E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The IMP will be used for the identification of sentinel lymph nodes in patients with high/high-intermediate risk endometrial cancer. |
Het IMP zal gebruikt worden voor de identificatie van schildwachtklieren in patiënten met hoog/hoog-intermediate risico endometriumcarcinoom. |
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E.1.1.1 | Medical condition in easily understood language |
The IMP will be used for the identification of sentinel lymph nodes in patients with endometrial cancer. |
Het IMP zal gebruikt worden voor het opsporen van schildwachtklieren in patiënten met baarmoederkanker. |
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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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10014733 |
E.1.2 | Term | Endometrial cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10014738 |
E.1.2 | Term | Endometrial cancer stage I |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10014739 |
E.1.2 | Term | Endometrial cancer stage II |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10072873 |
E.1.2 | Term | Sentinel lymph node mapping |
E.1.2 | System Organ Class | 100000004848 |
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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 |
The primary objective of this pilot study is to evaluate feasibility of 68Ga-tilmanocept PET/CT for sentinel lymph node (SLN) mapping in patients with stage I-II high/high-intermediate risk endometrial cancer. The SLN detection rate with 68Ga-tilmanocept PET will be assessed. |
Het primaire doel van deze studie is om de toepasbaarheid van 68Ga-tilmanocept PET/CT voor de identificatie van schildwachtklieren te evalueren in patienten met stadium I-II hoog/hoog-intermediate risico endometriumcarcinoom. |
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E.2.2 | Secondary objectives of the trial |
- To investigate the correlation between SLN detection rate and anatomical location of SLNs with preoperative 68Ga-tilmanocept PET versus intraoperative ICG with NIR fluorescence; - To assess pathological status of the SLNs: tumour negative, macrometastasis (diameter >2.0 mm), micrometastasis (diameter between 0.2 and 2.0 mm) or isolated tumour cells (diameter <0.2 mm or individual tumour cells)). - To investigate adverse events related to SLN mapping with 68Ga-tilmanocept PET/CT (graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0)(18).
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- Locatie van de schildwachtklieren op PET/CT en intraoperatief met ICG beoordelen en aan elkaar correleren; - Histopathologische uitslag van de schildwachtklieren beoordelen (aan- of afwezigheid van geïsoleerde tumorcellen en (micro-)metastasen); - Bestuderen van complicaties gerelateerd aan de schildwachtklierprocedure met 68Ga-tilmanocept PET/CT (volgens de CTCAE v5.0). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Clinical FIGO 2012 stage I-II high/high-intermediate risk endometrial cancer; - Scheduled for robot-assisted full pelvic and para-aortic staging; - Age ≥18 years and able to provide informed consent.
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- Klinisch stadium I-II hoog/hoog-intermediate risico endometriumcarcinoom; - Gepland voor robot-geassisteerde stadiering van de pelviene en para-aortale lymfeklieren; - Leeftijd ≥18 jaar en bekwaam om informed consent te geven. |
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E.4 | Principal exclusion criteria |
- Pregnancy or current breastfeeding; - Prior severe allergic reaction to iodine; - Severe renal insufficiency (stage 3 or 4); - Clinical or radiological evidence of metastatic disease.
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- Zwangerschap of geven van borstvoeding; - Bekend met eerdere ernstige allergische reactie op jodium; - Ernstige nierinsufficiëntie (stadium 3 of 4); - Klinisch of radiologische verdenking op metastasen. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint is the feasibility of the SLN procedure using 68Ga-tilmanocept in adjunct to ICG with NIR fluorescence in patients with high/high-intermediate risk endometrial cancer. The feasibility is assessed by the SLN detection rate of 68Ga-tilmanocept PET/CT. |
Het primaire eindpunt is de toepasbaarheid van 68Ga-tilmanocept PET/CT voor de identificatie van schildwachtklieren te evalueren in patienten met stadium I-II hoog/hoog-intermediate risico endometriumcarcinoom. Toepasbaarheid wordt beoordeeld aan de hand van de schildwachtklier detectiegraad met PET/CT. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
This primary end point is evaluated at the end of this pilot study containing 10 patients. Data on the primary end point will be collected preoperatively and intraoperatively. |
Het primaire eindpunt wordt beoordeeld aan het einde van deze pilot studie van 10 patiënten. |
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E.5.2 | Secondary end point(s) |
- Correlation between SLN detection rate and anatomical location of SLNs with preoperative 68Ga-tilmanocept PET versus intraoperative ICG with NIR fluorescence; - Pathological status of the SLNs: negative, macrometastasis (diameter >2.0 mm), micrometastasis (diameter between 0.2 and 2.0 mm) or isolated tumour cells (diameter <0.2 mm or individual tumour cells)); - Adverse events related to SLN mapping with 68Ga-tilmanocept PET/CT (graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0).
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- Locatie van de schildwachtklieren op PET/CT en intraoperatief met ICG; - Histopathologische uitslag van de schildwachtklieren (aan- of afwezigheid van geïsoleerde tumorcellen en (micro-)metastasen); - Complicaties gerelateerd aan de schildwachtklierprocedure met 68Ga-tilmanocept PET/CT (volgens de CTCAE v5.0). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
This secondary end points are evaluated at the end of this pilot study containing 10 patients. Data on the secondary end points will be collected preoperatively, intraoperatively and postoperatively (e.g. pathological status). |
De secundaire eindpunten wordt beoordeeld aan het einde van deze pilot studie van 10 patiënten. |
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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 | Yes |
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 | No |
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 |
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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
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The study ends when all end points are collected of the last subject, approximately 10 days after the last study procedure (being SLN procedure). |
De studie is afgerond wanneer alle eindpunten van de laatste studiepatiënt zijn verzameld, ongeveer 10 dagen na de laatste studieprocedure (de schildwachtklierprocedure). |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | |