Sentinel Lymph Node Biopsy in Early-Stage Ovarian Cancer

NCT05927818 | Recruiting DMC

• 1 other identifier: 1740514
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of this prospective study is to define the efficacy of the sentinel lymph node biopsy (SLNB) procedure by comparing it to the results obtained from systematic lymphadenectomy, each performed in participants with a suspicious adnexal mass for early-stage ovarian cancer.

Conditions

Sentinel Lymph Node; Ovarian Carcinoma

Outcome Measures

Primary Outcomes (1)

• Efficacy of sentinel lymph node biopsy in highly suspicious adnexal masses for early-stage ovarian cancer

  Sensitivity, specificity, positive and negative predictive value for sentinel lymph biopsy results (compared to lymph nodes collected by systemic lenfadenopathy) will be calculated. These calculations will be expressed in percentages and will be compared using appropriate statistical method.

  From the day of surgery to final pathology report (two weeks)

Study Arms (1)

Sentinel Lymph Node Biopsy and Systematic Lymph Node Dissection (Single Arm)

EXPERIMENTAL

This is a single arm interventional study in which the interventional and control arms are the same participant (each participant becomes its own control since the sentinel node biopsy- interventional arm - results are to be compared to systematic lymphadenectomy results-control arm). Intervention is injection of 2-4 mL sterile charcoal to the infundibulopelvic ligament or mesovarium of the suspicious adnexal mass followed by collection of stained sentinel lymph nodes and lymph nodes by systematic lymphadenectomy.

Diagnostic Test: Sentinel lymph node biopsy (using sterile charcoal stain) in early ovarian cancer

Interventions

Sentinel lymph node biopsy (using sterile charcoal stain) in early ovarian cancer DIAGNOSTIC_TEST

Described in previous sections

Also known as: Systematic lymphadenectomy

Sentinel Lymph Node Biopsy and Systematic Lymph Node Dissection (Single Arm)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have a suspicious adnexal mass for early stage ovarian cancer
• Must be medically and surgically fit enough to perform SLNB and complete the systematic lymphadenectomy.

You may not qualify if:

• Ovarian mass with low probability for early stage ovarian cancer.
• Medical or surgical contraindications for surgical comprehensive staging.
• Metastatic cancers or double primary cancers (metachronous) of ovary
• Recurrent ovarian cancer
• Preoperative or intraoperative finding of advanced ovarian cancer (FİGO stage III and IV)
• Neoadjuvant ovarian cancer

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University

Istanbul, Turkey, 34093, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• Negishi H, Takeda M, Fujimoto T, Todo Y, Ebina Y, Watari H, Yamamoto R, Minakami H, Sakuragi N. Lymphatic mapping and sentinel node identification as related to the primary sites of lymph node metastasis in early stage ovarian cancer. Gynecol Oncol. 2004 Jul;94(1):161-6. doi: 10.1016/j.ygyno.2004.04.023.

  PMID: 15262135 BACKGROUND

• Hassanzadeh M, Hosseini Farahabadi E, Yousefi Z, Kadkhodayan S, Zarifmahmoudi L, Sadeghi R. Lymphatic mapping and sentinel node biopsy in ovarian tumors: a study using intra-operative Tc-99m-Phytate and lymphoscintigraphy imaging. J Ovarian Res. 2016 Sep 7;9(1):55. doi: 10.1186/s13048-016-0265-4.

  PMID: 27604260 BACKGROUND

• Uccella S, Nero C, Vizza E, Vargiu V, Corrado G, Bizzarri N, Ghezzi F, Cosentino F, Turco LC, Fagotti A, Scambia G. Sentinel-node biopsy in early-stage ovarian cancer: preliminary results of a prospective multicentre study (SELLY). Am J Obstet Gynecol. 2019 Oct;221(4):324.e1-324.e10. doi: 10.1016/j.ajog.2019.05.005. Epub 2019 May 10.

  PMID: 31082385 BACKGROUND

• Lago V, Bello P, Montero B, Matute L, Padilla-Iserte P, Lopez S, Marina T, Agudelo M, Domingo S. Sentinel lymph node technique in early-stage ovarian cancer (SENTOV): a phase II clinical trial. Int J Gynecol Cancer. 2020 Sep;30(9):1390-1396. doi: 10.1136/ijgc-2020-001289. Epub 2020 May 23.

  PMID: 32448808 BACKGROUND

• Vanneuville G, Mestas D, Le Bouedec G, Veyre A, Dauplat J, Escande G, Guillot M. The lymphatic drainage of the human ovary in vivo investigated by isotopic lymphography before and after the menopause. Surg Radiol Anat. 1991;13(3):221-6. doi: 10.1007/BF01627990.

  PMID: 1754957 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

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

Central Study Contacts

Mustafa ALBAYRAK, MD

CONTACT

+90 532 687 10 51; mustafaalbayrak@icloud.com

Yagmur MİNARECİ, MD

CONTACT

+90 505 357 43 61; yagmurminareci@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No party in our clinical trial are prevented from having knowledge of the interventions assigned to individual participants.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Gynecologic Oncology Fellow

Model Details: A single arm interventional study aiming at the detection of the effectiveness of sentinel lymph node biopsy compared to systemic lymphadenectomy in participants who has high suspicion of an adnexal mass for early ovarian cancer clinically before operation in a single center. Clinical exam, radiological evaluation and tumor markers are primary determinants in using an adnexal mass to be assigned as 'highly suspicious'. The interventional and control arms are the same participant (each participant becomes its own control since the sentinel node biopsy- interventional arm - results are to be compared to systematic lymphadenectomy -control arm- results). Intervention is injection of 2-4 mL sterile charcoal to the infundibulopelvic ligament or mesovarium of the suspicious adnexal mass followed by collection of stained sentinel lymph nodes and lymph nodes by systematic lymphadenectomy.

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: July 3, 2023
• Study Start: April 15, 2023
• Primary Completion: October 15, 2025
• Study Completion: January 15, 2026
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

TU (1)