E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Head and neck cancer for which surgical excision has been determined by the multidisciplinary tumor board |
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E.1.1.1 | Medical condition in easily understood language |
Head and neck cancer for which surgical excision has been determined by the multidisciplinary tumor board |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05] |
MedDRA Classification |
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 |
- To determine the feasibility of combining targeted fluorescence imaging of the excised tissue specimen with fluorescence-guided fresh frozen sectioning of the ex-vivo tissue specimen intra-operatively; - To compare the tumor-positive margin detection rates and false-positive fluorescence results with previous fluorescence studies (ICON phase-II) and standard of care; - To enhance the intra-operative workflow of tissue analysis by both the surgeon and pathologist.
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E.2.2 | Secondary objectives of the trial |
- To obtain information on safety aspects of cetuximab-800CW administration by registration of side effects, adverse events (AE), serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR); - To investigate the potential feasibility of novel 3D microscopic imaging techniques on 3D depth assessment of the obtained biopsies, if available; - To correlate and validate fluorescence signals ex vivo with histopathology.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Cytology and/or histology-confirmed diagnosis of oral squamous cell carcinoma and scheduled to undergo surgical removal as decided by the multidisciplinary head and neck tumor board of the UMCG; - Age ≥ 18 years; - Written informed consent.
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E.4 | Principal exclusion criteria |
- Medical or psychiatric conditions that compromise the patient’s ability to give informed consent; - Concurrent uncontrolled medical conditions; - Received an investigational drug within 30 days prior to the dose of cetuximab-800CW; - History of myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure, significant liver disease (ALT >3X upper limits of normal or increased total bilirubin) or unstable angina within 6 months prior to enrollment; - Inadequately controlled hypertension with or without current antihypertensive medications; - History of allergy or infusion reactions cetuximab or other monoclonal antibody therapies; - Pregnant or lactating women. Documentation of a negative pregnancy test must be available for women of childbearing potential. Moreover, the need to be willing to ensure that she or her partner uses effective contraception during the trial and for 6 months thereafter. Woman of childbearing potential are premenopausal women with intact reproductive organs and women less than two years after menopause; - Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females) - Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. - Life expectancy < 12 weeks;
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E.5 End points |
E.5.1 | Primary end point(s) |
- Macroscopic fluorescent signals on the excised tissue specimen and tracer distribution observed with fluorescence imaging; - Detection rates of tumor-positive margins and close margins using fluorescence imaging and FFS; - Number of additional resections based on the obtained fluorescent imaging and FFS data.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After trial has been finished (inclusion of 20 patients) |
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E.5.2 | Secondary end point(s) |
- Patient characteristics (age, sex, BMI, history and morbidity, localization of primary tumor and lymph node metastasis, vital parameters and presence of symptoms before and after tracer administration); - Feasibility of on-site, intra-operative, tissue analysis by both surgeon and pathologist; - Feasibility of novel 3D imaging methods of the obtained additional biopsies (if clinical feasible) and correlation with standard histopathology, if available.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After trial has been finished (inclusion of 20 patients) |
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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 | Yes |
E.6.4 | Safety | Yes |
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 | 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 | Yes |
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 | 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
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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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |