Endometrial CancerEndoSLNNCT01886066
Accuracy of Sentinel Lymph Node Biopsy in Nodal Staging of High Risk Endometrial Cancer
A study testing Indocyanine Green (ICG) in people with Endometrial Cancer and Sentinel Lymph Node, run by University Health Network, Toronto at 2 sites in Canada.
Trial summary
The standard of care for women with high risk endometrial cancer is the removal of all visible lymph nodes in the pelvis and lower abdomen to identify if disease has spread to these areas. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer, Sentinel Lymph Node, Indocyanine Green
- What is being tested?
- Indocyanine Green (ICG)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 2 sitesCanada
- Study dates
- Mar 2012to Sep 2021
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with endometrial cancer with high risk histologic subtypes including grade 3 endometrioid, carcinosarcoma, serous, clear cell, undifferentiated adenocarcinoma, and and any mixed high risk histology.
- Clinical stage 1 disease- no evidence of metastatic disease beyond the uterus by physical exam or preoperative imaging if performed.
- Patients who have signed an approved informed consent.
- Patients who will undergo surgery that includes a hysterectomy and bilateral pelvic and inframesenteric para-aortic lymphadenectomy via laparoscopy or robotic-assisted.
Who cannot join
- Women with grade 1 or 2 endometrioid adenocarcinoma
- Patients with evidence of metastatic disease on preoperative imaging.
- Patients with evidence of intraperitoneal metastatic disease intraoperatively (patients with suspicious retroperitoneal lymph nodes intraoperatively will still be included).
- Patients with known allergy to iodine compounds
- Pregnant patient.
- Patients with previous retroperitoneal surgery.
Show all 9Show fewer
- Patients with previous history of pelvic/abdominal radiation.
- Patients with recurrent endometrial cancer.
- Any patient treated with neoadjuvant chemotherapy and/or radiation.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Sunnybrook Health Sciences Center
Toronto, Ontario, M4N3M5
University Health Network - Princess Margaret Hospital
Toronto, Ontario, M5T 2M9
About this study
Official title: Accuracy of Sentinel Lymph Node Biopsy in Nodal Staging of High Risk Endometrial Cancer: A Prospective Trial
The standard of care for women with high risk endometrial cancer is the removal of all visible lymph nodes in the pelvis and lower abdomen to identify if disease has spread to these areas. It is estimated that no more than 25% of all women with presumed early stage high risk endometrial cancer will have positive lymph nodes however currently the majority of women are subjected to extensive resection of all pelvic lymph and or para-aortic lymph nodes and its associated morbidities. The objective of this study is to determine if intraoperative sentinel lymph node (SLN) mapping will improve the assessment of regional lymph nodes and enhance the detection of lymph nodes with metastatic disease in endometrial cancer. This would benefit the majority of women with early stage high risk endometrial cancer and would prevent the associated complications of pelvic lymph node dissection.
Read the detailed description
If the SLN can be accurately identified and the detection of metastatic lymph nodes in women with early stage high risk endometrial cancer can be improved then the majority of women could avoid a complete systematic pelvic lymphadenectomy. Pelvic lymphadenectomy is associated with many intraoperative and postoperative complications such as hemorrhage, lymphocyst formation, nerve injury and chronic lower extremity lymphedema. If less invasive techniques to assess regional lymph node involvement, such as SLN mapping, replaced routine pelvic lymphadenectomy the complications associated with more extensive pelvic surgery could be avoided.
This will be a prospective cohort study. The population to be studied will be patients with newly diagnosed early stage high risk endometrial cancer who will undergo primary surgical intervention that includes hysterectomy and bilateral pelvic and inframesenteric para-aortic lymphadenectomy via laparotomy, laparoscopy or robotic-assisted. Patients will be taken to the operating room for their planned procedure. After initiation of general anesthesia, fluorescent dye (indocyanine green, ICG) will be injected into the patient's cervix. The dye will be visualized by excitation with an infrared light (an attachment on the Novadaq Pinpoint system for laparoscopy). The surgery will proceed and all lymph nodes that are "green" will be removed surgically and their anatomic location and laterality documented. These "green" sentinel nodes will be assessed by a study pathologist by frozen section and the result read out intraoperatively. The hysterectomy and complete lymphadenectomy will then be performed. The SLN status will be compared to the status of the other nodes removed at complete lymphadenectomy. All data on these patients will be prospectively collected.
- Conditions
- Endometrial Cancer, Sentinel Lymph Node, Indocyanine Green
- Being tested
- Indocyanine Green (ICG)
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine Green (ICG)Biological
ICG (Indocyanine Green) will be used as a fluorescent agent to identify sentinel lymph nodes intraoperatively. One 25 mg vial of ICG will be reconstituted in 10 mL of aqueous solvent (2.5 mg/mL). The solution will be injected at the 3 and 9 o'clock positions of the cervical stroma. 0.5 mL is injected superficially (submucosa) and 0.5 mL is injected deep (~8mm) in the cervical stroma for a total injection volume of 2 mL.
| Study group | Role | What they receive |
|---|---|---|
| Indocyanine Green | Experimental | All patients on study will have ICG injection for SLN mapping Receives: Biological: Indocyanine Green (ICG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Analysis
Performance analyses of SLN mapping will be performed. In particular, sensitivity, specificity, and predictive accuracy of mapping and detection of sentinel lymph nodes with metastatic disease will be calculated using the pathology results of the surgical intervention as the Standard of Reference. Performance analyses will be evaluated at both the lesion and patient level. Generalized estimating equations will be used to adjust for correlations of repeated measures within patients. Raw performance estimates will be reported with adjusted 95% confidence intervals.
Measured: Year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startMar 2012
- Primary completion21 Jun 2019
- Study completionSep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is an Investigator-Initiated Prospective Trial (not a clinical trial, as ICG not a novel drug that is being used as intervention).
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Ferguson, MD, Principal investigator, The Princess Margaret Cancer Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886066
- Sponsor's protocol ID
- 12-0257-C
- Acronym
- EndoSLN
- Status last verified
- Mar 2024
- First submitted
- 20 Jun 2013
- Last updated
- 15 Mar 2024
- Results posted
- No
Publications
Marchocki Z, Cusimano MC, Vicus D, Pulman K, Rouzbahman M, Mirkovic J, Cesari M, Maganti M, Zia A, Ene G, Ferguson SE. Diagnostic accuracy of frozen section and patterns of nodal spread in high grade endometrial cancer: A secondary outcome of the SENTOR prospective cohort study. Gynecol Oncol. 2023 Jun;173:41-48. doi: 10.1016/j.ygyno.2023.04.004. Epub 2023 Apr 18.
PubMed 37075495
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Sentinel Lymph Node Biopsy in Nodal Staging of High Risk Endometrial Cancer: A Prospective Trial
- ClinicalTrials.gov ID
- NCT01886066
- Acronym / sponsor ID
- EndoSLN / 12-0257-C
- Conditions
- Endometrial Cancer, Sentinel Lymph Node, Indocyanine Green
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- 21 Jun 2019 (actual)
- Study completion
- Sep 2021 (actual)
- First posted
- 25 Jun 2013 (estimated)
- 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 standard of care for women with high risk endometrial cancer is the removal of all visible lymph nodes in the pelvis and lower abdomen to identify if disease has spread to these areas. It is estimated that no more than 25% of all women with presumed early stage high risk endometrial cancer will have positive lymph nodes however currently the majority of women are subjected to extensive resection of all pelvic lymph and or para-aortic lymph nodes and its associated morbidities. The objective of this study is to determine if intraoperative sentinel lymph node (SLN) mapping will improve the assessment of regional lymph nodes and enhance the detection of lymph nodes with metastatic disease in endometrial cancer. This would benefit the majority of women with early stage high risk endometrial cancer and would prevent the associated complications of pelvic lymph node dissection.
Detailed description
If the SLN can be accurately identified and the detection of metastatic lymph nodes in women with early stage high risk endometrial cancer can be improved then the majority of women could avoid a complete systematic pelvic lymphadenectomy. Pelvic lymphadenectomy is associated with many intraoperative and postoperative complications such as hemorrhage, lymphocyst formation, nerve injury and chronic lower extremity lymphedema. If less invasive techniques to assess regional lymph node involvement, such as SLN mapping, replaced routine pelvic lymphadenectomy the complications associated with more extensive pelvic surgery could be avoided.
