E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Imaging of tumours and their metastasis after intravenous injection of
Indocyanine Green to patients with peritoneal carcinomatosis from colorectal cancer. |
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E.1.1.1 | Medical condition in easily understood language |
Imaging of tumours and their metastasis after intravenous injection of
Indocyanine Green to patients with peritoneal carcinomatosis from colorectal cancer. |
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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 |
- Confirmation of the ability of NIR imaging using ICG to demonstrate tumors and peritoneal metastatic implants in patients operated for peritoneal carcinomatosis from colorectal origin.
- Confirmation that mucinous lesions observed in 2 patients recruited in the last study (EudraCT 2013-000653-42) are not visualized fluorescent after IV injection of ICG.
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E.2.2 | Secondary objectives of the trial |
- Evaluation of the ability of NIR imaging using ICG to help the surgeon in scoring the peritoneal carcinomatosis before the beginning of the surgery, aiming to detect more undetectable lesions than under white light.
- Evaluation of the fluorescence intensity observed in the normal tissues after IV injection of ICG depending on the timing between the injection and the excision of the tissue.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients (either newly diagnosed, or relapsing) with peritoneal carcinomatosis from colorectal carcinoma who are candidate for “open” surgery.
- Informed consent form signed.
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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) |
- Confirmation of the ability of NIR imaging using ICG to demonstrate tumors and peritoneal metastatic implants in patients operated for peritoneal carcinomatosis from colorectal origin.
- Confirmation that mucinous lesions observed in 2 patients recruited in the last study (EudraCT 2013-000653-42) are not visualized fluorescent after IV injection of ICG.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After surgery and pathological analysis of the patient |
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E.5.2 | Secondary end point(s) |
- Evaluation of the ability of NIR imaging using ICG to help the surgeon in scoring the peritoneal carcinomatosis before the beginning of the surgery, aiming to detect more undetectable lesions than under white light.
- Evaluation of the fluorescence intensity observed in the normal tissues after IV injection of ICG depending on the timing between the injection and the excision of the tissue.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After surgery and pathological analysis of the patient |
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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
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After surgery and pathological analysis of the last patient |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |