E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Early stage ovarian cancer |
Cáncer de ovario en estadio inicial |
|
E.1.1.1 | Medical condition in easily understood language |
Early stage ovarian cancer |
Cáncer de ovario en estadio inicial |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
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 | 10052111 |
E.1.2 | Term | Ovarian surgery |
E.1.2 | System Organ Class | 100000004865 |
|
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 |
To describe the feasibility of performing the Sentinel Node technique (Sentinel Node detection rate) in patients with previous ovarian surgery by injecting the tracer into the stump of the infundibular-pelvic ligament and uterus-ovarian ligament |
Describir la factibilidad de la realización de la técnica de GC (Tasa de detección del GC) en pacientes con cirugía previa de ovario inyectando el trazador en el muñón del ligamento infundíbulo-pélvico y útero-ovárico. |
|
E.2.2 | Secondary objectives of the trial |
Technique performance rate, anatomical location of the sentinel node (s), number of sentinel nodes detected |
Tasa de realización de la técnica, localización anatómica del(los) ganglio(s) centinela(s), número de ganglios centinelas detectados. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
· Informed consent signed prior to performing any procedure related to the clinical trial. · Women over 18 years old at the time of inclusion. · Patients with anatomopathological diagnosis of malignant ovarian tumor in a deferred study, proposals for staging surgery or patients with suspicious of malignant tumor who are going to be subjected to exploratory laparotomy and operative biopsy, and in case of positivity, staging surgery will be performed. |
- Consentimiento informado firmado previamente a la realización de cualquier procedimiento relacionado con el ensayo clínico. - Mujer mayor o igual de 18 años de edad en el momento de la inclusión. - Pacientes con diagnóstico anatomopatológico de tumoración ovárica maligna en estudio diferido propuestas para cirugía de estadiaje o pacientes con tumoración sospechosa de malignidad que van a ser sometidas a laparotomía exploradora y biopsia operatoria, y que en el caso de positividad de la misma se vaya a realizar cirugía de estadiaje. |
|
E.4 | Principal exclusion criteria |
· Non-obtaining / informed consent withdrawal. · Benign result in extemporaneous study. · Previous history of vascular surgery in the aorta, cava or pelvic vessels. · Previous pelvic or paraaortic lymphadenectomy. · Previous lymphoma. · Previous abdominopelvic tumor. · Previous allergic reaction to indocyanine green. · Pregnancy / Breastfeeding. |
· No obtención/ revocación del consentimiento informado. · Resultado benigno en estudio extemporáneo. · Historia previa de cirugía vascular en aorta, cava o vasos pélvicos. · Linfadenectomía pélvica o paraaórtica previa. · Linfoma previo. · Tumor abdomino-pélvico previo. · Reacción alérgica previa al verde indocianina. · Gestación/ Lactancia. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Sentinel Node detection rate |
Tasa de detección de GC |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 0 (intraoperative) |
Día 0 (intraoperatorio) |
|
E.5.2 | Secondary end point(s) |
Tumor size, tumor location, injection site, injection-detection interval, number of lymph nodes detected (with Tc99, with, indocyanine green or both), anatomical location of the sentinel, number of detected sentinel nodes, intensity of the radioactive signal of the gamma -camera, surgical procedure performed, histological type, degree of differentiation, binary classification, histological result of the sentinel lymph node and the rest of lymph nodes obtained in lymphadenectomy and FIGO stage |
Tamaño tumoral, localización tumoral, lugar de inyección, intervalo inyección-detección, número de ganglios detectados (con Tc99, con, verde indocianina o ambos), localización anatómica del centinela, número de ganglios centinelas detectados, intensidad de la señal radioactiva de la gamma-cámara, procedimiento quirúrgico realizado,tipo histológico, grado de diferenciación, clasificación binaria, resultado histológico del ganglio centinela y del resto de ganglios obtenidos en la linfadenectomía y estadio FIGO |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 0 and day 30 |
Día 0 y día 30 |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
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) | 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 | 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.8.2.4 | 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
|
|
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 | 18 |
E.8.9.1 | In the Member State concerned days | |