E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Colon carcinoma |
Colon carcinoom |
|
E.1.1.1 | Medical condition in easily understood language |
Large bowel cancer |
Dikke darm kanker |
|
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 |
Assess safety and feasibility of SLN identification using submucosal peritumoral ICG injections. |
Het bepalen van veiligheid en haalbaarheid van SWK identificatie, met behulp van peri-tumorale ICG injectie. |
|
E.2.2 | Secondary objectives of the trial |
- Assessing detection rate of SLN identification - Assessing sensitivity of SLN identification - Assessing the incidence of micrometastases after ultrastaging - Assessing adverse reactions towards ICG |
- Bepalen van de detectie ratio van de SWK identificatie - Bepalen van de sensitiviteit van de SWK identificatie - Bepalen van de incidentie van micrometastase - Bijwerkingen tegen ICG |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Oral and written informed consent (IC) - Aged 18 years and older - Pathologically confirmed and/or suspected colon carcinoma |
- Mondelinge en schriftelijke informed consent (IC) - 18 jaar en ouder - Pathologisch bevestigd en/of verdenking op colon carcinoom |
|
E.4 | Principal exclusion criteria |
- Distant metastases - Suspicion of T3-T4 disease based on pre-operative assessment. - Metastatic or T4 disease discovered during intraoperative staging - A tumour too large to pass endoscopically - Pregnant patients - Known allergy to any of the compound used for SLN identification (ICG, Iodine) - Suspected or proven lymph node metastasis - Previous colon surgery - Contra-indication for robotic surgery - Ink marking close to the tumour |
- Metastasen op afstand - Verdenking op T3-T4 tumor op basis van de pre-operatieve work-up - Metasten of T4 ontdekt tijdens de operatie - Een tumor die te groot is om endoscopisch te passeren - Zwangere patienten - Een bekende allergie voor een van de bestandsdelen die gebruikt wordt voor schildwachtklier identificatie (ICG, iodium) - Verdenking op of bevestigde lymfeklier metastasen - Eerdere colon chirurgie - Een inkt markering dichtbij de tumor |
|
E.5 End points |
E.5.1 | Primary end point(s) |
- Identification rate of SLN with ICG - Number of adverse or allergic reactions towards ICG
|
- Identificatie ratio van SWK met ICG - Aantal bijwerkingen of allergische reacties tegen ICG |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Identification ration will be assesed intra-operatively Number of adverse/allergic events will be assessed intra and post-operatively |
Identificatie ratio wordt intra-operatief bepaald Aantal bijwerkingen/allergische reacties worden intra- en post operatief bepaald. |
|
E.5.2 | Secondary end point(s) |
- False negative SLN rate - Sensitivity of SLN - Number of patients who are upstaged by ultrastaging techniques - Number and status of aberrant lymph nodes - Accuracy: conformity of the SLN status and the regional node status
|
- Vals negatieve SWK ratio - Sensitiviteit van de SWK - Aantal patienten die 'geupstaged' zijn dmv ultrastaging - Aantal aberrante lymfeklieren en de status van deze lymphe klieren - Nauwkeurigheid; dwz overlap tussen SWK en regionale klier status. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
All secondary endpoints will be collected postoperatively, after pathological assessment is completed. |
Alle secundaire eindpunten worden postoperatief gedaan, nadat de pathologie is uitgevoerd. |
|
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 | Yes |
E.8.1.7.1 | Other trial design description |
Open cohort, veiligheid haalbaarheid |
Open cohort, safety and feasibility |
|
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.8.2.4 | 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
|
End of the trial is after pathological assessment of all 10 patients. |
Het einde van de trial is indien pathologische analyse is gedaan bij alle 10 patienten. |
|
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 | |