E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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 |
|
E.1.1.1 | Medical condition in easily understood language |
To assess differences between tumours of the head and neck area that might be related to human papillomavirus with the help of minimally invasive molecular imaging. |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10031117 |
E.1.2 | Term | Oropharyngeal squamous cell carcinoma stage III |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10031112 |
E.1.2 | Term | Oropharyngeal squamous cell carcinoma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10031116 |
E.1.2 | Term | Oropharyngeal squamous cell carcinoma stage II |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10031115 |
E.1.2 | Term | Oropharyngeal squamous cell carcinoma stage I |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
|
|
E.2.2 | Secondary objectives of the trial |
To exploratory assess the correlation between the [68Ga]Ga-RGD2 PET/CT and CT perfusion scans and locoregional control at one year follow-up. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
|
|
E.4 | Principal 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
|
|
E.5 End points |
E.5.1 | 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.
|
|
E.5.1.1 | 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. |
|
E.5.2 | 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. |
|
E.5.2.1 | 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. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
The scope of this study is to determine differences in tumour microenvironment between HPV positive and negative oropharyngeal tumours. |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Patients are assigned to a group based on the outcome of the p16 immunohistochemistry of the tumour. |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The trial ends when the (standard of care) 1 year follow up visit is completed by the last subject |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |