Sentinel Lymph NodeNCT06163963
Sentinel Lymph Node in Early-Stage Endometrium Cancer
A study testing Sentinel Lymph Node Mapping With Double Tracer and Double Injection Sites in Early-Stage Endometrium Cancer and charcoal injection to uterus to map sentinel lymph nodes in people with Sentinel Lymph Node and Endometrial Cancer, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this prospective study is to investigate whether the detection rate of sentinel lymph node (SLN) with double tracer injected at two different sites may be increased compared to the standard use of a single tracer with single site (cervix) injection in early-stage endometrial cancer. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Sentinel Lymph Node, Endometrial Cancer
- What is being tested?
- Sentinel Lymph Node Mapping With Double Tracer and Double Injection Sites in Early-Stage Endometrium Cancer and charcoal injection to uterus to map sentinel lymph nodes
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2023to May 2026
- 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 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have preoperative histologic diagnosis of endometrial carcinoma
- Must be in early stage ( stage1 and 2) endometrial carcinoma radiologically and clinically
- Must have written informed consent
Who cannot join
- Possible allergic reaction to commonly used drugs
- Medical or surgical contraindications for comphrensive staging
- Preoperative or intraoperative findings of advanced endometrial cancer
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University Medical Faculty Dept. of Obstet Gynecol, Division of Gynecologic Oncology
Istanbul, Istanbul / Turkey, 34093
Mustafa ALBAYRAK, MD, +905326871051, mustafaalbayrak@icloud.com
Yagmur MINARECI, MD, +905053574361, yagmurminareci@gmail.com
About this study
Official title: Sentinel Lymph Node Mapping with Double Tracer and Double Injection Sites in Early-Stage Endometrium Cancer
The aim of this prospective study is to investigate whether the detection rate of sentinel lymph node (SLN) with double tracer injected at two different sites may be increased compared to the standard use of a single tracer with single site (cervix) injection in early-stage endometrial cancer.
Read the detailed description
Endometrial cancer is the most common gynecologic cancer. Although 85-90% of women are diagnosed at early stage, about 10-15% are diagnosed at advanced stages. Treatment and prognosis depends on the surgical staging of the apparently early stage disease including the evaluation of lymphatic status of the disease. Detection of positive lymph node upstages the apparently early stage endometrial cancer. However, systematic lymphadenectomy carries immediate and long term risks for patients including bleeding, massive transfusions, prolongation of operation time, serious major vessel and major abdominal organ injury and death. These risks are especially increased in para-aortic lymphadenectomy which is a part of staging procedure in apparently early stage endometrial cancer.
Sentinel lymph node biopsy (SLNB) procedure is the biopsy of one or two lymph node(s) which represents the lymph node basin draining the area of malignancy. This biopsy may potentially eliminate the need systemic pelvic / para-aortic lymphadenectomy which harbours potential complications. Although SLNB became an standard procedure in endometrial cancer, available data on the SLNB in endometrial cancer is variable. The relevant literature suggests that the detection rate of sentinel lymph node using various tracer agents are between %70-98, even with lower for bilateral pelvic detection and para-aortic sentinel lymph node(s). The most commonly used tracer agents are methylene blue, radiolabeled colloid technetium 99 (Tc99), isosulfan blue and fluorescent indocyanine green. Although subserosal, intramyometrial uterine injections and peritumoral injections using hysteroscopy with different tracers and different detection rates have been used, cervical injection with ICG is the most favoured and standard technique with highest pelvic SLN detection rates. However, the para-aortic SLN detection rates are not satisfactory with a single tracer injected into cervix which may be critical especially in high grade endometrioid, serous and clear cell histological types.
So, investigators aimed to investigate whether the sentinel lymph node detection rates may be improved with double tracer injected at two different sites (charcoal carbon black dye injected in subserosa and ICG injected into cervix) compared to standard single tracer injected in early-stage endometrial cancer, especially the para-aortic sentinel lymph nodes. Sterile charcoal carbon black dye is an agent previously used for sentinel lymph node detection in various cancers such as breast cancer.
Technically, 2 mL indocyanine green with sterile water is injected at 3 and 9 o'clocks (each 1 mL) of cervix before the start of laparoscopic operation. Additionally, 2-4 mL of sterile charcoal carbon black dye is carefully injected just beneath the serosal layer at uterine fundus bilaterally avoiding intravascular injection This is done classically during laparoscopy by a spinal needle introduced under optical supervision after all optical and operative instruments are entered. 10-15 minute interval is allowed before the start of harvesting sentinel lymph nodes in pelvic and paraaortic region.
- Conditions
- Sentinel Lymph Node, Endometrial Cancer
- Being tested
- Sentinel Lymph Node Mapping With Double Tracer and Double Injection Sites in Early-Stage Endometrium Cancer, charcoal injection to uterus to map sentinel lymph nodes
- Keywords
- double tracer, endometrial cancer, sentinel lymph node
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel Lymph Node Mapping With Double Tracer and Double Injection Sites in Early-Stage Endometrium CancerDiagnostic test
This is a single arm interventional prospective study. Sentinel lymph node detection rate of the tracer injected in cervix (ICG- indocyanine green) before operation and the second tracer injected in uterine fundal subserosa (sterile charcoal black) at the start of operation are investigated. It is anticipated that additional tracer used in the uterine serosa may overcome the insufficiency (or increase the detection rate) of the standard single tracer injected in cervix for detection rate of sentinel lymph nodes, especially in paraaortic sentinel lymph nodes.
charcoal injection to uterus to map sentinel lymph nodesDiagnostic test
During surgery for endometrial cancer, charcoal injection to uterus to map sentinel lymph nodes in para aortic area besides the classic ınjection of indocyanine green for pelvic sentinel lymph node mapping.
| Study group | Role | What they receive |
|---|---|---|
| Sentinel Lymph Node Mapping With Double Tracer in Endometrium Cancer (Single Arm) | Experimental | Sentinel Lymph Node Mapping With Double Tracer and Double Injection Sites in Early-Stage Endometrium Cancer (Single Arm) Receives: Diagnostic Test: Sentinel Lymph Node Mapping With Double Tracer and Double Injection Sites in Early-Stage Endometrium Cancer; Diagnostic Test: charcoal injection to uterus to map sentinel lymph nodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of sentinel lymph nodes with double tracer in early stage endometrial carcinoma
Detection rates of sentinel lymph nodes for both tracers in every pelvic and paraaortic lymph node basin are the primary outcome of the study.Sentinel lymph node detection rates of each region (pelvic, obturator, inframesenteric para-aortic, supra-mesenteric - infrarenal para-aortic), bilaterality/ unilaterality and staining with single or double tracer will be discussed compared to literature data.
Measured: From the day of surgery to final pathology report (2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start1 Jul 2023
- Primary completionNov 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Sentinel Lymph NodeStudies 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
- Model description
- A single arm interventional study aiming at the comparison of the effectiveness of detection for sentinel lymph node biopsy using double tracer compared to classic single tracer in early stage endometrial cancer. So, we aimed to investigate whether the sentinel lymph node detection rates may be improved with double tracer injected at two different sites (charcoal carbon black dye injected in subserosa and ICG injected into cervix) compared to standard single tracer injected in early-stage endometrial cancer, especially the para-aortic sentinel lymph nodes. Sterile charcoal carbon black dye is an agent previously used for sentinel lymph node detection in various cancers such as breast cancer. Sentinel lymph node detection rates of each region (pelvic, obturator, inframesenteric para-aortic, supra-mesenteric - infrarenal para-aortic), bilaterality/ unilaterality and staining with single or double tracer will be discussed compared to literature data.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Albayrak, Istanbul University
- Investigators
- Samet TOPUZ, PROF. DR., Study director, ISTANBUL UNİVERSİTY MED FAC DEPT. OF OBSTET AND GYNECOL. DIVISION OF GYNECOLOGİC ONCOLOGY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163963
- Sponsor's protocol ID
- 2023/2015
- Status last verified
- Dec 2023
- First submitted
- 1 Dec 2023
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Crosbie EJ, Kitson SJ, McAlpine JN, Mukhopadhyay A, Powell ME, Singh N. Endometrial cancer. Lancet. 2022 Apr 9;399(10333):1412-1428. doi: 10.1016/S0140-6736(22)00323-3.
PubMed 35397864Cibula D, Oonk MH, Abu-Rustum NR. Sentinel lymph node biopsy in the management of gynecologic cancer. Curr Opin Obstet Gynecol. 2015 Feb;27(1):66-72. doi: 10.1097/GCO.0000000000000133.
PubMed 25502426Lee YC, Lheureux S, Oza AM. Treatment strategies for endometrial cancer: current practice and perspective. Curr Opin Obstet Gynecol. 2017 Feb;29(1):47-58. doi: 10.1097/GCO.0000000000000338.
PubMed 27941361van den Heerik ASVM, Horeweg N, de Boer SM, Bosse T, Creutzberg CL. Adjuvant therapy for endometrial cancer in the era of molecular classification: radiotherapy, chemoradiation and novel targets for therapy. Int J Gynecol Cancer. 2021 Apr;31(4):594-604. doi: 10.1136/ijgc-2020-001822. Epub 2020 Oct 20.
