Trial Outcomes & Findings for Lymph Node Mapping in Patients With Newly Diagnosed Endometrial Cancer Undergoing Surgery (NCT NCT01939028)
NCT ID: NCT01939028
Last Updated: 2020-08-27
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
58 participants
Primary outcome timeframe
Up to 4 weeks
Results posted on
2020-08-27
Participant Flow
Participant milestones
| Measure |
Diagnostic (SLN Mapping, Biopsy, Surgery)
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.
lymph node mapping: Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution
sentinel lymph node biopsy: Undergo SLN biopsy
isosulfan blue: Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution
indocyanine green solution: Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution
therapeutic conventional surgery: Undergo hysterectomy, bilateral salpingo-oophorectomy and/or complete pelvic lymphadenectomy
lymphadenectomy: Undergo para-aortic lymphadenectomy
|
|---|---|
|
Overall Study
STARTED
|
58
|
|
Overall Study
COMPLETED
|
46
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Diagnostic (SLN Mapping, Biopsy, Surgery)
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.
lymph node mapping: Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution
sentinel lymph node biopsy: Undergo SLN biopsy
isosulfan blue: Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution
indocyanine green solution: Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution
therapeutic conventional surgery: Undergo hysterectomy, bilateral salpingo-oophorectomy and/or complete pelvic lymphadenectomy
lymphadenectomy: Undergo para-aortic lymphadenectomy
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Physician Decision
|
7
|
Baseline Characteristics
Lymph Node Mapping in Patients With Newly Diagnosed Endometrial Cancer Undergoing Surgery
Baseline characteristics by cohort
| Measure |
Diagnostic (SLN Mapping, Biopsy, Surgery)
n=46 Participants
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.
|
|---|---|
|
Age, Customized
20-29 years
|
1 Participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
0 Participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
4 Participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
7 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
21 Participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
12 Participants
n=5 Participants
|
|
Age, Customized
80-89 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 4 weeksPopulation: Participants with with lymph node metastases
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.
Outcome measures
| Measure |
Diagnostic (SLN Mapping, Biopsy, Surgery)
n=13 Participants
Participants 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.
|
|---|---|
|
Sensitivity of Sentential Lymph Node (SLN) Biopsy
|
100 percent
|
PRIMARY outcome
Timeframe: Up to 4 weeksPopulation: Participants who completed study
Detection Rate as defined by number of participants in whom a SLN is detected
Outcome measures
| Measure |
Diagnostic (SLN Mapping, Biopsy, Surgery)
n=46 Participants
Participants 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.
|
|---|---|
|
Number of Participants in Whom a SLN is Detected
|
44 Participants
|
PRIMARY outcome
Timeframe: Up to 4 weeksPopulation: Participants who completed study
Detection rate, as defined by percent of hemipelvises identified with SLN
Outcome measures
| Measure |
Diagnostic (SLN Mapping, Biopsy, Surgery)
n=46 Participants
Participants 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.
|
|---|---|
|
Percent of Hemipelvises Identified With SLN
|
81.5 Percent of Hemipelvises
|
PRIMARY outcome
Timeframe: Up to 4 weeksPopulation: Participants who completed study
Detection rate, as defined as number of participants with a sentinel node found per side of pelvis
Outcome measures
| Measure |
Diagnostic (SLN Mapping, Biopsy, Surgery)
n=46 Participants
Participants 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.
|
|---|---|
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Number of Participants With Sentinel Nodes Per Side of Pelvis
Right side of pelvis
|
39 participants
|
|
Number of Participants With Sentinel Nodes Per Side of Pelvis
Left side of pelvis
|
36 participants
|
PRIMARY outcome
Timeframe: Up to 4 weeksPopulation: Participants who completed study
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
Outcome measures
| Measure |
Diagnostic (SLN Mapping, Biopsy, Surgery)
n=46 Participants
Participants 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.
|
|---|---|
|
False Negative Rate as Defined as Proportion of Participants With False Negative Detection
|
0 Proportion of participants
|
PRIMARY outcome
Timeframe: Up to 4 weeksPopulation: Participants who completed study
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.
Outcome measures
| Measure |
Diagnostic (SLN Mapping, Biopsy, Surgery)
n=46 Participants
Participants 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.
|
|---|---|
|
Percent of True Positive SLN Identified With Surgical Modalities (Open Procedures, Minimally Invasive Procedures, and Single-site Technology)
Laparoscopy
|
83.3 percentage of true positive SNLs
|
|
Percent of True Positive SLN Identified With Surgical Modalities (Open Procedures, Minimally Invasive Procedures, and Single-site Technology)
Robot
|
86.4 percentage of true positive SNLs
|
|
Percent of True Positive SLN Identified With Surgical Modalities (Open Procedures, Minimally Invasive Procedures, and Single-site Technology)
Single port
|
79.0 percentage of true positive SNLs
|
SECONDARY outcome
Timeframe: Up to 4 weeksPopulation: Participants who completed study
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.
Outcome measures
| Measure |
Diagnostic (SLN Mapping, Biopsy, Surgery)
n=46 Participants
Participants 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.
|
|---|---|
|
Percent of True Positive SLNs Using Isosulfan Blue and Indocyanine Green Solution
indocyanine green
|
86.54 Percentage of true positive SLNs
|
|
Percent of True Positive SLNs Using Isosulfan Blue and Indocyanine Green Solution
Blue dye
|
75 Percentage of true positive SLNs
|
SECONDARY outcome
Timeframe: From the time the patient enters the room to the time the patient leaves the room, assessed up to 4 weeksPopulation: Participants who completed study
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.
Outcome measures
| Measure |
Diagnostic (SLN Mapping, Biopsy, Surgery)
n=46 Participants
Participants 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.
|
|---|---|
|
Total Operating Room Time in Minutes
|
158.5 minutes
Interval 138.91 to 178.09
|
Adverse Events
Diagnostic (SLN Mapping, Biopsy, Surgery)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Diagnostic (SLN Mapping, Biopsy, Surgery)
n=58 participants at risk
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.
|
|---|---|
|
Cardiac disorders
New onset atrial fibrillation
|
1.7%
1/58 • Number of events 1 • Up to 30 days from last treatment dose
|
Additional Information
Dr. Chad Michener
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Phone: 216-444-6601
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place