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| Trial Information |
Public title |
29/12/2025 |
As requested by the reviewer |
معدل الكشف عن العقد الليمفاوية الحارسة بواسطة خضرة الإندوسيانين في مريضات الدرجة المتوسطة والعالية من سرطان الرحم |
Detection rate of ICG SLN in intermediate and high grade endometrial cancer |
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Trial description |
29/12/2025 |
the reviewer asked for a brief background about the study |
This is a single center prospective cohort study, will be conducted on 39 patients with clinically node negative pathologically proven intermediate and high grade endometrial cancer. Our study aims to evaluate overall and bilateral detection rate of SLNB using ICG, so this will help to determine whether SLN biopsy, using ICG, could, in the future, replace systemic lymphadenectomy for surgical staging of intermediate and high grade endometrial cancer. |
This is a single center prospective cohort study, will be conducted on 39 patients with clinically node negative pathologically proven intermediate and high grade endometrial cancer. Our study aims to evaluate overall and bilateral detection rate of SLNB using ICG, so this will help to determine whether SLN biopsy, using ICG, could, in the future, replace systemic lymphadenectomy for surgical staging of intermediate and high grade endometrial cancer.
In this study, one 25 mg vial of ICG powder will be reconstituted in 10mL of sterile water (2.5mg/ mL) and drawn into a spinal needle. The cervix was injected at the 3- and 9-o'clock positions with 0.5 mL of IGC superficially (at 1- to 2-mm depth) and 0.5 mL of ICG deep (at 10-mm depth) for a total dose of 2 mL of ICG.
Patients will undergo a standard algorithm for SLNB. In the first step, each hemi-pelvis will be assessed for successful mapping of a SLN.
Surgeons will enter the retroperitoneum over the psoas muscle and identify lymph node channels and stations using the Karl Storz ENDOSKOPE ICG camera system with near-infrared spectroscopy (NIR) imaging. All green nodes and non-green nodes with green afferent lymphatic channels will be deemed SLN.
Surgeon should retrieve SLNs within 10 minutes after injection of ICG.
Then, SLN will be resected from mapped sides and will be send for paraffin, and locations will be noted by the surgeon on standardized intraoperative data collection forms.
Total laparoscopic hysterectomy and bilateral salpingo-oophorectomy will be done.
In the final step, patients will undergo standard lymphadenectomy bilateral pelvic only in intermediate grade and bilateral pelvic and paraaortic lymphadenectomy in high grade till inferior mesenteric artery.
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Trial description |
14/01/2026 |
as the reviewer asked to add brief background |
This is a single center prospective cohort study, will be conducted on 39 patients with clinically node negative pathologically proven intermediate and high grade endometrial cancer. Our study aims to evaluate overall and bilateral detection rate of SLNB using ICG, so this will help to determine whether SLN biopsy, using ICG, could, in the future, replace systemic lymphadenectomy for surgical staging of intermediate and high grade endometrial cancer.
In this study, one 25 mg vial of ICG powder will be reconstituted in 10mL of sterile water (2.5mg/ mL) and drawn into a spinal needle. The cervix was injected at the 3- and 9-o'clock positions with 0.5 mL of IGC superficially (at 1- to 2-mm depth) and 0.5 mL of ICG deep (at 10-mm depth) for a total dose of 2 mL of ICG.
Patients will undergo a standard algorithm for SLNB. In the first step, each hemi-pelvis will be assessed for successful mapping of a SLN.
Surgeons will enter the retroperitoneum over the psoas muscle and identify lymph node channels and stations using the Karl Storz ENDOSKOPE ICG camera system with near-infrared spectroscopy (NIR) imaging. All green nodes and non-green nodes with green afferent lymphatic channels will be deemed SLN.
Surgeon should retrieve SLNs within 10 minutes after injection of ICG.
Then, SLN will be resected from mapped sides and will be send for paraffin, and locations will be noted by the surgeon on standardized intraoperative data collection forms.
Total laparoscopic hysterectomy and bilateral salpingo-oophorectomy will be done.
In the final step, patients will undergo standard lymphadenectomy bilateral pelvic only in intermediate grade and bilateral pelvic and paraaortic lymphadenectomy in high grade till inferior mesenteric artery.
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This is a single center prospective cohort study, will be conducted on 39 patients with clinically node negative pathologically proven intermediate and high grade endometrial cancer. Our study aims to evaluate overall and bilateral detection rate of SLNB using ICG, so this will help to determine whether SLN biopsy, using ICG, could, in the future, replace systemic lymphadenectomy for surgical staging of intermediate and high grade endometrial cancer.
Back ground: Endometrial cancer (EC) is the most common gynecological malignancy of the female genital tract in developed countries. In terms of mortality of female genital tract cancers, the rate of EC is the second highest worldwide. High-grade EC include FIGO grade 3 endometrioid carcinomas, serous carcinomas, clear cell carcinomas, undifferentiated/dedifferentiated carcinomas, and carcinosarcoma. They metastasize via the lymphatic system. In contrast, low-grade type 1 endometrioid carcinomas tend to remain confined to the uterus. Lymph node (LN) metastasis is the primary route of metastasis of malignant uterine tumors as well as the main recurrence cause and the main risk factors of lymphatic involvement are myometrial involvement and histologic grade. Lymph node assessment as a staging procedure has been clinically important in evaluating the disease extent and providing prognostic information, which may help in deciding adjuvant treatments. Lymphadenectomy in high-grade EC histotypes, was associated with improved overall and recurrence free survival. Regarding extensive systemic lymphadenectomy, A study of the treatment of cancer of the womb (ASTEC) trial and the Italian collaborative trial reported a considerable increase in lymphatic dissection complications (relative risk [RR]: 3.73; 95% CI: 1.04−13.27) and surgical morbidity (RR: 8.39; 95% CI: 4.06−17.33). Although SLNB has gained acceptance in the context of low-grade EC, its role in high-grade EC remains unclear. Fluorescent dye Indocyanine green (ICG), a safe and effective agent for SLN mapping, has emerged as the most recommended tracer for intraoperative detection of SLN in EC owing to its higher sensitivity and specificity compared with conventional tracers (blue dye and radiotracer) |
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Updated Value
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| Trial Information |
Trial description |
22/01/2026 |
PACTR Admin |
This is a single center prospective cohort study, will be conducted on 39 patients with clinically node negative pathologically proven intermediate and high grade endometrial cancer. Our study aims to evaluate overall and bilateral detection rate of SLNB using ICG, so this will help to determine whether SLN biopsy, using ICG, could, in the future, replace systemic lymphadenectomy for surgical staging of intermediate and high grade endometrial cancer.
Back ground: Endometrial cancer (EC) is the most common gynecological malignancy of the female genital tract in developed countries. In terms of mortality of female genital tract cancers, the rate of EC is the second highest worldwide. High-grade EC include FIGO grade 3 endometrioid carcinomas, serous carcinomas, clear cell carcinomas, undifferentiated/dedifferentiated carcinomas, and carcinosarcoma. They metastasize via the lymphatic system. In contrast, low-grade type 1 endometrioid carcinomas tend to remain confined to the uterus. Lymph node (LN) metastasis is the primary route of metastasis of malignant uterine tumors as well as the main recurrence cause and the main risk factors of lymphatic involvement are myometrial involvement and histologic grade. Lymph node assessment as a staging procedure has been clinically important in evaluating the disease extent and providing prognostic information, which may help in deciding adjuvant treatments. Lymphadenectomy in high-grade EC histotypes, was associated with improved overall and recurrence free survival. Regarding extensive systemic lymphadenectomy, A study of the treatment of cancer of the womb (ASTEC) trial and the Italian collaborative trial reported a considerable increase in lymphatic dissection complications (relative risk [RR]: 3.73; 95% CI: 1.04−13.27) and surgical morbidity (RR: 8.39; 95% CI: 4.06−17.33). Although SLNB has gained acceptance in the context of low-grade EC, its role in high-grade EC remains unclear. Fluorescent dye Indocyanine green (ICG), a safe and effective agent for SLN mapping, has emerged as the most recommended tracer for intraoperative detection of SLN in EC owing to its higher sensitivity and specificity compared with conventional tracers (blue dye and radiotracer) |
Back ground: Endometrial cancer (EC) is the most common gynecological malignancy of the female genital tract in developed countries. In terms of mortality of female genital tract cancers, the rate of EC is the second highest worldwide. High-grade EC include FIGO grade 3 endometrioid carcinomas, serous carcinomas, clear cell carcinomas, undifferentiated/dedifferentiated carcinomas, and carcinosarcoma. They metastasize via the lymphatic system. In contrast, low-grade type 1 endometrioid carcinomas tend to remain confined to the uterus. Lymph node (LN) metastasis is the primary route of metastasis of malignant uterine tumors as well as the main recurrence cause and the main risk factors of lymphatic involvement are myometrial involvement and histologic grade. Lymph node assessment as a staging procedure has been clinically important in evaluating the disease extent and providing prognostic information, which may help in deciding adjuvant treatments. Lymphadenectomy in high-grade EC histotypes, was associated with improved overall and recurrence free survival. Regarding extensive systemic lymphadenectomy, A study of the treatment of cancer of the womb (ASTEC) trial and the Italian collaborative trial reported a considerable increase in lymphatic dissection complications (relative risk [RR]: 3.73; 95% CI: 1.04−13.27) and surgical morbidity (RR: 8.39; 95% CI: 4.06−17.33). Although SLNB has gained acceptance in the context of low-grade EC, its role in high-grade EC remains unclear. Fluorescent dye Indocyanine green (ICG), a safe and effective agent for SLN mapping, has emerged as the most recommended tracer for intraoperative detection of SLN in EC owing to its higher sensitivity and specificity compared with conventional tracers (blue dye and radiotracer).
This is a single center prospective cohort study, will be conducted on 39 patients with clinically node negative pathologically proven intermediate and high grade endometrial cancer. Our study aims to evaluate overall and bilateral detection rate of SLNB using ICG, so this will help to determine whether SLN biopsy, using ICG, could, in the future, replace systemic lymphadenectomy for surgical staging of intermediate and high grade endometrial cancer. |
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| Eligibility |
Age group |
29/12/2025 |
the reviewer asked to tick all applicable age group including the minimum age |
Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year |
Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year |
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| Outcome |
OutCome List |
29/12/2025 |
the reviewer to specify when outcomes will be measured |
Primary Outcome, Evaluation of overall and bilateral detection rate of SLNB using ICG, so this will help to determine whether SLN biopsy, using ICG, could, in the future, replace systemic lymphadenectomy for surgical staging of intermediate and high-grade endometrial cancer. this outcome will be measured post operative after paraffin result , both will be measured after paraffin result postoperatively |
Primary Outcome, Evaluation of overall and bilateral detection rate of SLNB using ICG, so this will help to determine whether SLN biopsy, using ICG, could, in the future, replace systemic lymphadenectomy for surgical staging of intermediate and high-grade endometrial cancer. this outcome will be measured post operative after paraffin result , both outcomes will be measured after paraffin result postoperatively |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Outcome |
OutCome List |
29/12/2025 |
the reviewer to specify when outcomes will be measured |
Primary Outcome, Evaluation of overall and bilateral detection rate of SLNB using ICG, so this will help to determine whether SLN biopsy, using ICG, could, in the future, replace systemic lymphadenectomy for surgical staging of intermediate and high grade endometrial cancer. , 1- Overall detection rate of ICG SLNB 2- Bilateral detection rate of ICG SLNB in patients with intermediate and high grade endometrial cancer |
