Cervical CancerNCT02543775
Sentinel Lymph Node Detection in Early Cervical Cancer
A study testing Preoperative and intraoperative SLN Mapping in people with Cervical Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The primary objective of this study is to determine the feasibility of detecting the sentinel lymph node (SLN) in patients with early invasive cervical cancer using a combined radioisotope and blue dye technique. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Preoperative and intraoperative SLN Mapping
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2010to Feb 2017
- 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
- Women with invasive adenocarcinoma or squamous cell carcinoma of the cervix
- Stages 1A1 (+LVSI), 1A2 and 1B1 (< 4 cm)
- If CT, MRI or PET have been performed preoperatively there must be no clear evidence of metastatic disease and/or parametrial involvement.
- Patients who have signed an approved informed consent.
- Patients who will undergo surgery that includes a radical hysterectomy and/or radical trachelectomy and bilateral lymphadenectomy via laparotomy, laparoscopy or robotic-assisted.
Who cannot join
- Patients with known allergy to triphenylmethane compounds
- Pregnant patient
- Patients with previous retroperitoneal surgery
- Patients with previous history of pelvic/abdominal radiation
- Patients with recurrent cervical cancer
- Any patient treated with neoadjuvant chemotherapy and/or radiation
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to determine the feasibility of detecting the sentinel lymph node (SLN) in patients with early invasive cervical cancer using a combined radioisotope and blue dye technique.
The investigators hypothesize that the sentinel lymph node (first node draining the tumour/cervix) for early stage cervical cancer represents the status of the regional lymph node basin (pelvic lymph nodes) and identification of a negative SLN would negate the need for complete pelvic lymphadenectomy.
Read the detailed description
Cancers of the cervix that are small and appear to be contained in the cervix (early stage) have up to 20 percent chance of having pelvic lymph nodes involved. The standard therapy is removal of the uterus and cervix (radical hysterectomy) and removal of all pelvic lymph nodes for all women with early stage cervical cancer. This procedure can be associated with significant intraoperative and postoperative complications including increased risk of damage to blood vessels and nerves in the pelvic region (leading to bladder, bowel and sexual dysfunction) as well as lymphedema (swelling, particularly in the legs) associated with significant pelvic lymph tissue removal.
The objective of this study is to find a way to accurately identify the first lymph node that drains the tumour/cervix (SLN). If this SLN is correctly identified, and it's status (positive or negative for malignancy) is representative of the entire lymph node basin, a complete node dissection could be avoided. This could benefit many women with early stage cervical cancer, as a minority actually have evidence of disease in the nodes after surgery (between 5-20%) and limited lymph node sampling could prevent the associated complications of a full pelvic lymph node dissection.
This is a prospective cohort study. The population to be studied is patients with newly diagnosed early stage cervical cancer undergoing primary surgical intervention including radical hysterectomy and bilateral pelvic lymphadenectomy. On the morning of surgery, preoperative injection of a radiolabeled colloid will be performed in the Nuclear Medicine Department followed by SPECT/CT to visualize the radiolabelled dye. Patients will then be taken to the operating room for their planned procedure. After initiation of general anesthesia, blue dye will be injected into the patient's cervix. The surgery will proceed and all lymph nodes that are "blue" and/or "hot" will be removed surgically, their anatomic location and laterality documented and sent for frozen section intraoperatively. The radical hysterectomy or radical trachelectomy and complete systematic bilateral pelvic lymphadenectomy will then be performed. The SLN status reported by the pathologist based on the frozen section will be compared to the status of the other nodes removed after complete lymphadenectomy and reported in the final pathology report (after formalin fixation and paraffin embedding). All data on these patients will be prospectively collected.
This protocol will determine the feasibility of SLN mapping in women with early stage cervical cancer. The primary outcomes will be to measure the rate of detection of SLN using the combination of radiolabelled and blue dye (unilateral and bilateral detection rates will be reported) as well as the sensitivity and specificity of this technique, based on assessing how well the intraoperative reading of SLN frozen section corresponds with the final pathology lymph node status after examining all lymph nodes removed by complete pelvic lymphadenectomy.
In addition, the investigators will assess the usefulness of preoperative SPECT/CT in identifying SLN and whether this modality accurately identifies the lymph node basin containing SLN compared to conventional lymphoscintigram.
- Conditions
- Cervical Cancer
- Being tested
- Preoperative and intraoperative SLN Mapping
- Keywords
- Cervical Cancer, Sentinel Lymph Node, Lymphadenectomy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative and intraoperative SLN MappingProcedure or surgery
Patients will undergo preoperative SLN mapping, which includes an injection of a radiocolloid and lymphosinctogram and SPECT/CT. Patients will also receive an intraoperative injection of blue dye. A handheld probe will be utilized to detect radiolabelled or "hot" nodes and direct visualization will identify blue nodes which will be labelled "Sentinel Nodes" and sent to pathology for intraoperative frozen section.
| Study group | Role | What they receive |
|---|---|---|
| Sentinel lymph node mapping | Experimental | Patients who consent to the study will have preoperative and intraoperative SLN mapping performed. This will include injection of a radioisotope (Technetium 99) into the cervix and imaging (SPECT/CT) at Nuclear Medicine in the morning prior to surgery in an effort to identify the lymph node basin containing the sentinel nodes. Intraoperatively, blue dye will also be injected into the cervix to aid in location of the sentinel nodes. Receives: Procedure: Preoperative and intraoperative SLN Mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of sentinel lymph node (SLN) detection in patients with early invasive cervical cancer using a combined radioisotope and blue dye technique.
Measured: Three years
Secondary outcomes (1)
SLN status correspondence with the overall pelvic lymph node positivity (specificity) as determined by lymphadenectomy (gold standard).
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startJul 2010
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical 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
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Responsible party
- Sponsor
- Investigators
- Sarah Ferguson, MD, Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543775
- Sponsor's protocol ID
- 09-1003-CE
- Status last verified
- Jun 2019
- First submitted
- 2 Jun 2015
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Lymph Node Detection in Early Cervical Cancer
- ClinicalTrials.gov ID
- NCT02543775
- Acronym / sponsor ID
- 09-1003-CE
- Conditions
- Cervical Cancer
- Keywords
- Cervical Cancer, Sentinel Lymph Node, Lymphadenectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Study start
- Jul 2010 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 7 Sep 2015 (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 primary objective of this study is to determine the feasibility of detecting the sentinel lymph node (SLN) in patients with early invasive cervical cancer using a combined radioisotope and blue dye technique.
The investigators hypothesize that the sentinel lymph node (first node draining the tumour/cervix) for early stage cervical cancer represents the status of the regional lymph node basin (pelvic lymph nodes) and identification of a negative SLN would negate the need for complete pelvic lymphadenectomy.
Detailed description
Cancers of the cervix that are small and appear to be contained in the cervix (early stage) have up to 20 percent chance of having pelvic lymph nodes involved. The standard therapy is removal of the uterus and cervix (radical hysterectomy) and removal of all pelvic lymph nodes for all women with early stage cervical cancer. This procedure can be associated with significant intraoperative and postoperative complications including increased risk of damage to blood vessels and nerves in the pelvic region (leading to bladder, bowel and sexual dysfunction) as well as lymphedema (swelling, particularly in the legs) associated with significant pelvic lymph tissue removal.
The objective of this study is to find a way to accurately identify the first lymph node that drains the tumour/cervix (SLN). If this SLN is correctly identified, and it's status (positive or negative for malignancy) is representative of the entire lymph node basin, a complete node dissection could be avoided. This could benefit many women with early stage cervical cancer, as a minority actually have evidence of disease in the nodes after surgery (between 5-20%) and limited lymph node sampling could prevent the associated complications of a full pelvic lymph node dissection.
