E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
GIST Gastrointestinal stromal cell tumour |
GIST Gastrointestinale stroma tumoren |
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E.1.1.1 | Medical condition in easily understood language |
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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 | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Primary objective: to assess the diagnostic value of ICG in intraoperative GIST and GIST metastasis detection
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. Het primaire eindpunt is de diagnostische waarde van ICG voor intra-operatieve detectie van GIST met NIR camera’s. |
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E.2.2 | Secondary objectives of the trial |
Secondary objective: tumor to background ratio will be determined, which is defined as the fluorescence signal in the tumor compared to the fluorescence signal of the surrounding tissue |
de tumor versus achtergrond ratio van het fluorescerende signaal zal worden bepaald. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients diagnosed with GIST by histology, localized or metastasized, scheduled to undergo an elective open or laparoscopic resection. >18 years
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Patiënten met de diagnose GIST door histologie, gelokaliseerd of gemetastaseerd, gepland voor open of laparoscopische resectie |
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E.4 | Principal exclusion criteria |
History of an allergy or hypersensitivity to sodium iodide, iodine or ICG Patients with hyperthyroidism and patients with an autonomous thyroid adenoma Patients pregnant or breastfeeding Patients with severe renal insufficiency (eGFR <30)
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Bekend met allergie, hypersensiviteit voor sodium jodide, jodide of ICG Patienten met hyperthyroidie and patienten met een autonome thyroide adenoom Zwangere patienten of patienten die bortvoeding geven Patienten met ernstige renale insufficientie (eGFR <30) |
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E.5 End points |
E.5.1 | Primary end point(s) |
percentage of patients in whom during surgery the GIST or metastases can be identified with ICG and NIR. The signal in tumour tissue compared to the signal of the surrounding tissue, i.e. tumour-to-backgroundratio (TBR) will be calculated. Furthermore, number of tumor depositions only visible for the surgeon with NIR imaging will be registered |
Percentage van patienten van wie GIST gedurende de ingreep geidentificeerd kan worden met ICG en NIR. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
During/Directly after surgery |
Gedurende en direct volgend op operatie |
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E.5.2 | Secondary end point(s) |
The signal in tumour tissue compared to the signal of the surrounding tissue, i.e. tumour-to-backgroundratio (TBR) will be calculated. Furthermore, number of tumor depositions only visible for the surgeon with NIR imaging will be registered |
Het tumor signaalwordt vergeleken met het achtergrond signaal waarna de ratio wordt berekend. Ook het aantal tumordeposities wordt geregistreerd. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
During/Directly after surgery |
Gedurende en direct volgend op operatie |
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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) | Yes |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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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After inclusion and operation in 10 patients |
Na inclusie en operatie van 10 patienten |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |