E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Imaging of lymph nodes to be resected in head
and neck cancers |
|
E.1.1.1 | Medical condition in easily understood language |
Technique to better visualize lymph nodes from the cervical region near the tumour |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
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 |
Evaluation of our ability to define per-operatively using NIR camera device the distribution of peritumoraly injected free ICG in the normal and pathological lymph nodes draining the dissected tumor in head and neck cancer patients. |
|
E.2.2 | Secondary objectives of the trial |
- Analysis of the correlation between ICG fluorescence and tumoral invasion in the dissected lymph nodes
- Evaluation of the impact of NIR fluorescence on lymph nodes yield during neck dissection.
- Evaluation of the impact of NIR fluorescence on lymph nodes yield during analysis of the piece in the service of pathology
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- All patients requiring neck dissection with resection of the primary (the decision and the type of neck dissection are preliminary decided during head and neck multidisciplinary oncologic consultation).
- Informed consent form signed.
|
|
E.4 | Principal exclusion criteria |
- Age less than18 years old.
- Inability to give informed consent.
- History of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish.
- Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomies of the thyroid gland.
- Documented coronary disease.
- Advanced renal impairment (creatinine > 1,5mg/dl).
- During the 2 weeks before the enrolment, concurrent medication which reduces or increases the extinction of ICG (i.e. anticonvulsants, haloperidol and heparin).
- Pregnancy, breastfeeding
|
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E.5 End points |
E.5.1 | Primary end point(s) |
Evaluation of our ability to define per-operatively using NIR camera device the distribution of peritumoraly injected free ICG in the normal and pathological lymph nodes draining the dissected tumor in head and neck cancer patients. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
after the surgery and the pathlogical diagnosis |
|
E.5.2 | Secondary end point(s) |
- Analysis of the correlation between ICG fluorescence and tumoral invasion in the dissected lymph nodes
- Evaluation of the impact of NIR fluorescence on lymph nodes yield during neck dissection.
- Evaluation of the impact of NIR fluorescence on lymph nodes yield during analysis of the piece in the service of pathology
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
after the surgery and the pathlogical diagnosis |
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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 | 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 | 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 | 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
|
after surgery and pathological analysis of the pieces of the last subject
enrolled in the study |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |