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
83
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]
Location Countries
Czechia
Location Countries
Czechia
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
March 2021