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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional arm | Experimental | All patients will receive an injection of ICG and an injection of 99mTc nanocolloid albumin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 99mTC nanocolloid albumin injection | Diagnostic Test | All patients will receive an injection of both tracers in order to detect the sentinel lymph node |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Burunat, Graduate | Contact | 0034 932275400 | 4198 | burunat@recerca.clinic.cat |
| Name | Affiliation | Role |
|---|---|---|
| Berta Diaz-Feijoo, Physician | Hospital Clinic of Barcelona | Principal Investigator |
| Aureli Torné, Physician | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laura Burunat | Recruiting | Barcelona | Catalonia | 08036 | Spain |
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| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ICG injection | Diagnostic Test | All patients will receive an injection of both tracers in order to detect the sentinel lymph node |
|
| 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):
| 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) |
| D010051 |
| Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |