Patent Blue SLN in Early Ovarian Cancer Prospective Study (FIGO I-II) Evaluating Patent Blue SLN Mapping. Injection Into IP/UO Ligaments in Situ. Goals: Assess Feasibility and Accuracy vs Standard Lymphadenectomy to Minimize Surgical Morbidity

NCT07508306RecruitingOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

Faculty of Medicine of Tunis

Enrollment

30

Start Date

2026-04-15

Completion Date

2027-12-31

Study Type

OBSERVATIONAL

Official Title

Evaluation of Sentinel Lymph Node Biopsy Using Patent Blue Dye in Early-Stage Ovarian Cancer: A Prospective Observational Study

Interventions

Sentinel node biopsy with patent blue dye

Conditions

Sentinel Lymph Node Biopsy (SLNB)Early Stage Ovarian Tumors

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* Age : aged 18 years-old or older
* Diagnosis: Suspected Ovarian cancer on MRI finding (O-RADs 4 or 5)
* FIGO stage: Stage I or II ( Based on MRI and scanner finding)
* Planned Procedure: Patients with planned for surgical complete stadification including pelvic and para-aortic lymphadenectomy
* Consent: Signing of the written informed consent after full information has been provided

Exclusion Criteria:

* Suspicious nodal involvement: Presence of suspicious lymph nodes on preoperative imaging (generally defined by a short-axis diameter ≥ 10 mm).
* Disease extension: Radiological or intraoperative evidence of extra-pelvic metastases or peritoneal carcinomatosis.
* Surgical history: History of lymphadenectomy, lymph node sampling, or major vascular surgery involving the aorta or the iliac vessels.
* History of radiotherapy: Patients who have previously undergone pelvic or abdominal radiotherapy.
* Allergies: Known allergy or adverse reaction to patent blue dyes.

Outcome Measures

Primary Outcomes

Technical feasibility

Overall SLN Detection Rate: This is defined as the proportion of patients in whom at least one SLN is identified (either pelvic or para-aortic) using the blue tracer

Time frame: From the procedure to the pathology results at 4 weeks

Secondary Outcomes

Negative predictive value

representing the probability that a negative SLN truly indicates that all other nodes in that drainage basin are free of disease

Time frame: From the procedure till the results of pathology at 4 weeks

Sensitivity

The proportion of patients with node-positive disease correctly identified by the SLN technique

Time frame: From the procedure till the results of pathology at 4 weeks

Anatomical Distribution

Analysis of where the SLNs are located

Time frame: During the procedure

Locations

Maternity and neonatology center of Tunis, La Rabta, Tunisia

Linked Papers

2025-02-12

Robotic Sentinel Lymph Node Dissection for Presumed Early-Stage Epithelial Ovarian Cancer Stadification by Transperitoneal and Retroperitoneal Approaches

Epithelial ovarian cancer (EOC) is a significant global health concern. Early detection remains rare, with only 20% of cases identified at an early stage, highlighting the critical need for effective staging interventions [1]. Traditional extensive lymphadenectomy, associated with considerable morbidity, has led to the exploration of selective sentinel lymph node biopsy (SLNB), which is still under study [1-4]. SLNB, enhanced by robotic technology, is demonstrated through two clinical case studies studies that show how robotic systems are used to meticulously identify and map sentinel nodes, focusing on procedural specifics and fluorescence-guided node identification. The article synthesizes insights from recent studies [1-4], emphasizing the integration of robotic technology with SLNB to enhance surgical precision, improve recovery, and reduce morbidity. We examine SLNB through retroperitoneal and transperitoneal approaches, highlighting technical aspects and the benefits of robotic assistance over conventional laparoscopy, such as improved precision and ergonomics. A recent analysis and meta-analysis [1] showed a high pooled detection rate, though the evidence quality is low. Recently, the MELISA [3] and SELLY [2] studies were published, with MELISA showing higher detection, sensitivity, and specificity rates than SELLY. Sentinel lymph nodes vary in location, requiring meticulous exploration [1]. The retroperitoneal approach might offer an advantage for para-aortic dissection, particularly in obese patients, however, in sentinel lymph node biopsy, the need for extensive dissection could potentially limit its use [5]. Key technique aspects include injection zones and using combined tracers [2]. Limitations include variable detection rates, lack of standardized protocols, accessibility to robotic technology, and the need for advanced surgical skills [1]. SLNB, particularly with robotic assistance, shows promise for improving accuracy and reducing morbidity in epithelial ovarian cancer. However, its use remains limited to clinical trials. Future studies should focus on developing standardized protocols to achieve consistent results and provide sufficient evidence for its integration into routine clinical practice.

2024-11-07

Survival outcomes of lymph node dissection in early-stage epithelial ovarian cancer: identifying suitable candidates

The study aimed to assess the effect of lymph node dissection on survival outcomes in patients presenting with early-stage epithelial ovarian cancer and to delineate patient characteristics that may indicate a greater benefit from pelvic lymph node dissection. A retrospective analysis was performed on individuals diagnosed with clinical stage I-II epithelial ovarian cancer who received primary cytoreductive surgery at the Cancer Hospital Affiliated with Harbin Medical University from January 1, 2010, to January 1, 2018. The investigation encompassed an examination of demographic data, clinicopathological profiles, perioperative complications, and survival outcomes. A total of 315 patients diagnosed with ovarian cancer were incorporated into the study and were segregated into two distinct cohorts: 217 patients who underwent lymphadenectomy (Group A) and 98 patients who did not undergo the procedure (Group B). The disparities in progression-free survival and overall survival between the two cohorts did not attain statistical significance (p > 0.05). Upon conducting a subgroup analysis, it was discerned that patients characterized by clear cell carcinoma as the pathological subtype demonstrated a significantly extended progression-free survival post-lymphadenectomy (p = 0.02). Additionally, the operative duration for the patients in Group A was significantly protracted in comparison to Group B (146.15 ± 39.132 min vs. 133.49 ± 35.308 min, P = 0.043). For patients with early-stage ovarian cancer, lymph node dissection does not significantly improve progression-free or overall survival rates. Our findings suggest that individuals with clear cell carcinoma pathology have a higher probability of benefiting in terms of survival following lymph node dissection.

2024-08-29

Lymph node metastasis in grossly apparent early-stage epithelial ovarian cancer: A retrospective clinical study at a tertiary institute

ABSTRACT Objective: This study aimed to evaluate the incidence and predict the risk factors of lymph node (LN) metastasis among patients with grossly apparent early-stage epithelial ovarian cancer (EOC). Methods: We retrospectively reviewed the clinicopathologic data and follow-up information of 266 patients who underwent LN dissection for apparent early-stage EOC between January 2018 and September 2022 at the Obstetrics and Gynecology Hospital of Fudan University. Results: Among 266 patients, 44 (16.5%) showed LN metastasis, of which 65.9% and 59.1% presented in the pelvic region and para-aortic region, respectively. Univariate analysis revealed higher LN positivity in patients with high-grade serous carcinoma (HGSC), preoperative imaging suggestive of LN metastasis, bilateral adnexal involvement, lymphovascular space invasion (LVSI), positive peritoneal cytology, and clinical stage IIA. LN metastases were identified in 7.9%, 10.2%, and 39.7% of clinical stage IA/B, IC, and IIA disease cases, respectively. Multivariate analysis confirmed significantly higher LN positivity rates in patients with HGSC, LVSI, and clinical stage IIA. In clinical stage IIA EOC, the 3-year progression-free survival (PFS) rates were 65.8% and 77.4% (P = 0.360) for LN-negative and LN-positive groups, respectively. In clinical stage I EOC, the 3-year PFS rates were 93.5% and 59.4% (P < 0.001) for LN-negative and LN-positive groups, respectively. Conclusions: High-grade serous histology, LVSI, and clinical stage IIA disease are predictive factors for LN involvement in early-stage EOC. In addition, LN metastasis appears to be associated with worse PFS in clinical stage I EOC compared with clinical stage IIA EOC.

2024-02-23

Sentinel Node Mapping in Ovarian Tumors: A Study Using Lymphoscintigraphy and SPECT/CT

Purpose. Ovarian cancer in the early stage requires a complete surgical staging, including radical lymphadenectomy, implying subsequent risk of morbidity and complications. Sentinel lymph node (SLN) mapping is a procedure that attempts to reduce radical lymphadenectomy-related complications and morbidities. Our study evaluates the feasibility of SLN mapping in patients with ovarian tumors by the use of intraoperative Technetium-99m-Phytate (Tc-99m-Phytate) and postoperative lymphoscintigraphy using tomographic (single-photon emission computed tomography/computed tomography (SPECT/CT)) acquisition. Materials and Methods. Thirty-two patients with ovarian mass participated in this study. Intraoperative injection of the radiopharmaceutical was performed just after laparotomy and before the removal of tumor in utero-ovarian and suspensory ligaments of the ovary just beneath the peritoneum. Subsequently, pelvic and para-aortic lymphadenectomy was performed for malignant masses, and the presence of tumor in the lymph nodes was assessed through histopathological examination. Conversely, lymphadenectomy was not performed in patients with benign lesions or borderline ovarian tumors. Lymphoscintigraphy was performed within 24 hr using tomographic acquisition (SPECT/CT) of the abdomen and pelvis. Results. Final pathological examination showed 19 patients with benign pathology, 5 with borderline tumors, and 6 with malignant ovarian tumors. SPECT/CT identified SLNs in para-aortic-only areas in 6 (20%), pelvic/para-aortic areas in 14 (47%), and pelvic-only areas in 7 (23%) cases. Notably, additional unusual SLN locations were revealed in perirenal, intergluteal, and posterior to psoas muscle regions in three patients. We were not able to calculate the false negative rate due to the absence of patients with involved lymph nodes. Conclusion. SLN mapping using intraoperative injection of radiotracers is safe and feasible. Larger studies with more malignant cases are needed to better evaluate the sensitivity of this method for lymphatic staging of ovarian malignancies.

2023-11-18

Mapping sentinel lymph nodes in early-stage ovarian cancer (MELISA) trial - a further step towards lymphadenectomy replacement

Sistematic pelvic and para-aortic lymphadenectomy is part of the staging surgery for early-stage epithelial ovarian cancer, with no therapeutic value. The Mapping Sentinel Lymph Nodes In Early-Stage Ovarian Cancer (MELISA) trial prospectively assessed the SLN detection rate and the diagnostic accuracy of the SLN mapping technique in patients with early-stage epithelial ovarian cancer. This prospective, single-arm study included patients diagnosed with early-stage epithelial ovarian cancer (FIGO stages I and II), via either primary surgery or re-staging surgery. SLN mapping was performed by injecting 0.2 mL of 37-mBq Thirty patients were included. SLNs were identified in 27 patients (90%). Detection rates in primary and re-staging surgery were 89% and 92%, respectively. Para-aortic drainage was the predominant lymphatic spread, observed in 26 of 27 patients. Ultrastaging pathologic reports listed 1 SLN with macrometastasis, 1 with micrometastasis, and 5 with isolated tumor cells; the sensitivity of SLN mapping was 100%, with a false-negative rate of 0%. Univariate analysis showed a nonsignificant higher proportion of patients with uterine fibroids, adenomyosis, and endometriosis (100%, 67%, 67%, respectively) in patients in whom SLNs were not detected. SLN mapping has a high detection rate (90%) and is an accurate technique for detecting lymph node involvement in early-stage epithelial ovarian cancer. SLN mapping is a potential alternative to systematic lymphadenectomy to reduce associated morbidity, but further research is needed to evaluate the impact of SLN mapping on oncologic outcomes and its cost-effectiveness.

2023-11-14

Sentinel-node biopsy in apparent early stage ovarian cancer: final results of a prospective multicentre study (SELLY)

To evaluate the sensitivity and specificity of sentinel-lymph-node mapping compared with the gold standard of systematic lymphadenectomy in detecting lymph node metastasis in apparent early stage ovarian cancer. Multicenter, prospective, phase II trial, conducted in seven centers from March 2018 to July 2022. Patients with presumed stage I-II epithelial ovarian cancer planned for surgical staging were eligible. Patients received injection of indocyanine green in the infundibulo-pelvic and, when feasible, utero-ovarian ligaments and sentinel lymph node biopsy followed by pelvic and para-aortic lymphadenectomy was performed. Histopathological examination of all nodes was performed including ultra-staging protocol for the sentinel lymph node. 174 patients were enrolled and 169 (97.1 %) received study interventions. 99 (58.6 %) patients had successful mapping of at least one sentinel lymph node and 15 (15.1 %) of them had positive nodes. Of these, 11 of 15 (73.3 %) had a correct identification of the disease in the sentinel lymph node; 7 of 11 (63.6 %) required ultra-staging protocol to detect nodal metastasis. Four (26.7 %) patients with node-positive disease had a negative sentinel-lymph-node (sensitivity 73.3 % and specificity 100.0 %). In a multicenter setting, identifying sentinel-lymph nodes in apparent early stage epithelial ovarian cancer did not reach the expected sensitivity: 1 of 4 patients might have metastatic lymphatic disease unrecognized by sentinel-lymph-node biopsy. Nevertheless, 35.0 % of node positive patients was identified only thanks to ultra-staging protocol on sentinel-lymph-nodes.

2023-10-02

Sentinel lymph node detection in early-stage ovarian cancer: a systematic review and meta-analysis

A systematic pelvic and para-aortic lymphadenectomy remains the surgical standard management of early-stage epithelial ovarian cancer. Sentinel lymph node mapping is being investigated as an alternative procedure; however, data reporting sentinel lymph node performance are heterogeneous and limited. This study aimed to evaluate the detection rate and diagnostic accuracy of sentinel lymph node mapping in patients with early-stage ovarian cancer. A systematic search was conducted in Medline (through PubMed), Embase, Scopus, and the Cochrane Library. We included patients with clinical stage I-II ovarian cancer undergoing a sentinel lymph node biopsy and a pelvic and para-aortic lymphadenectomy as a reference standard. We conducted a meta-analysis for the detection rates and measures of diagnostic accuracy and assessed the risk of bias using the Quality Assessment of Diagnostic Accuracy Studies 2 tool. The study was registered in the International Prospective Register of Systematic Reviews (PROSPERO) with identifying number CRD42022351497. After duplicate removal, we identified 540 studies, 18 were assessed for eligibility, and nine studies including 113 patients were analyzed. The pooled detection rates were 93.3% per patient (95% CI 77.8% to 100%; I Sentinel lymph node biopsy in early-stage ovarian cancer showed a high detection rate and negative predictive value. The utero-ovarian and infundibulo-pelvic injection using the indocyanine green and technetium-99 combination could increase sentinel lymph node detection rates. However, given the limited quality of evidence and the small number of reports, results from ongoing trials are awaited before its implementation in routine clinical practice.

