Clinical trial NCT04665544: 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).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometrial Cancer
Sentinel Lymph Node
Lead sponsor: University Medical Centre Maribor
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 83
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: SLN unilateral detection rate
timeFrame: 2 years
Secondary outcomes:
measure: Sensitivity of SLN biopsy for pelvic lymph node staging. Anatomical localisation of detected SLN
timeFrame: 2 years
measure: Number of detected SLN.
timeFrame: 2 years
measure: Descriptive meassure: Anatomical localisation of detected SLN
timeFrame: 2 years
measure: Bilateral detection rate.
timeFrame: 2 years
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
city: Praha
country: Czechia
facility: Charles University-First Faculty of Medicine, University Hospital Bulovka, Department of Gynecology and Obstetrics
city: Praha
country: Czechia
facility: Gynecologic Oncology Center, Department of Obstetrics and Gynecology; First Faculty of Medicine, Charles University of Prague and General Hospital in Prague
city: Zlin
country: Czechia
facility: KNTB Zlin
city: Gdańsk
country: Poland
facility: Department of Gynecology, Gynecologic Oncology and Endocrinological Gynecology, Medical University of Gdansk
city: Maribor
country: Slovenia
facility: University Medical centre Maribor, Department for Gynecologic and Breast Oncology
Study officials:
affiliation: University Medical Centre Maribor
name: Maja Pakiž, MD,PhD
role: STUDY_CHAIR
References: