Ovarian Epithelial Cancer
Conditions
Brief summary
Study to evaluate the diagnostic precision of ICG and 99mTc nanocolloid albumin in sentinel lymph node detection in early ovarian epithelial cancer.
Interventions
DIAGNOSTIC_TEST99mTC nanocolloid albumin injection
All patients will receive an injection of both tracers in order to detect the sentinel lymph node
DIAGNOSTIC_TESTICG injection
All patients will receive an injection of both tracers in order to detect the sentinel lymph node
Sponsors
Fundacion Clinic per a la Recerca Biomédica
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the diagnostic efficiency of both tracers in sentinel lymph node detection | Through study completion (an average of 36 months) | Global detection rate of sentinel lymph node in patients having received both tracers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to morphological characteristics | Through study completion (an average of 36 months) | 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. | Through study completion (an average of 36 months) | 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 | Through study completion (an average of 36 months) | 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. | Through study completion (an average of 36 months) | Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by biochemistry results |
| Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to surgical approach | Through study completion (an average of 36 months) | Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by surgical approach |
| Evaluation of anatomical distribution of 99mTC draining | Through study completion (an average of 36 months) | Detection rate of sentinel lymph node with 99mTC in the group of patients having received the tracer |
| Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to morphological characteristics. | Through study completion (an average of 36 months) | Detection rate and false negative rate of intraoperative detector gamma probe,stratified by morphologic characteristics. |
| Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to pathology results. | Through study completion (an average of 36 months) | Detection rate and false negative rate of intraoperative detector gamma probe,stratified by pathology results. |
| Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to FIGO stage. | Through study completion (an average of 36 months) | Detection rate and false negative rate of intraoperative detector gamma probe,stratified by FIGO stage. |
| Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to surgical approach. | Through study completion (an average of 36 months) | Detection rate and false negative rate of intraoperative detector gamma probe,stratified by surgical approach. |
| Evaluation of the performance of intraoperative Near Infrared (NIR) camera in the display of ovarian lymphatic map according to morphological characteristics | Through study completion (an average of 36 months) | Detection rate and false negative rate of intraoperative NIR camera,stratified by morphological characteristics |
| Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to pathology results. | Through study completion (an average of 36 months) | Detection rate and false negative rate of intraoperative NIR camera,stratified by pathology results. |
| Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to FIGO stage. | Through study completion (an average of 36 months) | Detection rate and false negative rate of intraoperative NIR camera,stratified by FIGO stage. |
| Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to biochemistry results. | Through study completion (an average of 36 months) | Detection rate and false negative rate of intraoperative NIR camera,stratified by biochemistry results. |
| Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to surgical approach. | Through study completion (an average of 36 months) | Detection rate and false negative rate of intraoperative NIR camera,stratified by surgical approach. |
| Anatomical distribution of sentinel lymph node detected with ICG. | Through study completion (an average of 36 months) | Anatomical location of sentinel lymph node according to ICG. |
| Anatomical distribution of sentinel lymph node detected with 99mTC albumin nanocolloid. | Through study completion (an average of 36 months) | Anatomical location of sentinel lymph node according to 99mTC albumin nanocolloid. |
| Comparison of lymph node detection with both tracers. | Through study completion (an average of 36 months) | Assessment of concordance of sentinel lymph node anatomical location detected with each tracer. |
| Evaluation of ultra-staging in micrometastases detection compared to conventional histology. | Through study completion (an average of 36 months) | 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 |
| Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to biochemistry results. | Through study completion (an average of 36 months) | Detection rate and false negative rate of intraoperative detector gamma probe,stratified by biochemistry results. |
| Evaluation of the complications associated with each technique. | Through study completion (an average of 36 months) | Chirurgic and post-operative complications, directly or indirectly associated to the use of the tracers. |
Countries
Spain
Contacts
CONTACTLaura Burunat, Graduate
PRINCIPAL_INVESTIGATORBerta Diaz-Feijoo, Physician
Hospital Clinic of Barcelona
PRINCIPAL_INVESTIGATORAureli Torné, Physician
Hospital Clinic of Barcelona
Outcome results
None listed