2022-09-07

Impact of lymph node staging in presumed early-stage ovarian carcinoma

Our objective was to analyze the prevalence of lymph node metastasis in early-stage ovarian carcinoma after systematic lymph node dissection and its impact on indication of adjuvant chemotherapy. We evaluated a series of 765 patients diagnosed with ovarian carcinoma who underwent surgical treatment from February 2007 to December 2019. Patients with peritoneal disease and incomplete surgical staging were excluded. All cases underwent systematic pelvic and para-aortic lymphadenectomy up to the renal vessels. A total of 142 cases were analyzed. Median pelvic and para-aortic lymph node dissected were 30 (range, 6-81) and 21 (range, 3-86), respectively. Twelve (8.4%) patients had metastatic lymph nodes - high-grade serous, 10.4% (5/48); clear cell, 17.2% (5/29) and endometrioid, 5.7% (2/35). Any other histology (low grade serous, mucinous, carcinosarcoma or mixed) had lymph node metastasis. Notably, 50% of patients with positive lymph nodes had preoperative suspicious lymph nodes in imaging. The median hospital stay length was 6 days (range, 2-33) and 4.2% cases had grade ≥ 3 complications. A total of 110 (77.6%) patients underwent adjuvant chemotherapy and all cases had indication of adjuvant chemotherapy after histological type, despite the lymph node status. After a median follow-up of 52.5 months, we noted 24 (16.9%) recurrences. The 5-year recurrence-free survival and overall survival were 86.4% and 98.1%, respectively. High grade histology was the only variable that negatively impacted disease-free survival in univariate analysis [HR 4.70 (95%CI: 1.09-20); p = 0.037]. We found a positive lymph node rate of less than 10% after lymphadenectomy in presumed early-stage ovarian carcinoma. Lymph node status was not determinant for adjuvant chemotherapy.

Linked Investigators

Giuseppe Vizzielli

- December 2021 - at present: Associate Professor in Gynecology and Obstetrics, Department of Medicine, University of Udine, University Hospital of Udine, Italy. - April 2021 – November 2021: Medical Doctor at Clinic of Obstetrics and Gynecology - "Santa Maria della Misericordia" University Hospital, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy - April 2015 - April 2021: Medical Doctor at “Fondazione Policlinico Universitario“Agostino Gemelli”, IRCCS, Catholic University of the Sacred Heart, Rome, Italy. - January 2014 - November 2014: Medical Doctor at “Fondazione di Ricerca e Cura "Giovanni Paolo II", Catholic University of the Sacred Heart, Campobasso, Italy. Member of the Italian Society of Gynaecological Endoscopy (SEGI) affiliated with the European Society of Gynecologic Endoscopy (ESGE). A national representative for gynecologists of the Italian Polyspecialist Society of Young Surgeons (SPIGC) and the Italian Society of Gynecology and Obstetrics (SIGO-YOUNG). Author of more than 150 peer-reviewed papers (www.pubmed.com) with an H-Index of 33 (by Scopus) and with more than 2000 citations (by Scopus). Principal Investigator and Co-Investigator of many phase I/II/III clinical trials in gynecologic oncology. Principal Investigator of the National research project, Call 2019. Project code: GR-2019-12371435. Project Title: Longitudinal genomic and transcriptomic analysis on ovarian cancer organoids. Project ID: TAILOR (Protocol number: 11959/20, Protocol ID: 3046). ClinicalTrials.gov Identifier: NCT04555473. Faculty of national and international standardized training programs for advanced laparoscopic and/or robotic gynecological surgery. Expert in gynecologic oncology, especially in studying advanced ovarian cancer, endometrial and cervical carcinoma. More recently, he has dedicated himself to studying radical pelvic surgery and pharmacological tests on gynecologic tumors by ex-vivo tissues. Official reviewer of many indexed international journals as well as Lancet Oncology, European Journal of Surgical Oncology, World Journal of Surgical Oncology, European Journal of Obstetrics and Gynecology and Reproductive Biology, Archives of Gynecology and Obstetrics, Case Reports in Obstetrics and Gynecology, Chinese Journal of Cancer Research, BMC Cancer. Associated Editor of Frontiers in Oncology (Women’s cancer and Gynecologic Oncology subsection), BMC Cancer, and World Journal of Surgical Oncology.