Tracers for Endometrial Cancer Sentinel Node Labeling

Brief Title

Tracers for Endometrial Cancer Sentinel Node Labeling

Official Title

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).

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.

Study Type

Interventional

Primary Outcome

SLN unilateral detection rate

Secondary Outcome

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

Condition

Endometrial Cancer

Intervention

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

Study Arms / Comparison Groups

 Early-stage endometrial cancer patients

Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

Start Date

January 1, 2021

Completion Date

January 1, 2024

Primary Completion Date

January 1, 2023

Eligibility Criteria

        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

Gender

Female

Ages

18 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

Maja Pakiž, MD,PhD, +38623212583, [email protected]

Administrative Informations

NCT ID

NCT04665544

Organization ID

CEEGOG EX-02

Responsible Party

Principal Investigator

Study Sponsor

University Medical Centre Maribor

Study Sponsor

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

Verification Date

December 2020