • Differences in CT perfusion flow parameters between patients with locoregional control or recurrence within one year

    1 year

  • Differences in CT perfusion parameters between patients with locoregional control or recurrence within one year

    1 year

Study Arms (2)

HPV Negative tumours

ACTIVE COMPARATOR

Patients will receive four scans.

Combination Product: RGD PET/CT

HPV positive tumours

ACTIVE COMPARATOR

Patients will receive four scans.

Combination Product: RGD PET/CT

Interventions

RGD PET/CTCOMBINATION_PRODUCT

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

Also known as: CT perfusion
HPV Negative tumoursHPV positive tumours

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, Netherlands

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Cytidine Triphosphate

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Cytosine NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Central Study Contacts

E Aarntzen, MD, PhD

CONTACT

+31243614048Erik.Aarntzen@radboudumc.nl

D Lobeek

CONTACT

+31243614048Erik.Aarntzen@radboudumc.nl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Imaging results of HPV positive tumours are compared to imaging results of HPV negative tumours.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2019

First Posted

January 10, 2020

Study Start

November 22, 2019

Primary Completion

September 1, 2022

Study Completion

September 1, 2023

Last Updated

January 10, 2020

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)