Stage I Endometrial CarcinomaNCT01939028
Lymph Node Mapping in Patients With Newly Diagnosed Endometrial Cancer Undergoing Surgery
A study testing lymph node mapping, sentinel lymph node biopsy and isosulfan blue in people with Stage I Endometrial Carcinoma and Stage II Endometrial Carcinoma, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial studies lymph node mapping in patients with newly diagnosed endometrial cancer undergoing surgery. Lymph node mapping may help in planning surgery to remove endometrial cancer and affected lymph nodes. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Stage I Endometrial Carcinoma, Stage II Endometrial Carcinoma, Stage III Endometrial Carcinoma
- What is being tested?
- lymph node mapping, sentinel lymph node biopsy and isosulfan blue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women must have newly diagnosed histologically or cytologically confirmed endometrial cancer
- Women should have received no prior therapy for their disease
- Women who are planning to undergo hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymphadenectomy for the management of their endometrial cancer
- Women must have the ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Women who are receiving any other investigational agents
- Women with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to isosulfan blue or indocyanine green or other agents used in this study
- Women with hypersensitivity to phenylmethane compounds, or a history of allergic reaction to iodides
- Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Women with a history of prior loop electrosurgical excision procedure (LEEP) or cone procedures performed on their cervix
- Women with a history of lymphedema, lymphoma, or lymphatic hyperplasia (Castleman disease)
- Women with a history of a prior malignancy
- Women may also be excluded at the discretion of their surgeon if he or she feels that the patient is not an appropriate candidate
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: Sentinel Lymph Node Mapping for Endometrial Cancer
This clinical trial studies lymph node mapping in patients with newly diagnosed endometrial cancer undergoing surgery. Lymph node mapping may help in planning surgery to remove endometrial cancer and affected lymph nodes.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the detection rate, sensitivity, and negative predictive value of sentinel lymph node (SLN) biopsy in endometrial cancer patients.
SECONDARY OBJECTIVES:
- To compare different surgical modalities (open procedures, minimally invasive procedures, and single-site technology) and different injectants (isosulfan blue and indocyanine green) for SLN biopsy.
II. To determine total operating room time (from the time the patient enters the room to the time the patient leaves the room) as well as console time (robotic)/operating time for minimally invasive procedures.
OUTLINE:
Patients undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy.
After completion of study treatment, patients are followed up at 2-4 weeks.
- Conditions
- Stage I Endometrial Carcinoma, Stage II Endometrial Carcinoma, Stage III Endometrial Carcinoma, Stage IV Endometrial Carcinoma
- Being tested
- lymph node mapping, sentinel lymph node biopsy, isosulfan blue, indocyanine green solution, therapeutic conventional surgery
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lymph node mappingProcedure or surgery
Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution
sentinel lymph node biopsyProcedure or surgery
Also called sentinel node biopsy
Undergo SLN biopsy
isosulfan blueDrug
Also called Lymphazurin, N-[4-[4-(diethylamino)phenyl] (2,5-disulfophenyl) Methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide
Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution
indocyanine green solutionDrug
Also called IC-GREEN, ICG solution
Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution
therapeutic conventional surgeryProcedure or surgery
Undergo hysterectomy, bilateral salpingo-oophorectomy and/or complete pelvic lymphadenectomy
lymphadenectomyProcedure or surgery
Undergo para-aortic lymphadenectomy
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (SLN mapping, biopsy, surgery) | Experimental | Patients undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy. Receives: Procedure: lymph node mapping; Procedure: sentinel lymph node biopsy; Drug: isosulfan blue; Drug: indocyanine green solution; Procedure: therapeutic conventional surgery; Procedure: lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of Sentential Lymph Node (SLN) Biopsy
Sensitivity estimated as the proportion of true positives among participants with lymph node metastases. Sensitivity Calculation= the number of patients with a positive SLN over those patients with a positive SLN plus those patients with a false negative lymph node.
