Trial Outcomes & Findings for Detection of SLN in Patients With Endometrial Cancer Undergoing Robotic Assisted Staging: Comparison of ISB and ICG (NCT NCT02068820)
NCT ID: NCT02068820
Last Updated: 2019-09-10
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
through 6 weeks post-operative
Results posted on
2019-09-10
Participant Flow
Participant milestones
| Measure |
ISB Dye, Standard White Light
SLN mapping utilizing da Vinci surgical system with Isosulfan Blue (ISB) dye and standard white light imaging.
ISB dye and standard white light imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.
|
ICG Dye, FireFly Fluorescence Imaging
SLN mapping utilizing da Vinci surgical system with ISB dye and standard white light first, and then additionally, Indocyanine Green (ICG) dye and FireFly fluorescence imaging.
ISB dye and standard white light imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.
ICG dye and FireFly fluorescence imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system with ICG dye and FireFly fluorescence imaging.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
180
|
|
Overall Study
COMPLETED
|
20
|
180
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Detection of SLN in Patients With Endometrial Cancer Undergoing Robotic Assisted Staging: Comparison of ISB and ICG
Baseline characteristics by cohort
| Measure |
ISB Dye, Standard White Light
n=20 Participants
SLN mapping utilizing da Vinci surgical system with Isosulfan Blue (ISB) dye and standard white light imaging.
ISB dye and standard white light imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.
|
ICG Dye, FireFly Fluorescence Imaging
n=180 Participants
SLN mapping utilizing da Vinci surgical system with ISB dye and standard white light first, and then additionally, Indocyanine Green (ICG) dye and FireFly fluorescence imaging.
ISB dye and standard white light imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.
ICG dye and FireFly fluorescence imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system with ICG dye and FireFly fluorescence imaging.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Age
|
66.0 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
64.4 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
64.5 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: through 6 weeks post-operativePopulation: The ISB dye alone group (n=20) and the ICG group (n=180) are combined, because both groups received the ISB dye.
Outcome measures
| Measure |
ISB Dye, Standard White Light
n=200 Participants
SLN mapping utilizing da Vinci surgical system with Isosulfan Blue (ISB) dye and standard white light imaging.
ISB dye and standard white light imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.
|
ICG Dye, FireFly Fluorescence Imaging
n=180 Participants
SLN mapping utilizing da Vinci surgical system with ISB dye and standard white light first, and then additionally, Indocyanine Green (ICG) dye and FireFly fluorescence imaging.
ISB dye and standard white light imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.
ICG dye and FireFly fluorescence imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system with ICG dye and FireFly fluorescence imaging.
|
Both IHC and H&E
Positive node identified with both IHC and H\&E dye
|
|---|---|---|---|
|
Number of Pelvic Sentinel Lymph Nodes (SLN) in Endometrial Cancer Patients Detected by Either ICG and/or ISB Dyes.
|
1.25 nodes
Standard Deviation .901
|
2.03 nodes
Standard Deviation .720
|
—
|
SECONDARY outcome
Timeframe: through 6 weeks post-operativePopulation: Comparison of metastatic disease (yes or no) with ICG dye node detection (yes or no)
The standard definition for negative predictive value was used to calculate NPV. There was one false negative SLN in this study, 39 true positive sentinel lymph nodes, and 140 negative pelvic metastatic patients. NPV = 140/141=99.3%
Outcome measures
| Measure |
ISB Dye, Standard White Light
n=141 Participants
SLN mapping utilizing da Vinci surgical system with Isosulfan Blue (ISB) dye and standard white light imaging.
ISB dye and standard white light imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.
|
ICG Dye, FireFly Fluorescence Imaging
n=39 Participants
SLN mapping utilizing da Vinci surgical system with ISB dye and standard white light first, and then additionally, Indocyanine Green (ICG) dye and FireFly fluorescence imaging.
ISB dye and standard white light imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.
ICG dye and FireFly fluorescence imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system with ICG dye and FireFly fluorescence imaging.
|
Both IHC and H&E
Positive node identified with both IHC and H\&E dye
|
|---|---|---|---|
|
Negative Predictive Value (NPV) of Pelvic SLN in Endometrial Cancer in Relation to the Number of Nodes With Metastasis.
Metastatic Disease
|
1 Participants
|
39 Participants
|
—
|
|
Negative Predictive Value (NPV) of Pelvic SLN in Endometrial Cancer in Relation to the Number of Nodes With Metastasis.
Non Metastatic Disease
|
140 Participants
|
0 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: through 6 weeks post-operativePopulation: These are positive sentinel lymph nodes
Of the 127 positive nodes with pathology information, the percentage of each type of node will be summarized by the staining method. Statistical testing of the individual staining methods compared to both will be computed using Chi-square test of independence.
Outcome measures
| Measure |
ISB Dye, Standard White Light
n=18 Nodes
SLN mapping utilizing da Vinci surgical system with Isosulfan Blue (ISB) dye and standard white light imaging.
ISB dye and standard white light imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.
|
ICG Dye, FireFly Fluorescence Imaging
n=91 Nodes
SLN mapping utilizing da Vinci surgical system with ISB dye and standard white light first, and then additionally, Indocyanine Green (ICG) dye and FireFly fluorescence imaging.
ISB dye and standard white light imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.
ICG dye and FireFly fluorescence imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system with ICG dye and FireFly fluorescence imaging.
|
Both IHC and H&E
n=18 Nodes
Positive node identified with both IHC and H\&E dye
|
|---|---|---|---|
|
Number of Pelvic Sentinal Lymph Nodal Metastasis in Regard to Staining by Immunohistochemical (IHC) Staining in Comparison to Standard Hematoxylin and Eosin (H&E).
Sentinel Nodes
|
16 nodes
|
31 nodes
|
16 nodes
|
|
Number of Pelvic Sentinal Lymph Nodal Metastasis in Regard to Staining by Immunohistochemical (IHC) Staining in Comparison to Standard Hematoxylin and Eosin (H&E).
Pelvic Nodes Only
|
1 nodes
|
36 nodes
|
2 nodes
|
|
Number of Pelvic Sentinal Lymph Nodal Metastasis in Regard to Staining by Immunohistochemical (IHC) Staining in Comparison to Standard Hematoxylin and Eosin (H&E).
Aortic
|
1 nodes
|
14 nodes
|
0 nodes
|
|
Number of Pelvic Sentinal Lymph Nodal Metastasis in Regard to Staining by Immunohistochemical (IHC) Staining in Comparison to Standard Hematoxylin and Eosin (H&E).
Infrarenal
|
0 nodes
|
10 nodes
|
0 nodes
|
Adverse Events
ISB Only Adverse Events
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
ICG Adverse Events
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ISB Only Adverse Events
n=20 participants at risk
ISB only Adverse Events categories reported during post-op follow up 6 weeks
|
ICG Adverse Events
n=180 participants at risk
ICG Adverse Events categories reported during post-op follow up 6 weeks
|
|---|---|---|
|
Reproductive system and breast disorders
Reproductive system complications
|
10.0%
2/20 • Post-op follow up 6 weeks
|
3.9%
7/180 • Post-op follow up 6 weeks
|
|
Renal and urinary disorders
Renal and urinary complications
|
0.00%
0/20 • Post-op follow up 6 weeks
|
2.2%
4/180 • Post-op follow up 6 weeks
|
|
Surgical and medical procedures
Wound complications
|
10.0%
2/20 • Post-op follow up 6 weeks
|
0.56%
1/180 • Post-op follow up 6 weeks
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
5.0%
1/20 • Post-op follow up 6 weeks
|
2.8%
5/180 • Post-op follow up 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic, and pulmonary complications
|
0.00%
0/20 • Post-op follow up 6 weeks
|
1.7%
3/180 • Post-op follow up 6 weeks
|
|
Cardiac disorders
Cardiac complications
|
5.0%
1/20 • Post-op follow up 6 weeks
|
1.7%
3/180 • Post-op follow up 6 weeks
|
|
Vascular disorders
Vascular complications
|
5.0%
1/20 • Post-op follow up 6 weeks
|
0.00%
0/180 • Post-op follow up 6 weeks
|
|
Gastrointestinal disorders
Gastrointestinal complications
|
0.00%
0/20 • Post-op follow up 6 weeks
|
1.7%
3/180 • Post-op follow up 6 weeks
|
|
General disorders
General disorders and administration site conditions
|
5.0%
1/20 • Post-op follow up 6 weeks
|
2.2%
4/180 • Post-op follow up 6 weeks
|
|
Blood and lymphatic system disorders
Blood and lymphatic system complications
|
10.0%
2/20 • Post-op follow up 6 weeks
|
4.4%
8/180 • Post-op follow up 6 weeks
|
Additional Information
Robert W. Holloway
Florida Hospital Gynecologic Oncology
Phone: 407-303-2400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place