Oropharyngeal Squamous Cell CarcinomaPhase 2PIVOTNCT04222543
Imaging of Tumour Microenvironment in Patients With Oropharyngeal Head and Neck Squamous Cell Carcinoma Using RGD PET/CT Imaging
A Phase 2 study testing RGD PET/CT in people with Oropharyngeal Squamous Cell Carcinoma, run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Squamous Cell Carcinoma
- What is being tested?
- RGD PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Nov 2019to 1 Sep 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Contra-indications for PET
- Contra-indications for administration of iodine-containing contrast agents
- Other serious illness that can affect the scans
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Oropharyngeal Squamous Cell Carcinoma
- Being tested
- RGD PET/CT
- Keywords
- Tumour microenvironment, Chemoradiotherapy, Oropharyngeal squamous cell carcinoma, Human papilloma virus, Positron emission tomography
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RGD PET/CTCombination product
Also called CT perfusion
Patients will receive an RGD PET/CT and a CT perfusion scan prior to treatment and during chemoradiotherapy
| Study group | Role | What they receive |
|---|---|---|
| HPV Negative tumours | Active comparator | Patients will receive four scans. Receives: Combination Product: RGD PET/CT |
| HPV positive tumours | Active comparator | Patients will receive four scans. Receives: Combination Product: RGD PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in RGD-tracer uptake between HPV positive and negative tumours
standardized uptake values (SUV) of Ga68-RGD
Measured: 1 month
Differences in RGD-tracer uptake between the pre- and per-treatment scan
standardized uptake values (SUV) of Ga68-RGD
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 month
Secondary outcomes (3)
Differences in RGD-tracer uptake between patients with locoregional control or recurrence within one year
standardized uptake values (SUV) of Ga68-RGD
Measured: 1 year
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
Measured: 1 year
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start22 Nov 2019
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Imaging results of HPV positive tumours are compared to imaging results of HPV negative tumours.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222543
- Sponsor's protocol ID
- NL69928.091.19
- Acronym
- PIVOT
- Status last verified
- Nov 2019
- First submitted
- 20 Nov 2019
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging of Tumour Microenvironment in Patients With Oropharyngeal Head and Neck Squamous Cell Carcinoma Using RGD PET/CT Imaging
- ClinicalTrials.gov ID
- NCT04222543
- Acronym / sponsor ID
- PIVOT / NL69928.091.19
- Conditions
- Oropharyngeal Squamous Cell Carcinoma
- Keywords
- Tumour microenvironment, Chemoradiotherapy, Oropharyngeal squamous cell carcinoma, Human papilloma virus, Positron emission tomography
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 10 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Imaging results of HPV positive tumours are compared to imaging results of HPV negative tumours.
| Arm | Type | Receives |
|---|---|---|
| HPV Negative tumours | Active comparator | Combination Product: RGD PET/CTPatients will receive four scans. |
| HPV positive tumours | Active comparator | Combination Product: RGD PET/CTPatients will receive four scans. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Contra-indications for PET
- Contra-indications for administration of iodine-containing contrast agents
- Other serious illness that can affect the scans
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RGD PET/CTAlso: CT perfusionPatients will receive an RGD PET/CT and a CT perfusion scan prior to treatment and during chemoradiotherapy | Combination product | HPV Negative tumours, HPV positive tumours |
Primary outcome
Differences in RGD-tracer uptake between HPV positive and negative tumours
Time frame: 1 month
standardized uptake values (SUV) of Ga68-RGD
Differences in RGD-tracer uptake between the pre- and per-treatment scan
Time frame: 1 month
standardized uptake values (SUV) of Ga68-RGD
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
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
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
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
3 secondary outcomes
Differences in RGD-tracer uptake between patients with locoregional control or recurrence within one year
Time frame: 1 year
Differences in CT perfusion flow parameters between patients with locoregional control or recurrence within one year
Time frame: 1 year
Differences in CT perfusion parameters between patients with locoregional control or recurrence within one year
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RGD PET/CT in people with Oropharyngeal Squamous Cell Carcinoma, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact E Aarntzen, MD, PhD (+31243614048, Erik.Aarntzen@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in RGD-tracer uptake between HPV positive and negative tumours (time frame: 1 month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2020.