Tracers for Endometrial Cancer Sentinel Node Labeling

NCT04665544 | Unknown

• 1 other identifier: CEEGOG EX-02
• Study Type: interventional
• Target: 83
• Locations: 3 countries
• Sites: 6

Brief Summary

Sentinel lymph node (SLN) biopsy is currently used in the management of vulvar and breast cancers as well as in malignant melanoma, and is being intensively studied in patients with cervical and endometrial cancers. The role of lymphadenectomy in the surgical management of early-stage endometrial cancer is still controversial. The main reason to perform a SLN biopsy is to detect the lymph node that will be the first involved with metastatic disease in the nodal basin. The SLN biopsy is performed after the SLN is located with the use of different tracers in a concept called SLN mapping. Moreover, SLN evaluation has been reported to improve the accuracy of lymph node staging due to SLN pathologic ultrastaging, which includes multiple serial sectioning and immunohistochemical assessment. The aim of this project is to conduct a multicentre, prospective, observational trial to compare two different SLN labelling methods (radioactive tracer with/without blue dye vs. indocyanine green-ICG) in the same patient and to evaluate the unilateral detection rate, sensitivity, number of detected SLN, anatomical localisation of detected SLN and bilateral detection rate of SLN. The main aim of the trial is the comparison of SLN mapping between two SLN labelling methods in the same patient. The trial will answer a question whether a combination of labelling methods in the same patient increase importantly the sensitivity of SLN biopsy. The trial has a high potential to reach the calculated number of cases and thus bring in evidence/data that will be essential for future management of SLN biopsies in endometrial cancer.

Conditions

Endometrial Cancer; Sentinel Lymph Node

Outcome Measures

Primary Outcomes (1)

• SLN unilateral detection rate

  Number of hemipelvises where the SLN was found/number of all hemipelvises for each tracer and combination of tracers

  2 years

Secondary Outcomes (4)

• Sensitivity of SLN biopsy for pelvic lymph node staging. Anatomical localisation of detected SLN

  2 years

• Number of detected SLN.

  2 years

• Descriptive meassure: Anatomical localisation of detected SLN

  2 years

• Bilateral detection rate.

  2 years

Study Arms (1)

Early-stage endometrial cancer patients

EXPERIMENTAL

* Histologically proven endometrial cancer (any tumour type). * Apparent early-stage endometrial cancer with intermediate or high risk prognostic factors (deep myometrial invasion or G2/G3 disease or non- endometrioid histological type), no evidence of bulky or suspicious pelvic/para-aortic lymph nodes or distant metastases on preoperative conventional imaging studies; minimum requirement for clinical staging includes expert US or pelvic MRI for local staging and abdominal US or abdominal CT scan or PET CT for distant staging. * Performance status ECOG: 0-1. * Age ≥18, ≤85. * History of second primary cancer only if more than 5 years with no evidence of disease. * Approved and signed informed consent

Procedure: SLN side-specific detection rate using radioactive tracer with/without blue dye and ICG tracer.

Interventions

SLN side-specific detection rate using radioactive tracer with/without blue dye and ICG tracer. PROCEDURE

The primary objective of this study is to compare SLN detection rate using two types of intracervical tracers (radioactive tracer with or without blue dye vs. ICG). The null hypothesis is that the detectionrate does not differ between the two techniques.

Early-stage endometrial cancer patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven endometrial cancer (any tumour type).
• Apparent early-stage endometrial cancer with intermediate or high risk prognostic factors (deep myometrial invasion or G2/G3 disease or non- endometrioid histological type), no evidence of bulky or suspicious pelvic/para-aortic lymph nodes or distant metastases on preoperative conventional imaging studies; minimum requirement for clinical staging includes expert US or pelvic MRI for local staging and abdominal US or abdominal CT scan or PET CT for distant staging.
• Performance status ECOG: 0-1.
• Age ≥18, ≤85.
• History of second primary cancer only if more than 5 years with no evidence of disease.
• Approved and signed informed consent form to participate in the study.

You may not qualify if:

• Pregnancy
• Desire for fertility sparing
• History of pelvic or abdominal radiotherapy

Sponsors & Collaborators

• University Medical Centre Maribor: lead

Study Sites (6)

University Hospital Ostrava

Ostrava, Czechia

RECRUITING

Charles University-First Faculty of Medicine, University Hospital Bulovka, Department of Gynecology and Obstetrics

Prague, Czechia

RECRUITING

Gynecologic Oncology Center, Department of Obstetrics and Gynecology; First Faculty of Medicine, Charles University of Prague and General Hospital in Prague

Prague, Czechia

RECRUITING

KNTB Zlin

Zlín, Czechia

RECRUITING

Department of Gynecology, Gynecologic Oncology and Endocrinological Gynecology, Medical University of Gdansk

Gdansk, Poland

RECRUITING

University Medical centre Maribor, Department for Gynecologic and Breast Oncology

Maribor, 2000, Slovenia

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Maja Pakiž, MD,PhD

  University Medical Centre Maribor

  STUDY CHAIR

Central Study Contacts

Maja Pakiž, MD, PhD

CONTACT

+38623212583; maja.pakiz@ukc-mb.si

Andraž Dovnik, MD, PhD

CONTACT

+38623212178; andraz.dovnik@ukc-mb.si

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: Dr.

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: December 11, 2020
• Study Start: January 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2024
• Last Updated: June 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1); CZ (4); SL (1)