Uterine NeoplasmsNCT01564264
Sentinel Node Biopsy in Endometrial Cancer
A study testing Sentinel Lymph Node Biopsy in people with Uterine Neoplasms and Sentinel Lymph Node Biopsy, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
The purpose of this study is to determine if there is a difference between the lymphatic drainage of the cervix and corpus of the uterus after injecting a radiocolloid in the cervix and blue dye in the corpus of the uterus and to investigate the identification rate of sentinel nodes using this technique in patients… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Neoplasms, Sentinel Lymph Node Biopsy
- What is being tested?
- Sentinel Lymph Node Biopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2012to Dec 2014
- 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 older than 18 years old
- Endometrial cancer
- Histologies: Grade 2 and 3 endometrioid adenocarcinoma, clear cell and papillary serous carcinoma
- Suitable candidates for surgery
- Clinically stage 1 or confined to the uterus
Who cannot join
- Grade 1 endometrioid adenocarcinoma
- Metastatic disease
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Juravinski Hospital, Juravinski Cancer Centre, McMaster University
Hamilton, Ontario, L8V 5C2
Waldo G Jimenez, MD MSc, (905) 389-5688, Waldo.Jimenez@jcc.hhsc.ca
Laurie Elit, MD MSc, (905) 389-5688, Laurie.Elit@jcc.hhsc.ca
About this study
Official title: Prospective Cohort Study Evaluating Identification Rate of Sentinel Node in the Management of Endometrial Cancer Utilizing a Combined Method of Cervical and Myometrial Injections
The purpose of this study is to determine if there is a difference between the lymphatic drainage of the cervix and corpus of the uterus after injecting a radiocolloid in the cervix and blue dye in the corpus of the uterus and to investigate the identification rate of sentinel nodes using this technique in patients with cancer of the uterus.
Read the detailed description
About 20 percent of women diagnosed with uterine cancer have spread outside of the uterus, mainly to the lymph nodes. If these metastases are recognized these women can still be cured with chemotherapy and radiation. Unfortunately different kind of imaging are not very sensitive in identifying patients with lymph node metastases and currently a complete removal of the lymph nodes in the pelvis and around the aorta is the gold standard diagnostic test. Sentinel node biopsy (SLNB) is a surgical technique that aims to identify the nodes that drain specifically the area were the tumor is located. A tracer is injected around the tumor and then the locoregional lymph nodes are tested for the presence of this tracer (blue dye and a radioactive substance). If the sentinel lymph node does not contain cancer, then there is a high likelihood that the cancer has not spread to any other area of the body.The benefits of doing sentinel node biopsy is that it decreases the potential complications associated with the removal of all the lymph nodes. This technique is the standard treatment for other cancers as breast cancer and melanoma and is emerging as a promising technique in gynecological cancers.
There is no agreement regarding the best technique to do SLNB in women with uterine cancer and this procedure is still at the stage of determining feasibility. Since 1996, there have been publications aiming to determine the most appropriate way to do sentinel node in uterine cancer. As the uterus cannot be reached preoperatively for tracer injection, the standard approach for other tumor sites of preoperative peritumoral injection of Technetium 99 followed by intraoperative injection of blue dye has needed to be modified. Blue dye with or without a radiocolloid have been administered either subserously (the uterus outer layer), cervically, dually, and hysteroscopically with a wide range of results in terms of identification rates of sentinel nodes. Certain factors as site of injection, volume and number of injections, interval time since injection to identification of sentinel nodes and surgical approach as laparotomy versus laparoscopy have been associated with the likelihood of identifying these nodes.
This study plans to determine the pattern of lymphatic drainage for the cervix and corpus of the uterus by injecting a different tracer in these 2 sites and also to incorporate all factors that have been proved to be associated with a better identification rate of sentinel nodes in a protocol in order to determine if this technique is feasible and reliable.
- Conditions
- Uterine Neoplasms, Sentinel Lymph Node Biopsy
- Being tested
- Sentinel Lymph Node Biopsy
- Keywords
- Uterine Neoplasms, Sentinel Lymph Node Biopsy
- Medical subject headings
- Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel Lymph Node BiopsyProcedure or surgery
Sentinel node biopsy after injections of 0.4 mci of Technetium 99 in the cervix and 4 mL of Patent Blue into the myometrium followed by standard retroperitoneal lymph node dissection
| Study group | Role | What they receive |
|---|---|---|
| Sentinel Node Biopsy | Experimental | Each participant will have both measurements, the new diagnostic test (sentinel node biopsy) and the gold standard (complete lymphadenectomy) Receives: Procedure: Sentinel Lymph Node Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Location of Sentinel node
Locations: internal iliac, external iliac, common iliac, paraaortic or presacral areas Location will be registered by type of sentinel nodes: blue nodes, reflecting the uterine pattern of lymphatic flow (after myometrial injection of blue dye)and hot nodes, reflecting cervical pattern of lymphatic flow (after injection of Technetium 99 in the cervix)
Measured: Measurement for each participant will be performed between 2-4 hours after injecting Technetium 99 in the cervix
Secondary outcomes (1)
Identification of metastatic lymph nodes by the sentinel node procedure
Every participant will have a sentinel node procedure followed by a complete removal of the lymph nodes (gold standard), during the same surgery. Accuracy parameters of the sentinel node technique will be compared to the gold standard (complete lymphadenectomy)
Measured: Measurement will be performed 2-4 hours after the cervical injection with Technetium 99
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine NeoplasmsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Juravinski Cancer Centre Foundation
- Responsible party
- Sponsor
- Investigators
- Waldo G Jimenez, MD MSc, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564264
- Sponsor's protocol ID
- SNEndometrialCa
- Status last verified
- Aug 2014
- First submitted
- 23 Mar 2012
- Last updated
- 3 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study Evaluating Identification Rate of Sentinel Node in the Management of Endometrial Cancer Utilizing a Combined Method of Cervical and Myometrial Injections
- ClinicalTrials.gov ID
- NCT01564264
- Acronym / sponsor ID
- SNEndometrialCa
- Conditions
- Uterine Neoplasms, Sentinel Lymph Node Biopsy
- Keywords
- Uterine Neoplasms, Sentinel Lymph Node Biopsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Juravinski Cancer Centre Foundation
- Study start
- Nov 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 27 Mar 2012 (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 purpose of this study is to determine if there is a difference between the lymphatic drainage of the cervix and corpus of the uterus after injecting a radiocolloid in the cervix and blue dye in the corpus of the uterus and to investigate the identification rate of sentinel nodes using this technique in patients with cancer of the uterus.
