Ignite Creation Date:
2024-05-06 @ 3:15 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04577950
Status:
RECRUITING
Last Update Posted:
2021-01-27
First Post:
2020-09-12
Brief Title:
A Prospective Study Comparing Three Injection Sites to Detect Sentinel Lymph Nodes in Endometrial Cancer
Sponsor:
Centre Hospitalier Universitaire Vaudois
Organization:
Centre Hospitalier Universitaire Vaudois
Study Overview
Official Title:
A Prospective Phase 2 Study Comparing Three Injection Sites to Detect Sentinel Lymph Nodes in Endometrial Cancer Comparison of Lymphatic Drainages and Location of the Sentinel Lymph Nodes Depending on the Injection Site of the Tracer
Status:
RECRUITING
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SENNAN
Brief Summary:
Uterine cancer is the most common gynecologic malignancy in developed countries Adenocarcinoma of the endometrium is the most common histologic type of uterine cancer Endometrial cancer is the fifth most frequent cancer in women in Switzerland The incidence rose up to 59 in 2015 This tumor affects mainly older women at 63 years on average The majority of women are diagnosed at an early stage Seventy-five to 90 of the patients are alerted by abnormal uterine bleeding very quickly which allows a quick management of care and a high survival rate
Besides age one of the main risk factor of developing an endometrial carcinoma is obesity In fact obese women have higher risk to have an endometrial cancer but also at a younger age than the average and finally they have an increased risk of death due to this particular cancer Although this cancer is linked to the co-morbidities that go with obesity like diabetes or hypertension
The treatment of endometrial cancer in most women is surgery involving a total hysterectomy and a bilateral salpingo-oophorectomy with or without a lymph node dissection For patients with early stage endometrial cancer there is a disagreement regarding lymph nodes dissection because randomized controlled trials and a meta-analysis have shown no clear evidence on overall or recurrence-free survival and a higher incidence on early and late complications in relation with pelvic lymph node dissection A systematic lymph node dissection consists of removing all the nodes within a nodal drainage basin This dissection proves to be very difficult in obese patient and includes a risk to damage blood vessels or nerves Moreover lymph node dissection is associated with a higher morbidity longer operating time more frequent blood loss and finally symptomatic lymphedema and seroma
That is why sentinel lymph node biopsy SLNB seems to be a good alternative to lymph node dissection The tumors spread is assessed in lymph nodes with a reduced morbidity In fact lymphadenectomy and its dangerous complications like lymphedema could be avoided in the vast majority of cases Indeed a histological analysis of these sentinel lymph-nodes SLNs leads to ultrastadification cancers are graded depending on the presence and the size of metastasis in lymph nodes Adjuvant treatments such as radiotherapy or chemotherapy can be suggested following these data and a better management of endometrial cancer is possible
Besides age one of the main risk factor of developing an endometrial carcinoma is obesity In fact obese women have higher risk to have an endometrial cancer but also at a younger age than the average and finally they have an increased risk of death due to this particular cancer Although this cancer is linked to the co-morbidities that go with obesity like diabetes or hypertension
The treatment of endometrial cancer in most women is surgery involving a total hysterectomy and a bilateral salpingo-oophorectomy with or without a lymph node dissection For patients with early stage endometrial cancer there is a disagreement regarding lymph nodes dissection because randomized controlled trials and a meta-analysis have shown no clear evidence on overall or recurrence-free survival and a higher incidence on early and late complications in relation with pelvic lymph node dissection A systematic lymph node dissection consists of removing all the nodes within a nodal drainage basin This dissection proves to be very difficult in obese patient and includes a risk to damage blood vessels or nerves Moreover lymph node dissection is associated with a higher morbidity longer operating time more frequent blood loss and finally symptomatic lymphedema and seroma
That is why sentinel lymph node biopsy SLNB seems to be a good alternative to lymph node dissection The tumors spread is assessed in lymph nodes with a reduced morbidity In fact lymphadenectomy and its dangerous complications like lymphedema could be avoided in the vast majority of cases Indeed a histological analysis of these sentinel lymph-nodes SLNs leads to ultrastadification cancers are graded depending on the presence and the size of metastasis in lymph nodes Adjuvant treatments such as radiotherapy or chemotherapy can be suggested following these data and a better management of endometrial cancer is possible
Detailed Description:
Worldwide in 2012 527600 women were diagnosed with uterine cancer It is the most common gynecologic malignancy in developed countries In developing countries it is the second most common just behind cervical cancer Adenocarcinoma of the endometrium is the most common histologic site and type of uterine cancer Endometrial cancer is the fifth most frequent cancer in women in Switzerland The incidence rose up to 59 in 2015 This tumor affects mainly older women at 63 years on average The majority of women are diagnosed at an early stage confined to primary site for 67 spread to regional organs and lymph nodes for 21 and with distant metastasis for 8 Seventy-five to 90 of the patients are alerted by abnormal uterine bleeding very quickly which allows a quick management of care and a high survival rate
Besides age one of the main risk factor of developing an endometrial carcinoma is obesity In fact obese women have higher risk to have an endometrial cancer but also at a younger age than the average and finally they have an increased risk of death due to this particular cancer Although the investigators are not sure of the reasons it may be linked to the co-morbidities that go with obesity like diabetes or hypertension
The treatment of endometrial cancer in most women is surgery involving a total hysterectomy and a bilateral salpingo-oophorectomy with or without a lymph node dissection For patients with early stage endometrial cancer there is a disagreement among cancer centers regarding lymph nodes dissection because randomized controlled trials and a meta-analysis have shown no clear evidence on overall or recurrence-free survival and a higher incidence on early and late complications in relation with pelvic lymph node dissection A systematic lymph node dissection consists of removing all the nodes within a nodal drainage basin irrespective of size The problem with that technique is that dissection proves to be very difficult in obese patient and includes a risk to damage blood vessels or nervesMoreover lymph node dissection is associated with a higher morbidity longer operating time more frequent blood loss and finally symptomatic lymphedema and seroma Indeed the risk of leg lymphedema due to a node dissection is often under-reported with rates going from 5 to 38
That is why sentinel lymph node biopsy SLNB seems to many authors to be a good alternative to lymph node dissection The tumors spread is assessed in lymph nodes with a reduced morbidity In fact lymphadenectomy and its dangerous complications like lymphedema could be avoided in the vast majority of cases In cutaneous melanoma or in breasts cancer this technique is already widely used throughout the world A sentinel node is the first node involved in the movement of the tumor from the primary cancer to the lymph nodes When tumor cells spread to lymphatic network they arrive in the first place in that sentinel node If it contains no metastasis then nodes on the lymph path below will not be affected either
Not only SLNB in endometrial cancer is associated with a reduction in morbidity compared to lymph node dissection but with it a personalized treatment can be developed Indeed a histological analysis of these sentinel lymph-nodes SLNs leads to ultrastadification cancers are graded depending on the presence and the size of metastasis in lymph nodes Adjuvant treatments such as radiotherapy or chemotherapy can be suggested following these data and a better management of endometrial cancer is possible Now when lymph-node status is still unknown indication for adjuvant therapies are based on pathological features of surgical specimens of the tumor exposing some patients to either overtreatment or undertreatment
In fact five-year disease free survival in stage I patients with positive SLNs is 54 whereas survival with negative SLNs is up to 90Therefore SLN is one of the most important prognostic factors in endometrial cancer
Primary objective of SENNAN study The study seeks primarily to compare the location of uterine SLNs depending on the injection sites of the tracers whether in endometrium in uterine isthmus or in the cervix
Secondary objectives are
1 A comparison of the sensitivity of the tracers to detect SLNs
2 A description of the incidence of adverse events
3 An evaluation of additional time required to identify SLNs with or without lymph node dissection
4 A description of morbidity directly induced by the search of SLNs
5 A calculation of negative predictive value of the different markers and their associations
6 A correlation between the anatomical locations of the SLNs and ultrastadification of SLNs
7 An evaluation of the data of the lymphatic drainage depending on tumor location in the uterus
8 An evaluation of the data of the lymphatic drainage depending on histological grade of the tumor
9 An analysis of cases wherein change in the treatment have been made related to results of detection of SLNs
Procedure
The patients will have the day before the surgery an identification of the sentinel nodes with radiocolloid Nanocoll The marker at a radioactivity of 80 MBq will be injected in four points in the cervix 02 ml of 20 millibecquerel each A CTscintigraphy will be performed three or four hours after the injection The day of the surgery the patients will undergo a general anaesthesia and then under general anaesthesia the first step of the surgery will be to do the injection of the other two markers
ICG will be injected through hysteroscopic guidance apart of the tumoral lesions at 4 points of injections The volume of injected ICG will be 05 ml at each injection at the concentration of 5 mgml A total of 2 ml 10mg of ICG will be used
Patent blue will be diluted with 2 ml of physiologic serum Then it will be injected through the cervix along the uterus isthmus at the 3 oclock and 9 oclock level 2 ml will be injected on each side
Then the patients will have a laparoscopic surgical approach with identification of the sentinel nodes in the pelvic and lower abdomen areas After identification of all the sentinel nodes blue and or radioactive and or fluorescent nodes the patients will have a total hysterectomy with bilateral oophorectomy and salpingectomy The surgical technique for this procedure is the same as the one usually performed for this kind of lesions
The major benefit of looking for SLNs in endometrial cancer is that lymphadenectomy can be avoided for patients who have already comorbidities Indeed endometrial cancer is found in aged women and obese women are also more affected Lymphadenectomy is a heavy procedure with a risk of lymphedema That is why the technique of SLNs offers a good alternative with lesser surgical risks
Besides age one of the main risk factor of developing an endometrial carcinoma is obesity In fact obese women have higher risk to have an endometrial cancer but also at a younger age than the average and finally they have an increased risk of death due to this particular cancer Although the investigators are not sure of the reasons it may be linked to the co-morbidities that go with obesity like diabetes or hypertension
The treatment of endometrial cancer in most women is surgery involving a total hysterectomy and a bilateral salpingo-oophorectomy with or without a lymph node dissection For patients with early stage endometrial cancer there is a disagreement among cancer centers regarding lymph nodes dissection because randomized controlled trials and a meta-analysis have shown no clear evidence on overall or recurrence-free survival and a higher incidence on early and late complications in relation with pelvic lymph node dissection A systematic lymph node dissection consists of removing all the nodes within a nodal drainage basin irrespective of size The problem with that technique is that dissection proves to be very difficult in obese patient and includes a risk to damage blood vessels or nervesMoreover lymph node dissection is associated with a higher morbidity longer operating time more frequent blood loss and finally symptomatic lymphedema and seroma Indeed the risk of leg lymphedema due to a node dissection is often under-reported with rates going from 5 to 38
That is why sentinel lymph node biopsy SLNB seems to many authors to be a good alternative to lymph node dissection The tumors spread is assessed in lymph nodes with a reduced morbidity In fact lymphadenectomy and its dangerous complications like lymphedema could be avoided in the vast majority of cases In cutaneous melanoma or in breasts cancer this technique is already widely used throughout the world A sentinel node is the first node involved in the movement of the tumor from the primary cancer to the lymph nodes When tumor cells spread to lymphatic network they arrive in the first place in that sentinel node If it contains no metastasis then nodes on the lymph path below will not be affected either
Not only SLNB in endometrial cancer is associated with a reduction in morbidity compared to lymph node dissection but with it a personalized treatment can be developed Indeed a histological analysis of these sentinel lymph-nodes SLNs leads to ultrastadification cancers are graded depending on the presence and the size of metastasis in lymph nodes Adjuvant treatments such as radiotherapy or chemotherapy can be suggested following these data and a better management of endometrial cancer is possible Now when lymph-node status is still unknown indication for adjuvant therapies are based on pathological features of surgical specimens of the tumor exposing some patients to either overtreatment or undertreatment
In fact five-year disease free survival in stage I patients with positive SLNs is 54 whereas survival with negative SLNs is up to 90Therefore SLN is one of the most important prognostic factors in endometrial cancer
Primary objective of SENNAN study The study seeks primarily to compare the location of uterine SLNs depending on the injection sites of the tracers whether in endometrium in uterine isthmus or in the cervix
Secondary objectives are
1 A comparison of the sensitivity of the tracers to detect SLNs
2 A description of the incidence of adverse events
3 An evaluation of additional time required to identify SLNs with or without lymph node dissection
4 A description of morbidity directly induced by the search of SLNs
5 A calculation of negative predictive value of the different markers and their associations
6 A correlation between the anatomical locations of the SLNs and ultrastadification of SLNs
7 An evaluation of the data of the lymphatic drainage depending on tumor location in the uterus
8 An evaluation of the data of the lymphatic drainage depending on histological grade of the tumor
9 An analysis of cases wherein change in the treatment have been made related to results of detection of SLNs
Procedure
The patients will have the day before the surgery an identification of the sentinel nodes with radiocolloid Nanocoll The marker at a radioactivity of 80 MBq will be injected in four points in the cervix 02 ml of 20 millibecquerel each A CTscintigraphy will be performed three or four hours after the injection The day of the surgery the patients will undergo a general anaesthesia and then under general anaesthesia the first step of the surgery will be to do the injection of the other two markers
ICG will be injected through hysteroscopic guidance apart of the tumoral lesions at 4 points of injections The volume of injected ICG will be 05 ml at each injection at the concentration of 5 mgml A total of 2 ml 10mg of ICG will be used
Patent blue will be diluted with 2 ml of physiologic serum Then it will be injected through the cervix along the uterus isthmus at the 3 oclock and 9 oclock level 2 ml will be injected on each side
Then the patients will have a laparoscopic surgical approach with identification of the sentinel nodes in the pelvic and lower abdomen areas After identification of all the sentinel nodes blue and or radioactive and or fluorescent nodes the patients will have a total hysterectomy with bilateral oophorectomy and salpingectomy The surgical technique for this procedure is the same as the one usually performed for this kind of lesions
The major benefit of looking for SLNs in endometrial cancer is that lymphadenectomy can be avoided for patients who have already comorbidities Indeed endometrial cancer is found in aged women and obese women are also more affected Lymphadenectomy is a heavy procedure with a risk of lymphedema That is why the technique of SLNs offers a good alternative with lesser surgical risks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None