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

Fundacion Clinic per a la Recerca Biomédica62 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Ovarian Epithelial Cancer

Interventions

99mTC nanocolloid albumin injectionDIAGNOSTIC_TEST

All patients will receive an injection of both tracers in order to detect the sentinel lymph node

ICG injectionDIAGNOSTIC_TEST

All patients will receive an injection of both tracers in order to detect the sentinel lymph node

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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). Exclusion Criteria: * 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

Locations (1)

Laura Burunat

Barcelona, Catalonia, Spain

RECRUITING

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.

Time frame: Through study completion (an average of 36 months)

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.

Time frame: 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.

Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by pathology results

Time frame: 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

Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by FIGO stage

Time frame: 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.

Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by biochemistry results

Time frame: Through study completion (an average of 36 months)

Central Contacts

Laura Burunat, Graduate

CONTACT

0034 932275400 burunat@recerca.clinic.cat

Data from ClinicalTrials.gov

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Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to surgical approach

Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by surgical approach

Time frame: Through study completion (an average of 36 months)

Evaluation of anatomical distribution of 99mTC draining

Detection rate of sentinel lymph node with 99mTC in the group of patients having received the tracer

Time frame: 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.

Detection rate and false negative rate of intraoperative detector gamma probe,stratified by morphologic characteristics.

Time frame: 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.

Detection rate and false negative rate of intraoperative detector gamma probe,stratified by pathology results.

Time frame: 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.

Detection rate and false negative rate of intraoperative detector gamma probe,stratified by FIGO stage.

Time frame: 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.

Detection rate and false negative rate of intraoperative detector gamma probe,stratified by biochemistry results.

Time frame: 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.

Detection rate and false negative rate of intraoperative detector gamma probe,stratified by surgical approach.

Time frame: 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

Detection rate and false negative rate of intraoperative NIR camera,stratified by morphological characteristics

Time frame: Through study completion (an average of 36 months)

Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to pathology results.

Detection rate and false negative rate of intraoperative NIR camera,stratified by pathology results.

Time frame: Through study completion (an average of 36 months)

Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to FIGO stage.

Detection rate and false negative rate of intraoperative NIR camera,stratified by FIGO stage.

Time frame: Through study completion (an average of 36 months)

Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to biochemistry results.

Detection rate and false negative rate of intraoperative NIR camera,stratified by biochemistry results.

Time frame: Through study completion (an average of 36 months)

Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to surgical approach.

Detection rate and false negative rate of intraoperative NIR camera,stratified by surgical approach.

Time frame: Through study completion (an average of 36 months)

Anatomical distribution of sentinel lymph node detected with ICG.

Anatomical location of sentinel lymph node according to ICG.

Time frame: Through study completion (an average of 36 months)

Anatomical distribution of sentinel lymph node detected with 99mTC albumin nanocolloid.

Anatomical location of sentinel lymph node according to 99mTC albumin nanocolloid.

Time frame: Through study completion (an average of 36 months)

Comparison of lymph node detection with both tracers.

Assessment of concordance of sentinel lymph node anatomical location detected with each tracer.

Time frame: Through study completion (an average of 36 months)

Evaluation of ultra-staging in micrometastases detection compared to conventional histology.

Pathology ultra-staging evaluation. The following classification will be considered according to the criteria of the American Joint Committee on Cancer (AJCC): * Macrometastases: tumor infiltration \> 2 mm in maximum diameter. * Micrometastases: tumor infiltration between 0.2 and 2 mm in maximum diameter. * Isolated tumor cells or isolated cell group (CTA, GCA): clusters of cells smaller than 0.2 mm

Time frame: Through study completion (an average of 36 months)

Evaluation of the complications associated with each technique.

Chirurgic and post-operative complications, directly or indirectly associated to the use of the tracers.

Time frame: Through study completion (an average of 36 months)