Primary Outcome, Evaluation of overall and bilateral detection rate of SLNB using ICG, so this will help to determine whether SLN biopsy, using ICG, could, in the future, replace systemic lymphadenectomy for surgical staging of intermediate and high-grade endometrial cancer. this outcome will be measured post operative after paraffin result , 1- Overall detection rate of ICG SLNB 2- Bilateral detection rate of ICG SLNB in patients with intermediate and high grade endometrial cancer both will be measured after paraffin result postoperativ |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Outcome |
OutCome List |
29/12/2025 |
the reviewer to specify when outcomes will be measured |
Primary Outcome, Evaluation of overall and bilateral detection rate of SLNB using ICG, so this will help to determine whether SLN biopsy, using ICG, could, in the future, replace systemic lymphadenectomy for surgical staging of intermediate and high-grade endometrial cancer. this outcome will be measured post operative after paraffin result , 1- Overall detection rate of ICG SLNB 2- Bilateral detection rate of ICG SLNB in patients with intermediate and high grade endometrial cancer both will be measured after paraffin result postoperativ |
Primary Outcome, Evaluation of overall and bilateral detection rate of SLNB using ICG, so this will help to determine whether SLN biopsy, using ICG, could, in the future, replace systemic lymphadenectomy for surgical staging of intermediate and high-grade endometrial cancer. this outcome will be measured post operative after paraffin result , both will be measured after paraffin result postoperatively |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Outcome |
OutCome List |
29/12/2025 |
the reviewer asked to specify time when this outcome will be measured |
Secondary Outcome, Determine whether SLN biopsy, using ICG, could, in the future, replace systemic lymphadenectomy for surgical staging of intermediate and high grade endometrial cancer. , 1- If SLN biopsy, using ICG, could, in the future, replace systemic lymphadenectomy for surgical staging of intermediate and high grade endometrial cancer. |
Secondary Outcome, Determine whether SLN biopsy, using ICG, could, in the future, replace systemic lymphadenectomy for surgical staging of intermediate and high grade endometrial cancer. , At the end of the study when all data of the participant collected and statistically analysed |
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| Ethics |
Ethics List |
22/01/2026 |
The reviewer asked to clarify if the ethics approval for 1 year and i am planning to start in 2026, actually the ethics approval has no time limit as showed in attached IRB letter which i obtained in 2024, yet the study will start in 2026 for 2 years duration |
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TRUE, Medical Research Ethics Committee Institutional Review Board Mansoura Faculty of Medicine Mansoura University, Al Gomhorya street, Mansoura , 92361, Egypt, , 16 Sep 2024, +201092127930, IRB.MFM@hotmail.com, 39689_38040_4737.pdf |
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Date
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Old Value
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Updated Value
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| Ethics |
Ethics List |
22/01/2026 |
The reviewer asked to clarify if the ethics approval for 1 year and i am planning to start in 2026, actually the ethics approval has no time limit as showed in attached IRB letter which i obtained in 2024, yet the study will start in 2026 for 2 years duration |
TRUE, Medical Research Ethics Committee Institutional Review Board Mansoura Faculty of Medicine Mansoura University, Al Gomhorya street, Mansoura , 92361, Egypt, , 16 Sep 2024, +201092127930, IRB.MFM@hotmail.com, 39689_38040_4737.pdf |
TRUE, Medical Research Ethics Committee Institutional Review Board Mansoura Faculty of Medicine Mansoura University, Al Gomhorya street, Mansoura , 35516, Egypt, , 16 Sep 2024, +201092127930, IRB.MFM@hotmail.com, 39689_38040_4737.pdf |
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Ethics |
Ethics List |
18/02/2026 |
the reviewer asked for extension letter |
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TRUE, Medical Research Ethics Committee Institutional Review Board, AlGomhorya street, Mansoura, 35516, Egypt, , 01 Feb 2026, +20502202773, irb_staff@mans.edu.eg, 39689_38149_4737.pdf |
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| Funding Source |
FundingSources List |
29/12/2025 |
the reviewer asked for the actual name of funding sourse |
Self , Gehan Al sadat Street, Mansoura, , Egypt, Self Funded, |
Samar Abdallah , Gehan Al sadat Street, Mansoura, , Egypt, Self Funded, |