E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with histological or cytological confirmed squamous cell carcinomas of the oral cavity, oropharynx, hypopharynx, larynx, T2-T3-T4, any N, M0 |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067821 |
E.1.2 | Term | Head and neck cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Determine if tumor hypoxia can be accurately visualised with [18F]HX4 PET imaging in head and neck cancer tumors |
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E.2.2 | Secondary objectives of the trial |
- Observe spatial and temporal stability of [18F] HX4 PET images
- Correlation of [18F] HX4 with local tumor recurrence and survival
- Image quality of [18F] HX4-PET at different time points
- Kinetic analysis of HX4
- Correlation of hypoxia imaging with blood hypoxia markers (osteopontin, circulating CA-IX)
- Correlation of hypoxia imaging with tumor tissue biomarkers (HPV, CA-IX, VEGF, EGFR, CD44, HIF-1a, mir-210) and autophagy related genes
- Spatial correlation of [18F] HX4-PET with [18F] FDG PET pre-treatment
- Spatial correlation of [18F] HX4-PET with [18F] FDG PET three months after treatment
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Histological or cytological confirmed HNSSC of the oral cavity, oropharynx, hypopharynx, larynx, T2-T3-T4, any N, M0
- Tumor (or lymph node) diameter ≥ 2,5 cm
- WHO performance status 0 to 2
- Scheduled for primary curative (concurrent chemo-) radiotherapy
- No previous surgery to the head and neck
- No previous radiation to the head and neck
- Adequate renal function (calculated creatinine clearance at least 60 ml/min)
- The patient is willing and capable to comply with study procedures
- 18 years or older
- Have given written informed consent before patien registration
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E.4 | Principal exclusion criteria |
No recent (< 3 months) myocardial infarction
- No Uncontrolled infectious disease
- Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study
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E.5 End points |
E.5.1 | Primary end point(s) |
Tumor to background ratio of [18F]HX4 PET images |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Overlap fraction of (for example) >50% max regions (i) before and during treatment (ii) in the time series.
- Define the optimal time point for HX4 imaging in head and neck cancer, based on the highest tumor to background ratio.
- Determine if there is a relationship between the SUVmax, SUVmean or tumor to muscle ratio in comparison to the amount of osteopontin in the blood, circulating CA-IX in the blood or the degree and presence of tumor tissue markers.
- Overlap fraction of (for example) >50% max regions between HX4-PET and FDG-PET pre-treatment or three months after treatment.
- Correlation of the SUVmax, SUVmean and tumor to muscle ratio in the [18F] HX4 PET images in comparison to local tumor recurrence and survival.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
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 | No |
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 | No |
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 | No |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |