E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
A feasibility study of indocyanine green (ICG) fluorescence mapping for sentinel lymph node detection in early breast cancer |
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E.1.1.1 | Medical condition in easily understood language |
Investigation on Sentinel Lymph node with a fluorescent agent in comparisson with radiocolloid with the aim to do it in the future with fluorescent agent allone |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
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 |
Determine sensitivity of ICG in sentinel lymph node identification if combined with blue dye and radiocolloid |
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E.2.2 | Secondary objectives of the trial |
in how many cases ICG could replace radiocolloid |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- biopsy proven invasive breast cancer in women of any age over 18 years of age
- tumours measuring < 5cm in maximum diameter radiologically (mammography, ultrasound or MRI)
- no evidence of pathological axillary lymph nodes clinically or on ultrasound scan.
- SLNB recommended as part of their surgical management for breast cancer
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E.4 | Principal exclusion criteria |
women unable to provide informed consent
- history of previous breast cancer
- prior axillary surgery or breast excision biopsy
- prior axillary surgery or a diagnostic excision biopsy of the breast
- pregnant or lactating women
- hypersensitivity to indocyanine green (ICG) or to sodium iodide
- hypersensitivity to iodine
- patients with hyperthyroidism or toxic thyroid adenomas
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E.5 End points |
E.5.1 | Primary end point(s) |
Sensitivity of ICG fluorescence, defined as the number of sentinel nodes detected by conventional methods (blue dye, radio-isotope or combination) that are also fluorescent with ICG. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Patients will have a wound inspection, and recording of any adverse events, at their first routine post-operative visit two weeks after surgery. There will be no additional visits required as part of this study after this visit |
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E.5.2 | Secondary end point(s) |
in how many cases radiocolloid could be replaces by ICG |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Patients will have a wound inspection, and recording of any adverse events, at their first routine post-operative visit two weeks after surgery. There will be no additional visits required as part of this study after this visit |
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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 | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
Radiocooloid Tecnetium |
Blue dye |
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E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |