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 thyroid carcinoma |
Het IMP zal worden gebruikt voor de identificatie van schildwachtklieren bij patiënten met schildkliercarcinoom
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E.1.1.1 | Medical condition in easily understood language |
The IMP will be used to identify lymph nodes which are most likely to contain metastasis in patients with thyroid carcinoma |
Het IMP zal worden gebruikt om de lymfeklieren te identificeren die de grootste kans op hebben om metastasen te bevatten bij patiënten met schildkliercarcinoom |
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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 | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10066474 |
E.1.2 | Term | Thyroid 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 | 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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10073554 |
E.1.2 | Term | Sentinel node biopsy |
E.1.2 | System Organ Class | 100000004848 |
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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 |
The primary objective of this study is to prove the concept of sentinel lymph node imaging in thyroid carcinoma using preoperative 68Ga-tilmanocept PET/CT combined with intraoperative gamma probe and fluorescence camera localization. The number of visualized and resected SLNs will be assessed. |
Het primaire doel van deze studie is het concept van schildwachtklier identificatie bij schildkliercarcinoom te bewijzen met behulp van preoperatieve 68Ga-tilmanocept PET/CT gecombineerd met peroperatieve gamma probe en fluorescentie camera. Het aantal gevisualiseerde en gereseceerde schildwachtklieren zal worden geëvalueerd. |
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E.2.2 | Secondary objectives of the trial |
To • Assess the localization of the sentinel lymph nodes • Compare the pathological results of the sentinel lymp nodeswith the results of the rest of the lymph node level • Define the optimal scan protocol • Assess the (additional) surgical time • Quantify how the surgeon experiences the complexity, feasibility and additional value of the various methods to identify the sentinel lymph nodesusing a questionnaire
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Om - De lokalisatie van de schildwachtklieren te bepalen - De pathologie uitslag van de schildwachtklieren te vergelijken met de resultaten van de rest van het lymfeklierniveau - Het optimale scan protocol te bepalen - De (extra) operatietijd vast te stellen - Kwantificeren hoe de chirurg de complexiteit, haalbaarheid en toegevoegde waarde van de verschillende methoden om de schildwachtklieren te identificeren ervaart aan de hand van een vragenlijst
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All of the following criteria: • The patient has provided written informed consent authorization before participating in the study • Cytologic diagnosis of differentiated thyroid carcinoma (Bethesda 6) and will undergo a hemi- or total thyroidectomy, or cytologic diagnosis of medullary thyroid carcinoma(Bethesda 6) • The patient is ≥18 years of age at time of consent • The patient has an ECOG status of Grade 0 – 2 |
Alle volgende criteria: - De patiënt heeft schriftelijke informed consent gegeven voor deelname aan de studie - Cytologische diagnose van gedifferentieerd schildkliercarcinoom(Bethesda 6) en zal een hemi- of totale thyreoïdectomie ondergaan, of cytologische diagnose van medullair schildkliercarcinomo (Bethesda 6) - De patiënt is ≥18 jaar oud op het moment van toestemming - De patiënt heeft ECOG-status graad 0 - 2 |
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E.4 | Principal exclusion criteria |
Any of the following criteria: • The patient is incapacitated • The patient is pregnant or lactating • The patient has a history of neck dissection, gross injury or radiotherapy to the neck that would preclude reasonable surgical dissection for this trial • The patient will undergo minimally invasive thyroid surgery (via the axilla or trans-oral approach) • The patient is actively receiving systemic cytotoxic chemotherapy. • The patient is on immunosuppressive, anti-monocyte, or immunomodulatory therapy • The patient has a preoperatively histologically proven multifocal tumor
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Een van de volgende criteria: - De patiënt is onbekwaam - De patiënt is zwanger of geeft borstvoeding - De patiënt heeft een voorgeschiedenis van halsklierdissectie, ernstig letsel of radiotherapie van de hals die een chirurgische dissectie voor deze studie zou uitsluiten - De patiënt ondergaat minimaal invasieve schildklierchirurgie (via transaxillaire of transorale benadering) - De patiënt krijgt systemische cytotoxische chemotherapie - De patiënt ondergaat een immunosuppressiva, anti-monocyten of immunomodulerende therapie - De patiënt heeft een preoperatief histologisch bewezen multifocale tumor |
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E.5 End points |
E.5.1 | Primary end point(s) |
• Number of sentinel lymph nodes determined on PET/CT • Number of resected sentinel lymph nodes
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- Aantal schildwachtklieren bepaald op PET/CT - Aantal gereseceerde schildwachtklieren
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Within 2 days |
Binnen 2 dagen |
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E.5.2 | Secondary end point(s) |
• Localization of sentinel lymph nodes • Pathology result of sentinel lymph nodes compared to pathology result of rest of lymph node level • Optimal scan protocol • (Additional) surgical time • Questionnaire directed to the surgeon about complexity, feasibility and additional value of various identification methods for sentinel lymph nodes
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- Lokalisatie van schildwachtklieren - Pathologie uitslag van schildwachtklieren in vergelijking met pathologe uitslag van rest van lymfeklierlevel - Optimaal scanprotocol - (Extra) operatietijd - Vragenlijst gericht aan de chirurg over complexiteit, haalbaarheid en toegevoegde waarde van verschillende identificatiemethoden voor schildwachtklieren
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Approximately 1-10 days |
Ongeveer 1-10 dagen |
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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 | Yes |
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 |
Eenarmige studie |
Single arm trial |
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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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After all endpoints are known of all participants, so approximately 10 days after the last inclusion. |
Nadat alle eindpunten bij alle deelnemers bepaald zijn, dus ongeveer 10 dagen na de laatste inclusie. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |