Tracers for Endometrial Cancer Sentinel Node Labeling (TESLA-1)

June 11, 2021 updated by: Maja Pakiz, University Medical Centre Maribor

Prospective Observational Study on Sentinel Node Biopsy Using Two Concurrent Labelling Techniques (Radioactive Tracer With/Without Blue Dye vs. Indocyanine Green-ICG) in Early-stage Endometrial Cancer Patients (TESLA-1).

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

83

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early-stage endometrial cancer patients
  • 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SLN unilateral detection rate
Time Frame: 2 years
Number of hemipelvises where the SLN was found/number of all hemipelvises for each tracer and combination of tracers
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of SLN biopsy for pelvic lymph node staging. Anatomical localisation of detected SLN
Time Frame: 2 years
Number of true positive LN/(number of true positive LN+number of false negative LN) for each tracer and combination of tracers
2 years
Number of detected SLN.
Time Frame: 2 years
Average number of detected SLN (in the specimen, labelled with the tracer, there might be one or more LN; the number of removed LN is one of the quality indicator).
2 years
Descriptive meassure: Anatomical localisation of detected SLN
Time Frame: 2 years
Exact anatomical localisation of SLN (1-external iliac vessels, 2-internal iliac vessels, 3-obturator region, 4-paraaortic region, 5-presacral region).
2 years
Bilateral detection rate.
Time Frame: 2 years
The number of patients with bilateral SLN detection/the number of all patients for each tracer and combination of tracers
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Maribor

Investigators

  • Study Chair: Maja Pakiž, MD,PhD, University Medical Centre Maribor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

November 18, 2020

First Submitted That Met QC Criteria

December 6, 2020

First Posted (Actual)

December 11, 2020

Study Record Updates

Last Update Posted (Actual)

June 14, 2021

Last Update Submitted That Met QC Criteria

June 11, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEEGOG EX-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Endometrial Cancer

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

  • University of Wisconsin, Madison
    National Cancer Institute (NCI); OnLume Inc.
    Completed
    ICG and SLN Mapping
    Breast Cancer
    United States

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