Mapping Sentinel Lymph Node in Initial Stages of Ovarian Cancer

NCT05184140 | Unknown DMC

• 1 other identifier: HCB/2021/0130
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Epithelial ovarian cancer (EOC) diagnosed in the initial stage (stage I-II) require complete staging surgery to histologically assess the possible existence of peritoneal or lymph node disease. Systematic pelvic and paraaortic lymphadenectomy in stage I-II EOC is essential since confirming the presence of lymph node metastases means re-staging the disease as stage III. This change of stage has important prognostic and therapeutic implications. However, the lymph node involvement rate is around 10-30% (average of 15%). Systematic pelvic and para-aortic lymphadenectomy carries a risk of intraoperative complications, as well as longer operative time, postoperative complications and longer hospital stay. Moreover, by now there is no evidence suggesting a possible therapeutic value. The sentinel lymph node (SLN) detects the first level of lymph node drainage. The absence of metastases in the SLN predicts the absence of tumor infiltration of the rest of lymph nodes of the same anatomical region and allows to safely avoid lymphadenectomy and its associated morbidity. In addition, the exhaustive evaluation of the SLN by ultrastaging and immunohistochemical study allows to increase the detection of microscopic disease. Sentinel lymph node (SLN) biopsy, implemented in clinical practice in other gynecological tumors (breast, vulva, cervix or endometrium), has been studied very little in the initial ovarian epithelial cancer. Unlike other gynecological tumors, there are multiple anatomical and technical aspects that largely explain this lack of information. The double ovarian vascularization that accompanies lymphatic drainage explains this higher complexity. Therefore, at the present time, the detection of SLN in the initial EOC remains an experimental area without applicability in clinical practice. There are multiple doubts and issues to be resolved regarding the different tracers, the site and time injection and the actual accuracy of the SLN versus the lymphadenectomy.

Conditions

Ovarian Cancer; Sentinel Lymph Node

Keywords

Ovarian Cancer; Sentinel Lymph Node

Outcome Measures

Primary Outcomes (1)

• Detection rate of sentinel node technique

  Detection of SLN in initial epithelial ovarian cancer by assessing the concordance of the result between the lymph node metastases and the lymphadenectomy

  Through study completion, an average of 2 years

Secondary Outcomes (7)

• Tracer specific detection rate

  2 years

• Tracer-related adverse events

  1 month

• False negative rate and negative predictive value

  2 years

• Anatomical location of the sentinel lymph node

  2 years

• Detection rate of gamma-camera, gamma-probe and Infrared fluorescence camera

  2 years

Other Outcomes (1)

• Evaluation of sentinel lymph node technique

  Through study completion, an average of 2 years

Study Arms (1)

Adnexal mass with high suspicion of malignancy

EXPERIMENTAL

An ovarian lymphatic map will be performed in patients with adnexal masses suspected of malignancy. Sentinel node exeresis and a complete staging surgery (including pelvic and para-aortic lymphadenectomy) will be performed in patients with ovarian cancer confirmation including restaging surgeries.

Procedure: Sentinel node detection

Interventions

Sentinel node detection PROCEDURE

Injection of the radiotracer to infundibulo-pelvic and utero-ovarian ligament in patients with high suspicion of malignancy adnexal mass. Injection of green indocyanine r to infundibulo-pelvic and utero-ovarian stumps only in case of malignancy after the adnexectomy. Sentinel node exeresis and a complete staging surgery (including pelvic and para-aortic lymphadenectomy) will be performed in patients with ovarian cancer diagnosis.

Also known as: Complete staging surgery

Adnexal mass with high suspicion of malignancy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a diagnosis of adnexal mass with high suspicion of malignancy and frozen section examination will undergo the lymphatic map with a radiotracer.
• Patients with intraoperative diagnosis of epithelial ovarian cancer will undergo the SLN exeresis with two tracers.
• Patients with a delayed diagnosis of epithelial ovarian cancer who are candidates to undergo a re-staging surgery will undergo the SLN exeresis with two tracers.

You may not qualify if:

• Advanced ovarian cancer (FIGO III/IV)
• Patients \<18 years
• Pregnancy or lactation
• Previous vascular surgery (cava, aorta, iliac vessels), lymphadenectomy (pelvic or paraortic) or radiotherapy (pelvic or paraortic field)
• Severe adherent syndrome that prevents tracer injection
• The SLN technique will not be performed in case of benign ovarian tumor in the frozen section or borderline tumor (since in these cases there is no clinical indication of performing a lymphadenectomy)
• Non-operable patient
• Previous adverse events to the radiotracer or ICG

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• Berta Diaz-Feijoo: collaborator
• Aureli Torné: collaborator
• Pilar Paredes: collaborator
• Sergi Vidal-Sicart: collaborator
• Ariel Glickman: collaborator
• Pere Fusté: collaborator
• Tiermes Marina: collaborator
• Francisco Campos: collaborator

Study Sites (1)

Núria Agustí Garcia

Barcelona, 08014, Spain

RECRUITING

Related Links

• Sentinel lymph node mapping in early-stage ovarian cancer: surgical technique in 10 steps

MeSH Terms

Conditions

Ovarian Neoplasms

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

Study Officials

• Aureli Torné, PhD

  Hospital Clinic of Barcelona

  STUDY DIRECTOR

• Berta Díaz-Feijóo, PhD

  Hospital Clinic of Barcelona

  STUDY DIRECTOR

Central Study Contacts

Núria Agustí, MD

CONTACT

+34 932 27 54 00; nagusti@clinic.cat

Pilar Paredes, PhD

CONTACT

pparedes@clinic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Controlled, prospective, descriptive

Study Record Dates

• First Submitted: December 4, 2021
• First Posted: January 11, 2022
• Study Start: January 1, 2021
• Primary Completion: April 1, 2023
• Study Completion: May 1, 2023
• Last Updated: March 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The data will become available One year after publication, and they will be available for 6 months.
• Access Criteria: Direct request to the study PI

Locations

ES (1)