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

NCT07508306 | Recruiting DMC

• 1 other identifier: MedSchoolTunisia
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

the standard of care in case of early ovarian cancer (stage I or II) is a complete surgery. This surgery includes : hysterectomy (remove of the uterus), bilateral salpingo-oophorectomy (remove of the adnexa), omentectomy (remove of the epiploon), bilateral pelvic lymphadenectomy (remove of pelvic lymph nodes) and para-aortic lymphadenectomy (remove of para-aortic lymph nodes). This procedure is diagnostic, curative and prognostic surgery. In fact, it allows us provider care giver to stratify the stage of the cancer, hence we give the appropriate adjuvant therapy. However, this surgery, especially the extended lymphadenectomy, is associated with some risks: lymphocele, vessel injury, blood loss, morbidity, long recovery period ... In order to reduce these risks, we propose a sentinel lymph node biopsy. This intervention allows us to detect first lymph node relay whether pelvic or para-aortic. In our study, we chose the patent blue dye as a tracer. This tracer is widely used in oncologic surgery (for example in breast cancer) and approved but not in ovarian cancer yet. During surgery for early stage ovarian cancer, we will inject the patent blue dye on both side of the ovarian tumor. Then, we will check for first colorful lymph node, in both pelvic and para-aortic regions. We will send these dissected lymph node to pathology for analysis. Finally, we will continue the procedure as the standard of care. Our objective is to compare the results between the sentinel lymph node and the complete lymphadenectomy and to study the technique of sentinel lymph node biopsy using the blue patent dye as tracer.

Conditions

Sentinel Lymph Node Biopsy (SLNB); Early Stage Ovarian Tumors

Keywords

early stage ovarian cancer; sentinel lymph node; sentinel lymph node biopsy; Patent blue dye

Outcome Measures

Primary Outcomes (1)

• 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

  From the procedure to the pathology results at 4 weeks

Secondary Outcomes (3)

• Negative predictive value

  From the procedure till the results of pathology at 4 weeks

• Sensitivity

  From the procedure till the results of pathology at 4 weeks

• Anatomical Distribution

  During the procedure

Study Arms (1)

Patients with preoperative diagnosis of early stage ovarian cancer (FIGO stage I & II )

Patients with preoperative diagnosis (Using abdominal MRI and thoraco-abdomino-pelvic scan) of early stage ovarian cancer (FIGO stage I \& II ). Paitients with O-RADs 4 or 5 MRI ovarian tumors with or without elevated ovarian tumor markers.

Procedure: Sentinel node biopsy with patent blue dye

Interventions

Sentinel node biopsy with patent blue dye PROCEDURE

Sentinel lymph node using patent blue dye for early ovarian cancer

Also known as: sentinel lymph node biopsy using patent blue dye for early stage ovarian cancer

Patients with preoperative diagnosis of early stage ovarian cancer (FIGO stage I & II )

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient suspected with a FIGO Stage I or II ovarain cancer ( Based on MRI and scanner finding). Patients with planned for surgical complete stadification including pelvic and para-aortic lymphadenectomy.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Faculty of Medicine of Tunis: lead

Study Sites (1)

Maternity and neonatology center of Tunis

La Rabta, 1007, Tunisia

RECRUITING

Related Publications (19)

• Kampan NC, Teik CK, Shafiee MN. Where are we going with sentinel nodes mapping in ovarian cancer? Front Oncol. 2022 Nov 3;12:999749. doi: 10.3389/fonc.2022.999749. eCollection 2022.

  PMID: 36408149 BACKGROUND

• Chen J, Yin J, Li Y, Gu Y, Wang W, Shan Y, Wang YX, Qin M, Cai Y, Jin Y, Pan L. Systematic Lymph Node Dissection May Be Abolished in Patients With Apparent Early-Stage Low-Grade Mucinous and Endometrioid Epithelial Ovarian Cancer. Front Oncol. 2021 Sep 6;11:705720. doi: 10.3389/fonc.2021.705720. eCollection 2021.