This will be a prospective cohort study. The population to be studied will be patients with newly diagnosed early stage high risk endometrial cancer who will undergo primary surgical intervention that includes hysterectomy and bilateral pelvic and inframesenteric para-aortic lymphadenectomy via laparotomy, laparoscopy or robotic-assisted. Patients will be taken to the operating room for their planned procedure. After initiation of general anesthesia, fluorescent dye (indocyanine green, ICG) will be injected into the patient's cervix. The dye will be visualized by excitation with an infrared light (an attachment on the Novadaq Pinpoint system for laparoscopy). The surgery will proceed and all lymph nodes that are "green" will be removed surgically and their anatomic location and laterality documented. These "green" sentinel nodes will be assessed by a study pathologist by frozen section and the result read out intraoperatively. The hysterectomy and complete lymphadenectomy will then be performed. The SLN status will be compared to the status of the other nodes removed at complete lymphadenectomy. All data on these patients will be prospectively collected.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an Investigator-Initiated Prospective Trial (not a clinical trial, as ICG not a novel drug that is being used as intervention).
| Arm | Type | Receives |
|---|---|---|
| Indocyanine Green | Experimental | Biological: Indocyanine Green (ICG)All patients on study will have ICG injection for SLN mapping |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women with endometrial cancer with high risk histologic subtypes including grade 3 endometrioid, carcinosarcoma, serous, clear cell, undifferentiated adenocarcinoma, and and any mixed high risk histology.
- Clinical stage 1 disease- no evidence of metastatic disease beyond the uterus by physical exam or preoperative imaging if performed.
- Patients who have signed an approved informed consent.
- Patients who will undergo surgery that includes a hysterectomy and bilateral pelvic and inframesenteric para-aortic lymphadenectomy via laparoscopy or robotic-assisted.
Key exclusion criteria (9 listed)
- Women with grade 1 or 2 endometrioid adenocarcinoma
- Patients with evidence of metastatic disease on preoperative imaging.
- Patients with evidence of intraperitoneal metastatic disease intraoperatively (patients with suspicious retroperitoneal lymph nodes intraoperatively will still be included).
- Patients with known allergy to iodine compounds
- Pregnant patient.
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 |
|---|---|---|
| Indocyanine Green (ICG)ICG (Indocyanine Green) will be used as a fluorescent agent to identify sentinel lymph nodes intraoperatively. One 25 mg vial of ICG will be reconstituted in 10 mL of aqueous solvent (2.5 mg/mL). The solution will be injected at the 3 and 9 o'clock positions of the cervical stroma. 0.5 mL is injected superficially (submucosa) and 0.5 mL is injected deep (~8mm) in the cervical stroma for a total injection volume of 2 mL. | Biological | Indocyanine Green |
Primary outcome
Performance Analysis
Time frame: Year 3
Performance analyses of SLN mapping will be performed. In particular, sensitivity, specificity, and predictive accuracy of mapping and detection of sentinel lymph nodes with metastatic disease will be calculated using the pathology results of the surgical intervention as the Standard of Reference. Performance analyses will be evaluated at both the lesion and patient level. Generalized estimating equations will be used to adjust for correlations of repeated measures within patients. Raw performance estimates will be reported with adjusted 95% confidence intervals.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Derived from this study: PubMed 37075495Marchocki Z, Cusimano MC, Vicus D, Pulman K, Rouzbahman M, Mirkovic J, Cesari M, Maganti M, Zia A, Ene G, Ferguson SE. Diagnostic accuracy of frozen section and patterns of nodal spread in high grade endometrial cancer: A secondary outcome of the SENTOR prospective cohort study. Gynecol Oncol. 2023 Jun;173:41-48. doi: 10.1016/j.ygyno.2023.04.004. Epub 2023 Apr 18.
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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.
Sarah Ferguson, MD principal investigator
The Princess Margaret Cancer Foundation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indocyanine Green (ICG) in people with Endometrial Cancer and Sentinel Lymph Node, run by University Health Network, Toronto at 2 sites in Canada.
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 9 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: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance Analysis (time frame: Year 3). 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 NCT01886066, which also lists 1 linked publication.
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 15 Mar 2024.