Measured: Up to 4 weeks
Number of Participants in Whom a SLN is Detected
Detection Rate as defined by number of participants in whom a SLN is detected
Measured: Up to 4 weeks
Percent of Hemipelvises Identified With SLN
Detection rate, as defined by percent of hemipelvises identified with SLN
Measured: Up to 4 weeks
Number of Participants With Sentinel Nodes Per Side of Pelvis
Detection rate, as defined as number of participants with a sentinel node found per side of pelvis
Measured: Up to 4 weeks
False Negative Rate as Defined as Proportion of Participants With False Negative Detection
False negative rate = 1-sensitivity or the number of patients with a false negative SLN over the number of patients with a positive SLN plus those with a false negative lymph node
Measured: Up to 4 weeks
Percent of True Positive SLN Identified With Surgical Modalities (Open Procedures, Minimally Invasive Procedures, and Single-site Technology)
The percent of true positive SLN identified with surgical modalities using pairwise comparisons for each surgical modality. Comparisons will be performed using two sample tests of proportions based on a normal approximation.
Measured: Up to 4 weeks
Secondary outcomes (2)
Percent of True Positive SLNs Using Isosulfan Blue and Indocyanine Green Solution
Percent of true positive SLN identified will be compared between injectants utilized using a two sample test of proportions based on a normal approximation. Comparisons will be performed using two sample tests of proportions based on a normal approximation.
Measured: Up to 4 weeks
Total Operating Room Time in Minutes
Total operating room time will be estimated as a mean with 95% confidence interval if the data have an approximately normal distribution. Otherwise, the median and a bootstrapped 95% confidence interval for the median will be reported. Similar summaries will be provided for the console time (robotic)/ operating time.
Measured: From the time the patient enters the room to the time the patient leaves the room, assessed up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startJul 2013
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: Slow Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stage I Endometrial CarcinomaStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chad Michener, MD, Principal investigator, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939028
- Sponsor's protocol ID
- CASE9813
- Other IDs
- NCI-2013-01309
- Status last verified
- Aug 2020
- First submitted
- 10 Jul 2013
- Last updated
- 27 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Lymph Node Mapping for Endometrial Cancer
- ClinicalTrials.gov ID
- NCT01939028
- Acronym / sponsor ID
- CASE9813
- Conditions
- Stage I Endometrial Carcinoma, Stage II Endometrial Carcinoma, Stage III Endometrial Carcinoma, Stage IV Endometrial Carcinoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accrual
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 11 Sep 2013 (estimated)
- Results
- Posted 17 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial studies lymph node mapping in patients with newly diagnosed endometrial cancer undergoing surgery. Lymph node mapping may help in planning surgery to remove endometrial cancer and affected lymph nodes.
Detailed description
PRIMARY OBJECTIVES:
- To determine the detection rate, sensitivity, and negative predictive value of sentinel lymph node (SLN) biopsy in endometrial cancer patients.
SECONDARY OBJECTIVES:
- To compare different surgical modalities (open procedures, minimally invasive procedures, and single-site technology) and different injectants (isosulfan blue and indocyanine green) for SLN biopsy.
II. To determine total operating room time (from the time the patient enters the room to the time the patient leaves the room) as well as console time (robotic)/operating time for minimally invasive procedures.
OUTLINE:
Patients undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy.
