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

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

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

Conditions
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Ovarian Epithelial Cancer

Intervention / Treatment
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* Diagnostic Test: 99mTC nanocolloid albumin injection
* Diagnostic Test: ICG injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional arm<br>All patients will receive an injection of ICG and an injection of 99mTc nanocolloid albumin | Diagnostic Test: 99mTC nanocolloid albumin injection<br>* All patients will receive an injection of both tracers in order to detect the sentinel lymph node<br>Diagnostic Test: ICG injection<br>* All patients will receive an injection of both tracers in order to detect the sentinel lymph node<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Through study completion (an average of 36 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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 | 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 | Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by surgical approach | 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 | 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. | 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. | 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. | 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. | 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. | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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. | Through study completion (an average of 36 months) |