Endometrial CancerSLN-EC-01NCT06656949
Sentinel Lymph Node Mapping With Different Injection Sites of ICG in Endometrium Cancer
A study testing injecting indocyanine green (ICG) dye Intraoperative in people with Endometrial Cancer, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
The primary goal of this prospective study is to define the efficacy of the sentinel lymph node biopsy (SLNB) procedure by comparing different method performed in patients with endometrial cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- injecting indocyanine green (ICG) dye Intraoperative
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2024to 30 Jan 2026
- Phase
- Interventional
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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 1.Age >18 and <80 years old
- 2. The pathological diagnosis was epithelial ovarian cancer
- 3.Survival time is expected to exceed 3 months
- 4.Signed consent form
Who cannot join
- 1. Patients with myocardial infarction or stroke, or unstable angina pectoris or decompensated heart function
- 2.Patients with a history of exhaustion or deep vein thrombosis;
- 3. Liver insufficiency (transaminase >2.5 times the upper limit of the standard);
- 4. Renal insufficiency (serum muscle liver >2 times the standard upper limit);
- 5. Pregnancy and perinatal patients;
- 6. History of major organ transplantation and immune disease;
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- 7. Psychiatric condition or language barriers
- 8. Alcohol or drug abuser (current or previous)
- 9. Unable or unwilling to sign informed consent or comply with study requirements;
- 10. Patients with other malignant tumors.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital，Shandong University
Jinan, Shandong, 250012
Jin Peng, PhD, 86-18560088205, jin_peng@outlook.com
About this study
Official title: A Prospective, Randomized Trial Comparing the Different Injection Sites of Indocyanine Green (ICG) in Sentinel Lymph Node Mapping in Patients With Endometrial Cancer
The primary goal of this prospective study is to define the efficacy of the sentinel lymph node biopsy (SLNB) procedure by comparing different method performed in patients with endometrial cancer. The aim of this study is to investigate whether the detection rate of sentinel lymph node (SLN) with two different injection sites may be increased compared to the standard use with single site (cervix) injection in endometrial cancer.
Read the detailed description
The primary treatment for endometrial cancer involves total hysterectomy and bilateral salpingo-oophorectomy, with adjuvant radiotherapy and/or chemotherapy reserved for patients with advanced disease or who have risk factors for relapse. The tumor is confined to the uterus in 85% of endometrial cancers. Hence, it's controversial to perform systematic lymphadenectomy to all patients. The primary purpose of the present study is the to investigate the feasibility of sentinel lymph node determination in endometrial cancer patients operated via conventional laparoscopy. To determine sentinel lymph nodes cervical indocyanine green will be injected prior to the surgery. During the surgery using fluorescent imaging systems sentinel lymph nodes will be removed and examined by frozen section. Afterwards, systematic pelvic lymphadenectomy will be performed if sentinel lymph node is positive.
- Conditions
- Endometrial Cancer
- Being tested
- injecting indocyanine green (ICG) dye Intraoperative
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injecting indocyanine green (ICG) dye IntraoperativeProcedure or surgery
injecting indocyanine green (ICG) dye Intraoperative for patients with endometrial cancer
| Study group | Role | What they receive |
|---|---|---|
| sentinel lymph node mapping with One injection site (cervix) group | Active comparator | injecting indocyanine green (ICG) dye Intraoperative in cervix Receives: Procedure: injecting indocyanine green (ICG) dye Intraoperative |
| sentinel lymph node mapping with two injection site (cervix-uterus) group | Experimental | injecting indocyanine green (ICG) dye Intraoperative in cervix and uterus Receives: Procedure: injecting indocyanine green (ICG) dye Intraoperative |
What is being measured
The primary outcome is the main question the study is designed to answer.
paraaortic Sentinel lymph node detection rates
IGC positive Sentinel lymph node detection in paraaoritc lymph node will be assessed
Measured: intraoperative day0
Sentinel lymph node technique accuracy
Sensitivity and specificity measure of the sentinel lymph node for detecting the lymphatic metastasis
Measured: postoperative up to day7
Secondary outcomes (3)
Optimizing Sentinel lymph node detection procedure in endometrium cancer
Optimizing injectiong site, tow site injection vs one site injection
Measured: intraoperative day 0
The difference Sentinel lymph node detection rate with Double Injection Sites and one injection site
assessing difference IGC positive sentinel lymph node detection rate with Double Injection Sites and one injection site
Measured: intraoperative day 0
Postoperative complications
Postoperative complications including damage of insestine , urethra and bladder
Measured: postoperative up to day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start30 Oct 2024 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Jan 2026 (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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design is a two-arm, randomized, controlled trial.
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youzhong Zhang, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656949
- Sponsor's protocol ID
- KYLL-202404-005-1
- Acronym
- SLN-EC-01
- Status last verified
- Oct 2024
- First submitted
- 8 Oct 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No