  PMID: 34552868 BACKGROUND

• Wang H, Wang S, Wang P, Han Y. Survival outcomes of lymph node dissection in early-stage epithelial ovarian cancer: identifying suitable candidates. World J Surg Oncol. 2024 Nov 7;22(1):294. doi: 10.1186/s12957-024-03571-7.

  PMID: 39511679 BACKGROUND

• Nero C, Bizzarri N, Di Berardino S, Sillano F, Vizzielli G, Cosentino F, Vargiu V, De Iaco P, Perrone AM, Vizza E, Chiofalo B, Uccella S, Ghezzi F, Turco LC, Corrado G, Giannarelli D, Pasciuto T, Zannoni GF, Fagotti A, Scambia G. Sentinel-node biopsy in apparent early stage ovarian cancer: final results of a prospective multicentre study (SELLY). Eur J Cancer. 2024 Jan;196:113435. doi: 10.1016/j.ejca.2023.113435. Epub 2023 Nov 14.

  PMID: 38006759 BACKGROUND

• Ataei Nakhaei S, Sadeghi R, Mostafavi SM, Treglia G, Hassanzadeh M, Esmaeilpour M, Taheri NS, Farazestanian M. Sentinel Node Mapping in Ovarian Tumors: A Study Using Lymphoscintigraphy and SPECT/CT. Contrast Media Mol Imaging. 2024 Feb 23;2024:5453692. doi: 10.1155/2024/5453692. eCollection 2024.

  PMID: 38435483 BACKGROUND

• Agusti N, Paredes P, Vidal-Sicart S, Glickman A, Torne A, Diaz-Feijoo B. Sentinel lymph node mapping in early-stage ovarian cancer: surgical technique in 10 steps. Int J Gynecol Cancer. 2022 Aug 1;32(8):1082-1083. doi: 10.1136/ijgc-2022-003420. No abstract available.

  PMID: 35470254 BACKGROUND

• Laven P, Kruitwagen R, Zusterzeel P, Slangen B, van Gorp T, van der Pol J, Lambrechts S. Sentinel lymph node identification in early stage ovarian cancer: is it still possible after prior tumor resection? J Ovarian Res. 2021 Oct 13;14(1):132. doi: 10.1186/s13048-021-00887-w.

  PMID: 34645514 BACKGROUND

• Agusti N, Viveros-Carreno D, Grillo-Ardila C, Izquierdo N, Paredes P, Vidal-Sicart S, Torne A, Diaz-Feijoo B. Sentinel lymph node detection in early-stage ovarian cancer: a systematic review and meta-analysis. Int J Gynecol Cancer. 2023 Oct 2;33(10):1493-1501. doi: 10.1136/ijgc-2023-004572.

  PMID: 37487662 BACKGROUND

• Valenzuela-Mendez B, Bentivegna E, Bats AS, Azais H. Robotic Sentinel Lymph Node Dissection for Presumed Early-Stage Epithelial Ovarian Cancer Stadification by Transperitoneal and Retroperitoneal Approaches. J Minim Invasive Gynecol. 2025 Apr;32(4):316-317. doi: 10.1016/j.jmig.2024.12.017. Epub 2025 Feb 12.

  PMID: 39952605 BACKGROUND

• Van NT, Nguyen-Xuan HT, Koual M, Bentivegna E, Bats AS, Azais H. [Sentinel lymph node biopsy in the management of early-stage ovarian cancer: A systematic review of the literature]. Gynecol Obstet Fertil Senol. 2022 Jan;50(1):75-81. doi: 10.1016/j.gofs.2021.09.011. Epub 2021 Sep 22. French.

  PMID: 34562642 BACKGROUND

• Agusti N, Vidal-Sicart S, Paredes P, Celada-Castro C, Migliorelli F, Glickman A, Marina T, Fuste P, Carreras-Dieguez N, Saco A, Diaz-Feijoo B, Torne A. Mapping sentinel lymph nodes in early-stage ovarian cancer (MELISA) trial - a further step towards lymphadenectomy replacement. Gynecol Oncol. 2023 Dec;179:145-151. doi: 10.1016/j.ygyno.2023.11.007. Epub 2023 Nov 18.

  PMID: 37980769 BACKGROUND

• Zhu M, Li J, Lu L, Duan J, Jiang W. Lymph node metastasis in grossly apparent early-stage epithelial ovarian cancer: A retrospective clinical study at a tertiary institute. J Cancer Res Ther. 2024 Aug 1;20(4):1300-1305. doi: 10.4103/jcrt.jcrt_2489_23. Epub 2024 Aug 29.

  PMID: 39206992 BACKGROUND

• Rey I, Lago V, Arnaez M, Bizzarri N, Agusti N, Nero C, Diaz-Feijoo B, Padilla-Iserte P, Domingo S. Key issues in diagnostic accuracy of sentinel lymph node biopsy in early-stage ovarian cancer: systematic review and meta-analysis. Int J Gynecol Cancer. 2024 Nov 4;34(11):1787-1794. doi: 10.1136/ijgc-2024-005970.

  PMID: 39414311 BACKGROUND

• Rodrigues Teixeira F, Vertematti de Castro V, Chaves Faloppa C, Mantoan H, Yuri Kumagai L, Narcizo Oliveira Menezes A, Badiglian-Filho L, De Brot L, Tirapelli Goncalves B, Paiva Gadelha Guimaraes A, Baiocchi G. Impact of lymph node staging in presumed early-stage ovarian carcinoma. Eur J Obstet Gynecol Reprod Biol. 2022 Nov;278:6-10. doi: 10.1016/j.ejogrb.2022.08.027. Epub 2022 Sep 7.

  PMID: 36108452 BACKGROUND

• Bizzarri N,Nero C,Di Berardino S,Scambia G,Fagotti A

  BACKGROUND

• Zachou G, Yongue G, Chandrasekaran D. Feasibility of Sentinel Lymph Node Biopsy in Early-Stage Epithelial Ovarian Cancer: A Systematic Review and Meta-Analysis. Diagnostics (Basel). 2023 Oct 14;13(20):3209. doi: 10.3390/diagnostics13203209.

  PMID: 37892029 BACKGROUND

• Seon KE, Kim SW, Kim YT. Clinical relevance of sentinel lymph node biopsy in early ovarian cancer. Obstet Gynecol Sci. 2023 Nov;66(6):498-508. doi: 10.5468/ogs.23114. Epub 2023 Oct 11.

  PMID: 37821093 BACKGROUND

• Lago V, Arnaez M, Padilla-Iserte P, Guijarro-Campillo AR, Matute L, Gurrea M, Bello P, Domingo S. Alternatives of the pelvic sentinel lymph node migration pathway in early ovarian cancer: the simplest the best. Int J Gynecol Cancer. 2024 Apr 1;34(4):639-640. doi: 10.1136/ijgc-2023-004912. No abstract available.

  PMID: 37945057 BACKGROUND

• Wang J, Chen S, Zhong F, Zhu T, Zhao Y. A LASSO-derived prediction model for assessing the risk of lymph node metastasis in T1 and T2 epithelial ovarian cancer: an international retrospective cohort study. Int J Surg. 2023 Mar 27. doi: 10.1097/JS9.0000000000000065. Online ahead of print.

  PMID: 36974675 BACKGROUND

MeSH Terms

Interventions

Sentinel Lymph Node Biopsy

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques

Study Officials

• KHALED NEJI, Professor

  Maternity and neonatology center of Tunis

  STUDY CHAIR

Central Study Contacts

Mohammed Amine Hannachi, Assistant professor

CONTACT

+21699696332; medaminehannachi3@gmail.com

Khaled Neji, Professor

CONTACT

+21651352742; DRKHALEDNEJI21@GMAIL.COM

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: April 2, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): February 28, 2028
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)