Ovarian Epithelial Cancer Clinical Trial
— Melisa-IIOfficial title:
Sentinel Node Detection With Technetium-99m Albumin Nanocolloid and Indocyanine Green (ICG) in Patients With Epithelial Ovarian Cancer in Early Stages: Pilot Study
Study to evaluate the diagnostic precision of ICG and 99mTc nanocolloid albumin in sentinel lymph node detection in early ovarian epithelial cancer.
Status | Not yet recruiting |
Enrollment | 62 |
Est. completion date | October 2026 |
Est. primary completion date | October 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Fundacion Clinic per a la Recerca Biomédica |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) |
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