PubMed 33082238Holloway RW, Abu-Rustum NR, Backes FJ, Boggess JF, Gotlieb WH, Jeffrey Lowery W, Rossi EC, Tanner EJ, Wolsky RJ. Sentinel lymph node mapping and staging in endometrial cancer: A Society of Gynecologic Oncology literature review with consensus recommendations. Gynecol Oncol. 2017 Aug;146(2):405-415. doi: 10.1016/j.ygyno.2017.05.027. Epub 2017 May 28.
PubMed 28566221
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Lymph Node Mapping with Double Tracer and Double Injection Sites in Early-Stage Endometrium Cancer
- ClinicalTrials.gov ID
- NCT06163963
- Acronym / sponsor ID
- 2023/2015
- Conditions
- Sentinel Lymph Node, Endometrial Cancer
- Keywords
- double tracer, endometrial cancer, sentinel lymph node
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 11 Dec 2023 (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.
The aim of this prospective study is to investigate whether the detection rate of sentinel lymph node (SLN) with double tracer injected at two different sites may be increased compared to the standard use of a single tracer with single site (cervix) injection in early-stage endometrial cancer.
Detailed description
Endometrial cancer is the most common gynecologic cancer. Although 85-90% of women are diagnosed at early stage, about 10-15% are diagnosed at advanced stages. Treatment and prognosis depends on the surgical staging of the apparently early stage disease including the evaluation of lymphatic status of the disease. Detection of positive lymph node upstages the apparently early stage endometrial cancer. However, systematic lymphadenectomy carries immediate and long term risks for patients including bleeding, massive transfusions, prolongation of operation time, serious major vessel and major abdominal organ injury and death. These risks are especially increased in para-aortic lymphadenectomy which is a part of staging procedure in apparently early stage endometrial cancer.
Sentinel lymph node biopsy (SLNB) procedure is the biopsy of one or two lymph node(s) which represents the lymph node basin draining the area of malignancy. This biopsy may potentially eliminate the need systemic pelvic / para-aortic lymphadenectomy which harbours potential complications. Although SLNB became an standard procedure in endometrial cancer, available data on the SLNB in endometrial cancer is variable. The relevant literature suggests that the detection rate of sentinel lymph node using various tracer agents are between %70-98, even with lower for bilateral pelvic detection and para-aortic sentinel lymph node(s). The most commonly used tracer agents are methylene blue, radiolabeled colloid technetium 99 (Tc99), isosulfan blue and fluorescent indocyanine green. Although subserosal, intramyometrial uterine injections and peritumoral injections using hysteroscopy with different tracers and different detection rates have been used, cervical injection with ICG is the most favoured and standard technique with highest pelvic SLN detection rates. However, the para-aortic SLN detection rates are not satisfactory with a single tracer injected into cervix which may be critical especially in high grade endometrioid, serous and clear cell histological types.
So, investigators aimed to investigate whether the sentinel lymph node detection rates may be improved with double tracer injected at two different sites (charcoal carbon black dye injected in subserosa and ICG injected into cervix) compared to standard single tracer injected in early-stage endometrial cancer, especially the para-aortic sentinel lymph nodes. Sterile charcoal carbon black dye is an agent previously used for sentinel lymph node detection in various cancers such as breast cancer.
Technically, 2 mL indocyanine green with sterile water is injected at 3 and 9 o'clocks (each 1 mL) of cervix before the start of laparoscopic operation. Additionally, 2-4 mL of sterile charcoal carbon black dye is carefully injected just beneath the serosal layer at uterine fundus bilaterally avoiding intravascular injection This is done classically during laparoscopy by a spinal needle introduced under optical supervision after all optical and operative instruments are entered. 10-15 minute interval is allowed before the start of harvesting sentinel lymph nodes in pelvic and paraaortic region.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single arm interventional study aiming at the comparison of the effectiveness of detection for sentinel lymph node biopsy using double tracer compared to classic single tracer in early stage endometrial cancer. So, we aimed to investigate whether the sentinel lymph node detection rates may be improved with double tracer injected at two different sites (charcoal carbon black dye injected in subserosa and ICG injected into cervix) compared to standard single tracer injected in early-stage endometrial cancer, especially the para-aortic sentinel lymph nodes. Sterile charcoal carbon black dye is an agent previously used for sentinel lymph node detection in various cancers such as breast cancer. Sentinel lymph node detection rates of each region (pelvic, obturator, inframesenteric para-aortic, supra-mesenteric - infrarenal para-aortic), bilaterality/ unilaterality and staining with single or double tracer will be discussed compared to literature data.
