Sentinel Lymph Node Biopsy (SLNB)NCT07508306
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
An observational study of Sentinel Lymph Node Biopsy (SLNB) and Early Stage Ovarian Tumors, run by Faculty of Medicine of Tunis at 1 site in Tunisia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sentinel Lymph Node Biopsy (SLNB), Early Stage Ovarian Tumors
- What is being tested?
- Sentinel node biopsy with patent blue dye
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteTunisia
- Study dates
- 15 Apr 2026to 28 Feb 2028
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mohammed Amine Hannachi, Assistant professor contact
Tunisia1 site, 1 recruiting
- Recruiting
Maternity and neonatology center of Tunis
La Rabta, 1007
Hannachi Amine, 99696332, medaminehannachi3@gmail.com
medaminehannachi3@gmail.com
About this study
Official title: Evaluation of Sentinel Lymph Node Biopsy Using Patent Blue Dye in Early-Stage Ovarian Cancer: A Prospective Observational Study
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.
Read more
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.
Read the detailed description
Patients, with an early-stage ovarian cancer ESOC (FIGO stage I \& II), will be recruited. In our setting, the preoperative staging is based on :
- MRI finding (O-RADs classification 4 OR 5)
- Thoraco-abdominal CT scan
- Gastrointestinal endoscopy (if needed)
- Ovarian tumor biomarkers (CA 125, CA 19-9, Alpha-FP, HE4...) Or patients referred to our department for management of an ESOC with after an adnexectomy for ovarian mass.
These patients will receive a complete surgery for ovarian cancer : Peritoneal cytology, Bilateral adnexectomy, hysterectomy, pelvic lymphadenectomy, paraaortic lymphadenectomy, omentectomy and peritoneal biopsies.
Prior to the adnexectomy, surgeon will inject in subperitoneal space of the infundibular ligament (1 ml of patent blue dye: 0.5 ml in ventral and 0.5 ml in dorsal) and of the utero-ovarian ligament (1 ml of patent blue dye: 0.5 ml in ventral and 0.5 ml in dorsal). Then we will wait for 15 minutes: during which we will proceed to the adnexectomy. After 15 min, the retroperitoneal space of the pelvic and para-aortic regions was opened, and the presence of Sentinelle lymph Nodes (SLNs) was examined visually. The surgeon will record the number and location of the resected SLNs. Following the identification and removal of the SLNs, a complete systematic bilateral pelvic and para-aortic lymphadenectomy is performed. All specimen will be subject to histology analysis.
The collected data:
- PreOperative informations:
- Sociodemographic data : Age, Body Mass Index, Menopausal status..
- History: Family history of cancer, Comorbidity, surgical history..
- Ovarian tumor biomarkers
- PreOperative imaging: MRI, CT scan, Ultrasonography
- Presumed FIGO stage (I or II)
- Peri-operative data:
- SLN procedure: injection timing, Injected volume and site, Time to visual detection, site and number of detection
- Operative complications: vessel injury, nerve injury and allergic reaction to dye
- Pathological finding:
- tumor characterization: type (serous, mucinous,...), grade and tumor size
- SLN analysis: SLN frozen section, SLN final ultrastaging
- Non-SLN status after complete lymphadenectomy
- Final FIGO stage
- Post-operative follow-up
- Hospital stay duration
- Post-operative complications (within Clavien-Dindo classification)
- Adjuvant therapy
- Being tested
- Sentinel node biopsy with patent blue dye
- Keywords
- early stage ovarian cancer, sentinel lymph node, sentinel lymph node biopsy, Patent blue dye
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel node biopsy with patent blue dyeProcedure or surgery
Also called sentinel lymph node biopsy using patent blue dye for early stage ovarian cancer
Sentinel lymph node using patent blue dye for early ovarian cancer
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Sentinel node biopsy with patent blue dye |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From the procedure to the pathology results at 4 weeks
Secondary outcomes (3)
Negative predictive value
representing the probability that a negative SLN truly indicates that all other nodes in that drainage basin are free of disease
Measured: 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
Measured: From the procedure till the results of pathology at 4 weeks
Anatomical Distribution
Analysis of where the SLNs are located
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start15 Apr 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Sentinel Lymph Node Biopsy (SLNB)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Faculty of Medicine of Tunis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Amine HANNACHI, Faculty of Medicine of Tunis
- Investigators
- KHALED NEJI, Professor, Study chair, Maternity and neonatology center of Tunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07508306
- Sponsor's protocol ID
- MedSchoolTunisia
- Status last verified
- Sep 2026
- First submitted
- 22 Mar 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The only data that i will share is specified in study description: * PreOperative informations: * Sociodemographic data : Age, Body Mass Index, Menopausal status.. * History: Family history of cancer, Comorbidity, surgical history.. * Ovarian tumor biomarkers * PreOperative imaging: MRI, CT scan, Ultrasonography * Presumed FIGO stage (I or II) * Peri-operative data: * SLN procedure: injection timing, Injected volume and site, Time to visual detection, site and number of detection * Operative complications: vessel injury, nerve injury and allergic reaction to dye * Pathological finding: * tumor characterization: type (serous, mucinous,...), grade and tumor size * SLN analysis: SLN frozen section, SLN final ultrastaging * Non-SLN status after complete lymphadenectomy * Final FIGO stage * Post-operative follow-up * Hospital stay duration * Post-operative complications (within Clavien-Dindo) * adjuvant therapy
Publications
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.
PubMed 36408149Chen 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.
PubMed 34552868Wang 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.
PubMed 39511679Nero 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.
PubMed 38006759Ataei 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.
PubMed 38435483Agusti 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.
PubMed 35470254Laven 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.
PubMed 34645514Agusti 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.
PubMed 37487662Valenzuela-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.
PubMed 39952605Van 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.
PubMed 34562642Agusti 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.
PubMed 37980769Zhu 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.
PubMed 39206992Rey 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.
PubMed 39414311Rodrigues 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.
PubMed 36108452Bizzarri N, Nero C, Di Berardino S, Scambia G, Fagotti A. Future of sentinel node biopsy in ovarian cancer. Curr Opin Oncol. 2024 Sep 1;36(5):412-417. doi: 10.1097/CCO.0000000000001058. Epub 2024 Jul 16.
PubMed 39016276
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sentinel Lymph Node Biopsy Using Patent Blue Dye in Early-Stage Ovarian Cancer: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07508306
- Acronym / sponsor ID
- MedSchoolTunisia
- Keywords
- early stage ovarian cancer, sentinel lymph node, sentinel lymph node biopsy, Patent blue dye
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Faculty of Medicine of TunisUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients, with an early-stage ovarian cancer ESOC (FIGO stage I \& II), will be recruited. In our setting, the preoperative staging is based on :
- MRI finding (O-RADs classification 4 OR 5)
- Thoraco-abdominal CT scan
- Gastrointestinal endoscopy (if needed)
- Ovarian tumor biomarkers (CA 125, CA 19-9, Alpha-FP, HE4...) Or patients referred to our department for management of an ESOC with after an adnexectomy for ovarian mass.
These patients will receive a complete surgery for ovarian cancer : Peritoneal cytology, Bilateral adnexectomy, hysterectomy, pelvic lymphadenectomy, paraaortic lymphadenectomy, omentectomy and peritoneal biopsies.
Prior to the adnexectomy, surgeon will inject in subperitoneal space of the infundibular ligament (1 ml of patent blue dye: 0.5 ml in ventral and 0.5 ml in dorsal) and of the utero-ovarian ligament (1 ml of patent blue dye: 0.5 ml in ventral and 0.5 ml in dorsal). Then we will wait for 15 minutes: during which we will proceed to the adnexectomy. After 15 min, the retroperitoneal space of the pelvic and para-aortic regions was opened, and the presence of Sentinelle lymph Nodes (SLNs) was examined visually. The surgeon will record the number and location of the resected SLNs. Following the identification and removal of the SLNs, a complete systematic bilateral pelvic and para-aortic lymphadenectomy is performed. All specimen will be subject to histology analysis.
The collected data:
- PreOperative informations:
- Sociodemographic data : Age, Body Mass Index, Menopausal status..
- History: Family history of cancer, Comorbidity, surgical history..
- Ovarian tumor biomarkers
- PreOperative imaging: MRI, CT scan, Ultrasonography
- Presumed FIGO stage (I or II)
- Peri-operative data:
- SLN procedure: injection timing, Injected volume and site, Time to visual detection, site and number of detection
- Operative complications: vessel injury, nerve injury and allergic reaction to dye
- Pathological finding:
- tumor characterization: type (serous, mucinous,...), grade and tumor size
- SLN analysis: SLN frozen section, SLN final ultrastaging
- Non-SLN status after complete lymphadenectomy
- Final FIGO stage
- Post-operative follow-up
- Hospital stay duration
- Post-operative complications (within Clavien-Dindo classification)
- Adjuvant therapy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with preoperative diagnosis of early stage ovarian cancer (FIGO stage I & II ) | – | Procedure: Sentinel node biopsy with patent blue dyePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sentinel node biopsy with patent blue dyeAlso: sentinel lymph node biopsy using patent blue dye for early stage ovarian cancerSentinel lymph node using patent blue dye for early ovarian cancer | Procedure or surgery | Patients with preoperative diagnosis of early stage ovarian cancer (FIGO stage I & II ) |
Primary outcome
Technical feasibility
Time frame: From the procedure to the pathology results at 4 weeks
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
3 secondary outcomes
Negative predictive value
Time frame: From the procedure till the results of pathology at 4 weeks
Sensitivity
Time frame: From the procedure till the results of pathology at 4 weeks
Anatomical Distribution
Time frame: During the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 36408149Kampan 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.
- Background: PubMed 34552868Chen 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.
- Background: PubMed 39511679Wang 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.
- Background: PubMed 38006759Nero 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.
- Background: PubMed 38435483Ataei 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.
- Background: PubMed 35470254Agusti 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.
- Background: PubMed 34645514Laven 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.
- Background: PubMed 37487662Agusti 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.
- Background: PubMed 39952605Valenzuela-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.
- Background: PubMed 34562642Van 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.
- Background: PubMed 37980769Agusti 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.
- Background: PubMed 39206992Zhu 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.
- Individual participant dataSharing planned: No. The only data that i will share is specified in study description: * PreOperative informations: * Sociodemographic data : Age, Body Mass Index, Menopausal status.. * History: Family history of cancer, Comorbidity, surgical history.. * Ovarian tumor biomarkers * PreOperative imaging: MRI, CT scan, Ultrasonography * Presumed FIGO stage (I or II) * Peri-operative data: * SLN procedure: injection timing, Injected volume and site, Time to visual detection, site and number of detection * Operative complications: vessel injury, nerve injury and allergic reaction to dye * Pathological finding: * tumor characterization: type (serous, mucinous,...), grade and tumor size * SLN analysis: SLN frozen section, SLN final ultrastaging * Non-SLN status after complete lymphadenectomy * Final FIGO stage * Post-operative follow-up * Hospital stay duration * Post-operative complications (within Clavien-Dindo) * adjuvant therapy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohammed Amine Hannachi, Assistant professor contact
KHALED NEJI, Professor study chair
Maternity and neonatology center of Tunis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sentinel Lymph Node Biopsy (SLNB) and Early Stage Ovarian Tumors, run by Faculty of Medicine of Tunis at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Amine Hannachi, Assistant professor (+21699696332 ext. +216, medaminehannachi3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical feasibility (time frame: From the procedure to the pathology results at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07508306, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.