After completion of study treatment, patients are followed up at 2-4 weeks.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (SLN mapping, biopsy, surgery) | Experimental | Procedure: lymph node mapping, Procedure: sentinel lymph node biopsy, Drug: isosulfan blue, Drug: indocyanine green solution, Procedure: therapeutic conventional surgery, Procedure: lymphadenectomyPatients undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Women must have newly diagnosed histologically or cytologically confirmed endometrial cancer
- Women should have received no prior therapy for their disease
- Women who are planning to undergo hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymphadenectomy for the management of their endometrial cancer
- Women must have the ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (8 listed)
- Women who are receiving any other investigational agents
- Women with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to isosulfan blue or indocyanine green or other agents used in this study
- Women with hypersensitivity to phenylmethane compounds, or a history of allergic reaction to iodides
- Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Women with a history of prior loop electrosurgical excision procedure (LEEP) or cone procedures performed on their cervix
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 |
|---|---|---|
| lymph node mappingUndergo lymph node mapping using isosulfan blue and/or indocyanine green solution | Procedure or surgery | Diagnostic (SLN mapping, biopsy, surgery) |
| sentinel lymph node biopsyAlso: sentinel node biopsyUndergo SLN biopsy | Procedure or surgery | Diagnostic (SLN mapping, biopsy, surgery) |
| isosulfan blueAlso: Lymphazurin, N-[4-[4-(diethylamino)phenyl] (2,5-disulfophenyl) Methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxideUndergo lymph node mapping using isosulfan blue and/or indocyanine green solution | Drug | Diagnostic (SLN mapping, biopsy, surgery) |
| indocyanine green solutionAlso: IC-GREEN, ICG solutionUndergo lymph node mapping using isosulfan blue and/or indocyanine green solution | Drug | Diagnostic (SLN mapping, biopsy, surgery) |
| therapeutic conventional surgeryUndergo hysterectomy, bilateral salpingo-oophorectomy and/or complete pelvic lymphadenectomy | Procedure or surgery | Diagnostic (SLN mapping, biopsy, surgery) |
| lymphadenectomyUndergo para-aortic lymphadenectomy | Procedure or surgery | Diagnostic (SLN mapping, biopsy, surgery) |
Primary outcome
Sensitivity of Sentential Lymph Node (SLN) Biopsy
Time frame: Up to 4 weeks
Sensitivity estimated as the proportion of true positives among participants with lymph node metastases. Sensitivity Calculation= the number of patients with a positive SLN over those patients with a positive SLN plus those patients with a false negative lymph node.
Number of Participants in Whom a SLN is Detected
Time frame: Up to 4 weeks
Detection Rate as defined by number of participants in whom a SLN is detected
Percent of Hemipelvises Identified With SLN
Time frame: Up to 4 weeks
Detection rate, as defined by percent of hemipelvises identified with SLN
Number of Participants With Sentinel Nodes Per Side of Pelvis
Time frame: Up to 4 weeks
Detection rate, as defined as number of participants with a sentinel node found per side of pelvis
False Negative Rate as Defined as Proportion of Participants With False Negative Detection
Time frame: Up to 4 weeks
False negative rate = 1-sensitivity or the number of patients with a false negative SLN over the number of patients with a positive SLN plus those with a false negative lymph node
Percent of True Positive SLN Identified With Surgical Modalities (Open Procedures, Minimally Invasive Procedures, and Single-site Technology)
Time frame: Up to 4 weeks
The percent of true positive SLN identified with surgical modalities using pairwise comparisons for each surgical modality. Comparisons will be performed using two sample tests of proportions based on a normal approximation.
2 secondary outcomes
Percent of True Positive SLNs Using Isosulfan Blue and Indocyanine Green Solution
Time frame: Up to 4 weeks
Total Operating Room Time in Minutes
Time frame: From the time the patient enters the room to the time the patient leaves the room, assessed up to 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Chad Michener, MD principal investigator
Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lymph node mapping, sentinel lymph node biopsy and isosulfan blue in people with Stage I Endometrial Carcinoma and Stage II Endometrial Carcinoma, run by Case Comprehensive Cancer Center at 1 site in United States.
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 8 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: stopped early, as of the sponsor's last update on 27 Aug 2020. 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 United States. 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?
Yes. Results are posted in the registry (first posted 17 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Sentential Lymph Node (SLN) Biopsy (time frame: Up to 4 weeks). The study lists 6 primary outcomes in all. 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 27 Aug 2020.