| Arm | Type | Receives |
|---|---|---|
| Sentinel Lymph Node Mapping With Double Tracer in Endometrium Cancer (Single Arm) | Experimental | Diagnostic Test: Sentinel Lymph Node Mapping With Double Tracer and Double Injection Sites in Early-Stage Endometrium Cancer, Diagnostic Test: charcoal injection to uterus to map sentinel lymph nodesSentinel Lymph Node Mapping With Double Tracer and Double Injection Sites in Early-Stage Endometrium Cancer (Single Arm) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must have preoperative histologic diagnosis of endometrial carcinoma
- Must be in early stage ( stage1 and 2) endometrial carcinoma radiologically and clinically
- Must have written informed consent
Key exclusion criteria (3 listed)
- Possible allergic reaction to commonly used drugs
- Medical or surgical contraindications for comphrensive staging
- Preoperative or intraoperative findings of advanced endometrial cancer
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 |
|---|---|---|
| Sentinel Lymph Node Mapping With Double Tracer and Double Injection Sites in Early-Stage Endometrium CancerThis is a single arm interventional prospective study. Sentinel lymph node detection rate of the tracer injected in cervix (ICG- indocyanine green) before operation and the second tracer injected in uterine fundal subserosa (sterile charcoal black) at the start of operation are investigated. It is anticipated that additional tracer used in the uterine serosa may overcome the insufficiency (or increase the detection rate) of the standard single tracer injected in cervix for detection rate of sentinel lymph nodes, especially in paraaortic sentinel lymph nodes. | Diagnostic test | Sentinel Lymph Node Mapping With Double Tracer in Endometrium Cancer (Single Arm) |
| charcoal injection to uterus to map sentinel lymph nodesDuring surgery for endometrial cancer, charcoal injection to uterus to map sentinel lymph nodes in para aortic area besides the classic ınjection of indocyanine green for pelvic sentinel lymph node mapping. | Diagnostic test | Sentinel Lymph Node Mapping With Double Tracer in Endometrium Cancer (Single Arm) |
Primary outcome
Detection rate of sentinel lymph nodes with double tracer in early stage endometrial carcinoma
Time frame: From the day of surgery to final pathology report (2 weeks)
Detection rates of sentinel lymph nodes for both tracers in every pelvic and paraaortic lymph node basin are the primary outcome of the study.Sentinel lymph node detection rates of each region (pelvic, obturator, inframesenteric para-aortic, supra-mesenteric - infrarenal para-aortic), bilaterality/ unilaterality and staining with single or double tracer will be discussed compared to literature data.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Background: PubMed 35397864Crosbie EJ, Kitson SJ, McAlpine JN, Mukhopadhyay A, Powell ME, Singh N. Endometrial cancer. Lancet. 2022 Apr 9;399(10333):1412-1428. doi: 10.1016/S0140-6736(22)00323-3.
- Background: PubMed 25502426Cibula D, Oonk MH, Abu-Rustum NR. Sentinel lymph node biopsy in the management of gynecologic cancer. Curr Opin Obstet Gynecol. 2015 Feb;27(1):66-72. doi: 10.1097/GCO.0000000000000133.
- Background: PubMed 27941361Lee YC, Lheureux S, Oza AM. Treatment strategies for endometrial cancer: current practice and perspective. Curr Opin Obstet Gynecol. 2017 Feb;29(1):47-58. doi: 10.1097/GCO.0000000000000338.
- Background: PubMed 33082238van den Heerik ASVM, Horeweg N, de Boer SM, Bosse T, Creutzberg CL. Adjuvant therapy for endometrial cancer in the era of molecular classification: radiotherapy, chemoradiation and novel targets for therapy. Int J Gynecol Cancer. 2021 Apr;31(4):594-604. doi: 10.1136/ijgc-2020-001822. Epub 2020 Oct 20.
- Background: PubMed 28566221Holloway RW, Abu-Rustum NR, Backes FJ, Boggess JF, Gotlieb WH, Jeffrey Lowery W, Rossi EC, Tanner EJ, Wolsky RJ. Sentinel lymph node mapping and staging in endometrial cancer: A Society of Gynecologic Oncology literature review with consensus recommendations. Gynecol Oncol. 2017 Aug;146(2):405-415. doi: 10.1016/j.ygyno.2017.05.027. Epub 2017 May 28.
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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.
Samet TOPUZ, PROF. DR. study director
ISTANBUL UNİVERSİTY MED FAC DEPT. OF OBSTET AND GYNECOL. DIVISION OF GYNECOLOGİC ONCOLOGY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sentinel Lymph Node Mapping With Double Tracer and Double Injection Sites in Early-Stage Endometrium Cancer and charcoal injection to uterus to map sentinel lymph nodes in people with Sentinel Lymph Node and Endometrial Cancer, run by Istanbul University at 1 site in Turkey (Türkiye).
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 3 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 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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 Mustafa ALBAYRAK, MD (+905326871051, mustafaalbayrak@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of sentinel lymph nodes with double tracer in early stage endometrial carcinoma (time frame: From the day of surgery to final pathology report (2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06163963, which also lists 5 linked publications.
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 25 Nov 2024; AzTrials last refreshed its copy on 31 Oct 2026.