Detailed description
About 20 percent of women diagnosed with uterine cancer have spread outside of the uterus, mainly to the lymph nodes. If these metastases are recognized these women can still be cured with chemotherapy and radiation. Unfortunately different kind of imaging are not very sensitive in identifying patients with lymph node metastases and currently a complete removal of the lymph nodes in the pelvis and around the aorta is the gold standard diagnostic test. Sentinel node biopsy (SLNB) is a surgical technique that aims to identify the nodes that drain specifically the area were the tumor is located. A tracer is injected around the tumor and then the locoregional lymph nodes are tested for the presence of this tracer (blue dye and a radioactive substance). If the sentinel lymph node does not contain cancer, then there is a high likelihood that the cancer has not spread to any other area of the body.The benefits of doing sentinel node biopsy is that it decreases the potential complications associated with the removal of all the lymph nodes. This technique is the standard treatment for other cancers as breast cancer and melanoma and is emerging as a promising technique in gynecological cancers.
There is no agreement regarding the best technique to do SLNB in women with uterine cancer and this procedure is still at the stage of determining feasibility. Since 1996, there have been publications aiming to determine the most appropriate way to do sentinel node in uterine cancer. As the uterus cannot be reached preoperatively for tracer injection, the standard approach for other tumor sites of preoperative peritumoral injection of Technetium 99 followed by intraoperative injection of blue dye has needed to be modified. Blue dye with or without a radiocolloid have been administered either subserously (the uterus outer layer), cervically, dually, and hysteroscopically with a wide range of results in terms of identification rates of sentinel nodes. Certain factors as site of injection, volume and number of injections, interval time since injection to identification of sentinel nodes and surgical approach as laparotomy versus laparoscopy have been associated with the likelihood of identifying these nodes.
This study plans to determine the pattern of lymphatic drainage for the cervix and corpus of the uterus by injecting a different tracer in these 2 sites and also to incorporate all factors that have been proved to be associated with a better identification rate of sentinel nodes in a protocol in order to determine if this technique is feasible and reliable.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sentinel Node Biopsy | Experimental | Procedure: Sentinel Lymph Node BiopsyEach participant will have both measurements, the new diagnostic test (sentinel node biopsy) and the gold standard (complete lymphadenectomy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women older than 18 years old
- Endometrial cancer
- Histologies: Grade 2 and 3 endometrioid adenocarcinoma, clear cell and papillary serous carcinoma
- Suitable candidates for surgery
- Clinically stage 1 or confined to the uterus
Key exclusion criteria (2 listed)
- Grade 1 endometrioid adenocarcinoma
- Metastatic disease
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 |
|---|---|---|
| Sentinel Lymph Node BiopsySentinel node biopsy after injections of 0.4 mci of Technetium 99 in the cervix and 4 mL of Patent Blue into the myometrium followed by standard retroperitoneal lymph node dissection | Procedure or surgery | Sentinel Node Biopsy |
Primary outcome
Location of Sentinel node
Time frame: Measurement for each participant will be performed between 2-4 hours after injecting Technetium 99 in the cervix
Locations: internal iliac, external iliac, common iliac, paraaortic or presacral areas Location will be registered by type of sentinel nodes: blue nodes, reflecting the uterine pattern of lymphatic flow (after myometrial injection of blue dye)and hot nodes, reflecting cervical pattern of lymphatic flow (after injection of Technetium 99 in the cervix)
1 secondary outcome
Identification of metastatic lymph nodes by the sentinel node procedure
Time frame: Measurement will be performed 2-4 hours after the cervical injection with Technetium 99
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2014.
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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.
Waldo G Jimenez, MD MSc principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sentinel Lymph Node Biopsy in people with Uterine Neoplasms and Sentinel Lymph Node Biopsy, run by Hamilton Health Sciences Corporation at 1 site 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 5 inclusion and 2 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 3 Sep 2014. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Waldo G Jimenez, MD MSc ((905) 389-5688, Waldo.Jimenez@jcc.hhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Location of Sentinel node (time frame: Measurement for each participant will be performed between 2-4 hours after injecting Technetium 99 in the cervix). 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 3 Sep 2014; AzTrials last refreshed its copy on 30 Oct 2026.