This is a prospective cohort study. The population to be studied is patients with newly diagnosed early stage cervical cancer undergoing primary surgical intervention including radical hysterectomy and bilateral pelvic lymphadenectomy. On the morning of surgery, preoperative injection of a radiolabeled colloid will be performed in the Nuclear Medicine Department followed by SPECT/CT to visualize the radiolabelled dye. Patients will then be taken to the operating room for their planned procedure. After initiation of general anesthesia, blue dye will be injected into the patient's cervix. The surgery will proceed and all lymph nodes that are "blue" and/or "hot" will be removed surgically, their anatomic location and laterality documented and sent for frozen section intraoperatively. The radical hysterectomy or radical trachelectomy and complete systematic bilateral pelvic lymphadenectomy will then be performed. The SLN status reported by the pathologist based on the frozen section will be compared to the status of the other nodes removed after complete lymphadenectomy and reported in the final pathology report (after formalin fixation and paraffin embedding). All data on these patients will be prospectively collected.
This protocol will determine the feasibility of SLN mapping in women with early stage cervical cancer. The primary outcomes will be to measure the rate of detection of SLN using the combination of radiolabelled and blue dye (unilateral and bilateral detection rates will be reported) as well as the sensitivity and specificity of this technique, based on assessing how well the intraoperative reading of SLN frozen section corresponds with the final pathology lymph node status after examining all lymph nodes removed by complete pelvic lymphadenectomy.
In addition, the investigators will assess the usefulness of preoperative SPECT/CT in identifying SLN and whether this modality accurately identifies the lymph node basin containing SLN compared to conventional lymphoscintigram.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sentinel lymph node mapping | Experimental | Procedure: Preoperative and intraoperative SLN MappingPatients who consent to the study will have preoperative and intraoperative SLN mapping performed. This will include injection of a radioisotope (Technetium 99) into the cervix and imaging (SPECT/CT) at Nuclear Medicine in the morning prior to surgery in an effort to identify the lymph node basin containing the sentinel nodes. Intraoperatively, blue dye will also be injected into the cervix to aid in location of the sentinel nodes. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women with invasive adenocarcinoma or squamous cell carcinoma of the cervix
- Stages 1A1 (+LVSI), 1A2 and 1B1 (< 4 cm)
- If CT, MRI or PET have been performed preoperatively there must be no clear evidence of metastatic disease and/or parametrial involvement.
- Patients who have signed an approved informed consent.
- Patients who will undergo surgery that includes a radical hysterectomy and/or radical trachelectomy and bilateral lymphadenectomy via laparotomy, laparoscopy or robotic-assisted.
Key exclusion criteria (6 listed)
- Patients with known allergy to triphenylmethane compounds
- Pregnant patient
- Patients with previous retroperitoneal surgery
- Patients with previous history of pelvic/abdominal radiation
- Patients with recurrent cervical cancer
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 |
|---|---|---|
| Preoperative and intraoperative SLN MappingPatients will undergo preoperative SLN mapping, which includes an injection of a radiocolloid and lymphosinctogram and SPECT/CT. Patients will also receive an intraoperative injection of blue dye. A handheld probe will be utilized to detect radiolabelled or "hot" nodes and direct visualization will identify blue nodes which will be labelled "Sentinel Nodes" and sent to pathology for intraoperative frozen section. | Procedure or surgery | Sentinel lymph node mapping |
Primary outcome
Sensitivity of sentinel lymph node (SLN) detection in patients with early invasive cervical cancer using a combined radioisotope and blue dye technique.
Time frame: Three years
1 secondary outcome
SLN status correspondence with the overall pelvic lymph node positivity (specificity) as determined by lymphadenectomy (gold standard).
Time frame: Three years
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 18 Jun 2019.
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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
Princess Margaret Hospital, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative and intraoperative SLN Mapping in people with Cervical Cancer, run by University Health Network, Toronto 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 6 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 18 Jun 2019. 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?
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?
Sensitivity of sentinel lymph node (SLN) detection in patients with early invasive cervical cancer using a combined radioisotope and blue dye technique. (time frame: Three years). 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 18 Jun 2019.