Imaging of newly formed blood vessels in tumors of the mouth and throat cavity

Imaging of tumour microenvironment in patients with oropharyngeal head and neck squamous cell carcinoma using RGD PET/CT imaging. - PIVOT study

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001843-37-NL

Enrollment

Registered

2019-06-04

Start date

2019-08-06

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The aim of this study is to assess differences in tumour microenvironment between HPV positive and HPV negative oropharyngeal head and neck squamous cell carcinoma using [68Ga]Ga-RGD2 PET/CT and perfusion CT MedDRA version: 20.0 Level: LLT Classification code 10031117 Term: Oropharyngeal squamous cell carcinoma stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and pol

Interventions

Product Name: Ga-68-DOTA-E-(cRGDfK)2 Pharmaceutical Form: Solution for injection INN or Proposed INN: INN not yet been requested to the WHO Other descri

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients with a histologically proven OHNSCC; - P-16 immunohistochemical analysis to determine HPV status of the tumour; - A primary tumour lesion with a diameter of at least 1.0 cm concluded from a diagnostic CT, MRI or FDG PET/CT scan within 4 weeks prior to intake; - Planned chemoradiotherapy as primary treatment; - Age of at least 18 years; - Ability to provide written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: - Contra-indication for (PET/)CT: Pregnancy; Breast-feeding; Severe claustrophobia. - Contra-indication for administration of iodine-containing contrast agents. - Other serious illness, e.g. history of malignancies - Estimated creatinine clearance = 30 mL/min according to the Cockcroft-Gault formula

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to assess the differences in [68Ga]Ga-RGD2 uptake and CT perfusion parameters between HPV+ HNSCC tumours and HPV- HNSCC tumours in patients who will be treated with chemoradiotherapy. Furthermore, the changes in [68Ga]Ga-RGD2 uptake and CT perfusion parameters in tumours before and during chemoradiotherapy will be investigated. ;Secondary Objective: To exploratory assess the correlation between the [68Ga]Ga-RGD2 PET/CT and CT perfusion scans and locoregional control at one year follow-up.; Primary end point(s): - The difference in tumour uptake values of [68Ga]Ga-RGD2 between HPV+ and HPV- tumours. - The difference in tumour perfusion parameters between HPV+ and HPV- tumours. - Changes of [68Ga]Ga-RGD2 uptake before start and in the second week of treatment within all patients. - Changes of perfusion parameters before start and in the second week of treatment within all patients. - Difference in changes of [68Ga]Ga-RGD2 uptake and perfusion parameters before start and in the second week of treatment between the HPV+ and HPV- tumours. ;Timepoint(s) of evaluation of this end point: In total 20 patients will undergo a pre- and per treatment PET/CT scan with [68Ga]Ga-RGD2 and CT perfusion scan. The main study parameters are the differences in tracer uptake and CT perfusion parameters. Therefore, tracer uptake in tumor tissue will be determined quantitatively (Standardized Uptake Values, SUVs). With the SUVs and quantitative CT perfusion parameters, differences in uptake between HPV+ and HPV- are quantified. Aswell as differences in uptake pre- and per-treatment. When 20 patients are included and scanned, differences can be assessed.	—

Measure

Time frame

Main Objective: The primary objective of this study is to assess the differences in [68Ga]Ga-RGD2 uptake and CT perfusion parameters between HPV+ HNSCC tumours and HPV- HNSCC tumours in patients who will be treated with chemoradiotherapy. Furthermore, the changes in [68Ga]Ga-RGD2 uptake and CT perfusion parameters in tumours before and during chemoradiotherapy will be investigated. ;Secondary Objective: To exploratory assess the correlation between the [68Ga]Ga-RGD2 PET/CT and CT perfusion scans and locoregional control at one year follow-up.; Primary end point(s): - The difference in tumour uptake values of [68Ga]Ga-RGD2 between HPV+ and HPV- tumours. - The difference in tumour perfusion parameters between HPV+ and HPV- tumours. - Changes of [68Ga]Ga-RGD2 uptake before start and in the second week of treatment within all patients. - Changes of perfusion parameters before start and in the second week of treatment within all patients. - Difference in changes of [68Ga]Ga-RGD2 uptake and perfusion parameters before start and in the second week of treatment between the HPV+ and HPV- tumours. ;Timepoint(s) of evaluation of this end point: In total 20 patients will undergo a pre- and per treatment PET/CT scan with [68Ga]Ga-RGD2 and CT perfusion scan. The main study parameters are the differences in tracer uptake and CT perfusion parameters. Therefore, tracer uptake in tumor tissue will be determined quantitatively (Standardized Uptake Values, SUVs). With the SUVs and quantitative CT perfusion parameters, differences in uptake between HPV+ and HPV- are quantified. Aswell as differences in uptake pre- and per-treatment. When 20 patients are included and scanned, differences can be assessed.

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Secondary

Measure	Time frame
Secondary end point(s): - Exploratory differences in [68Ga]Ga-RGD2 uptake and perfusion parameters between the patients with locoregional control and patients with locoregional recurrence within one year.;Timepoint(s) of evaluation of this end point: In total 20 patients will undergo a pre- and per treatment PET/CT scan with [68Ga]Ga-RGD2 and CT perfusion scan. Locoregional control determined at the end of treatment and at one year follow up will be used to exploratory assess differences in tracer uptake and CT perfusion parameters between patients with locoregional control and patients with locoregional recurrence within one year. Therfore, the evaluation will take place after all patients had one year of follow up.	—

Measure

Time frame

Secondary end point(s): - Exploratory differences in [68Ga]Ga-RGD2 uptake and perfusion parameters between the patients with locoregional control and patients with locoregional recurrence within one year.;Timepoint(s) of evaluation of this end point: In total 20 patients will undergo a pre- and per treatment PET/CT scan with [68Ga]Ga-RGD2 and CT perfusion scan. Locoregional control determined at the end of treatment and at one year follow up will be used to exploratory assess differences in tracer uptake and CT perfusion parameters between patients with locoregional control and patients with locoregional recurrence within one year. Therfore, the evaluation will take place after all patients had one year of follow up.

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Countries

Netherlands

Contacts

Public ContactDepartment Nuclear Medicine

Radboud University Medical Center

daphne.lobeek@radboudumc.nl+31243666283

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026