Sentinel Node Detection With Technetium-99m Albumin Nanocolloid and ICG in Patients With Epithelial Ovarian Cancer

Официальное название

Sentinel Node Detection With Technetium-99m Albumin Nanocolloid and Indocyanine Green (ICG) in Patients With Epithelial Ovarian Cancer in Early Stages: Pilot Study

Обзор

Study to evaluate the diagnostic precision of ICG and 99mTc nanocolloid albumin in sentinel lymph node detection in early ovarian epithelial cancer.

Вмешательства

• Диагностический тест 99mTC nanocolloid albumin injection
  All patients will receive an injection of both tracers in order to detect the sentinel lymph node
• Диагностический тест ICG injection
  All patients will receive an injection of both tracers in order to detect the sentinel lymph node

Первичные конечные точки

• Evaluation of the diagnostic efficiency of both tracers in sentinel lymph node detection [Срок оценки: Through study completion (an average of 36 months)]

Вторичные конечные точки (12)

• Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to morphological characteristics [Срок оценки: Through study completion (an average of 36 months)]
• Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to pathology results. [Срок оценки: Through study completion (an average of 36 months)]
• Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to International Federation of Gynecology and Obstetrics (FIGO) stage [Срок оценки: Through study completion (an average of 36 months)]
• Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to biochemistry results. [Срок оценки: Through study completion (an average of 36 months)]
• Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to surgical approach [Срок оценки: Through study completion (an average of 36 months)]
• Evaluation of anatomical distribution of 99mTC draining [Срок оценки: Through study completion (an average of 36 months)]
• Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to morphological characteristics. [Срок оценки: Through study completion (an average of 36 months)]
• Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to pathology results. [Срок оценки: Through study completion (an average of 36 months)]
• Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to FIGO stage. [Срок оценки: Through study completion (an average of 36 months)]
• Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to biochemistry results. [Срок оценки: Through study completion (an average of 36 months)]
• Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to surgical approach. [Срок оценки: Through study completion (an average of 36 months)]
• Evaluation of the performance of intraoperative Near Infrared (NIR) camera in the display of ovarian lymphatic map according to morphological characteristics [Срок оценки: Through study completion (an average of 36 months)]

Критерии участия

Критерии включения

• Patients with adnexal mass diagnosed with high suspicion of malignancy that will undergo intraoperative biopsy or patients with already diagnosed epithelial cancer in early stages in a previous surgery and confirmed by pathology with complete staging indicated.
• Absence of retroperitoneal ganglionary affectation and metastatic disease evaluated by preoperative imaging techniques.
• Signing of informed consent by the patient or relative in charge.
• Women with childbearing potential must compromise to use highly effective contraceptive methods (partner vasectomized, sexual abstinence) until the end of the study (last study visit).

Критерии исключения

• Patients <18 years
• Pregnancy or breastfeeding
• Epithelial ovarian tumors stage FIGO III or IV.
• Impossibility to obtain a biopsy from the tumor.
• History of previous vascular surgery (cava vein, aorta, iliac blood vessels) or radiotherapy in pelvic or para-aortic area.
• Sentinel lymph node biopsy will not be performed if intraoperative histologic study shows a benign ovarian tumor, low malignancy potential tumor or expansive mucinous histology.
• Patient not able to undergo surgery.
• Hypersensitivity to active principle, to sodium iodide or iodine allergy.
• Patients with clinic hyperthyroidism, thyroid autonomous adenomas or focal and diffused autonomous alteration of thyroid gland

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Испания · 1 центр

• Laura Burunat — Barcelona

Идентификаторы

NCT: NCT05937620 · 2023-505667-37-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