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
- 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 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;
Show all 10Show fewer
- 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.
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.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06656949
- Acronym / sponsor ID
- SLN-EC-01 / KYLL-202404-005-1
- Conditions
- Endometrial Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 30 Oct 2024 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 24 Oct 2024 (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 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study design is a two-arm, randomized, controlled trial.
| Arm | Type | Receives |
|---|---|---|
| sentinel lymph node mapping with One injection site (cervix) group | Active comparator | Procedure: injecting indocyanine green (ICG) dye Intraoperativeinjecting indocyanine green (ICG) dye Intraoperative in cervix |
| sentinel lymph node mapping with two injection site (cervix-uterus) group | Experimental | Procedure: injecting indocyanine green (ICG) dye Intraoperativeinjecting indocyanine green (ICG) dye Intraoperative in cervix and uterus |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • 1.Age >18 and <80 years old
Key exclusion criteria (10 listed)
- 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;
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 |
|---|---|---|
| injecting indocyanine green (ICG) dye Intraoperativeinjecting indocyanine green (ICG) dye Intraoperative for patients with endometrial cancer | Procedure or surgery | sentinel lymph node mapping with One injection site (cervix) group, sentinel lymph node mapping with two injection site (cervix-uterus) group |
Primary outcome
paraaortic Sentinel lymph node detection rates
Time frame: intraoperative day0
IGC positive Sentinel lymph node detection in paraaoritc lymph node will be assessed
Sentinel lymph node technique accuracy
Time frame: postoperative up to day7
Sensitivity and specificity measure of the sentinel lymph node for detecting the lymphatic metastasis
3 secondary outcomes
Optimizing Sentinel lymph node detection procedure in endometrium cancer
Time frame: intraoperative day 0
The difference Sentinel lymph node detection rate with Double Injection Sites and one injection site
Time frame: intraoperative day 0
Postoperative complications
Time frame: postoperative up to day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
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 4 inclusion and 10 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 24 Oct 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 China. 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 Jin Peng, PhD (86-18560088205, jin_peng@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
paraaortic Sentinel lymph node detection rates (time frame: intraoperative day0). The study lists 2 primary outcomes in all. 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 24 Oct 2024.