About this trial
Study to evaluate the diagnostic precision of ICG and 99mTc nanocolloid albumin in sentinel lymph node detection in early ovarian epithelial cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Patients <18 years
Pregnancy or breastfeeding
Epithelial ovarian tumors stage FIGO III or IV.
Impossibility to obtain a biopsy from the tumor.
Trial design
Single group
Treatments tested in this trial
99mTC nanocolloid albumin injection
Diagnostic testAll patients will receive an injection of both tracers in order to detect the sentinel lymph node
ICG injection
Diagnostic testAll patients will receive an injection of both tracers in order to detect the sentinel lymph node
Treatment groups
Trial outcomes
Primary outcomes
Evaluation of the diagnostic efficiency of both tracers in sentinel lymph node detection
Global detection rate of sentinel lymph node in patients having received both tracers.
Secondary outcomes
Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to morphological characteristics
Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by morphologic characteristics.
Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to pathology results.
Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by pathology results
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
Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by FIGO stage
Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to biochemistry results.
Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by biochemistry results
Sponsors and contacts
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