Endometrial CancerTESLA-1NCT04665544
Tracers for Endometrial Cancer Sentinel Node Labeling
A study testing SLN side-specific detection rate using radioactive tracer with/without blue dye and ICG tracer. in people with Endometrial Cancer and Sentinel Lymph Node, run by University Medical Centre Maribor at 6 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Endometrial Cancer, Sentinel Lymph Node
- What is being tested?
- SLN side-specific detection rate using radioactive tracer with/without blue dye and ICG tracer.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 1 Jan 2021to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnancy
- Desire for fertility sparing
- History of pelvic or abdominal radiotherapy
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Czechia4 sites, 4 recruiting
- Recruiting
University Hospital Ostrava
Ostrava
Jaroslav Klat, jaroslav.klat@fno.cz
Aneta Neničkova, aneta.nenickova@fno.cz
- Recruiting
Charles University-First Faculty of Medicine, University Hospital Bulovka, Department of Gynecology and Obstetrics
Prague
Vladimir Student, vladimir.student@bulovka.cz
Hana Urbankova, hana.urbankova@bulovka.cz
- Recruiting
Gynecologic Oncology Center, Department of Obstetrics and Gynecology; First Faculty of Medicine, Charles University of Prague and General Hospital in Prague
Prague
David Cibula, MD, PhD, David.Cibula@vfn.cz
Renata Poncova, renata.poncova@vfn.cz
- Recruiting
KNTB Zlin
Zlín
Pavel Havelka, havelka@bnzlin.cz
Martina Hajdonova, Martina.Hajdonova@bnzlin.cz
Poland1 site, 1 recruiting
- Recruiting
Department of Gynecology, Gynecologic Oncology and Endocrinological Gynecology, Medical University of Gdansk
Gdansk
Dariusz Wydra, dwydra@uck.gda.pl
Anna Abacjew-Chmyeko, anabacjew@gumed.edu.pl
Slovenia1 site, 1 recruiting
- Recruiting
University Medical centre Maribor, Department for Gynecologic and Breast Oncology
Maribor, 2000
Maja Pakiž, PhD, maja.pakiz@ukc-mb.si
Andrej Cokan, MD, andrej.cokan@ukc-mb.si
About this study
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).
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
- Being tested
- SLN side-specific detection rate using radioactive tracer with/without blue dye and ICG tracer.
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLN side-specific detection rate using radioactive tracer with/without blue dye and ICG tracer.Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: SLN side-specific detection rate using radioactive tracer with/without blue dye and ICG tracer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
SLN unilateral detection rate
Number of hemipelvises where the SLN was found/number of all hemipelvises for each tracer and combination of tracers
Measured: 2 years
Secondary outcomes (4)
Sensitivity of SLN biopsy for pelvic lymph node staging. Anatomical localisation of detected SLN
Number of true positive LN/(number of true positive LN+number of false negative LN) for each tracer and combination of tracers
Measured: 2 years
Number of detected SLN.
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).
Measured: 2 years
Descriptive meassure: Anatomical localisation of detected SLN
Exact anatomical localisation of SLN (1-external iliac vessels, 2-internal iliac vessels, 3-obturator region, 4-paraaortic region, 5-presacral region).
Measured: 2 years
Bilateral detection rate.
The number of patients with bilateral SLN detection/the number of all patients for each tracer and combination of tracers
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Jan 2021
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Maribor
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maja Pakiz, University Medical Centre Maribor
- Investigators
- Maja Pakiž, MD,PhD, Study chair, University Medical Centre Maribor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665544
- Sponsor's protocol ID
- CEEGOG EX-02
- Acronym
- TESLA-1
- Status last verified
- Apr 2021
- First submitted
- 18 Nov 2020
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT04665544
- Acronym / sponsor ID
- TESLA-1 / CEEGOG EX-02
- Conditions
- Endometrial Cancer, Sentinel Lymph Node
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- University Medical Centre MariborUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early-stage endometrial cancer patients | Experimental | Procedure: SLN side-specific detection rate using radioactive tracer with/without blue dye and ICG tracer.* 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- Pregnancy
- Desire for fertility sparing
- History of pelvic or abdominal radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Early-stage endometrial cancer patients |
Primary outcome
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
4 secondary outcomes
Sensitivity of SLN biopsy for pelvic lymph node staging. Anatomical localisation of detected SLN
Time frame: 2 years
Number of detected SLN.
Time frame: 2 years
Descriptive meassure: Anatomical localisation of detected SLN
Time frame: 2 years
Bilateral detection rate.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maja Pakiž, MD,PhD study chair
University Medical Centre Maribor
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SLN side-specific detection rate using radioactive tracer with/without blue dye and ICG tracer. in people with Endometrial Cancer and Sentinel Lymph Node, run by University Medical Centre Maribor at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Czechia, Poland, Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maja Pakiž, MD, PhD (+38623212583, maja.pakiz@ukc-mb.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SLN unilateral detection rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.