N/A
Completed N=200
Detection of SLN in Patients With Endometrial Cancer Undergoing Robotic Assisted Staging: Comparison of ISB and ICG
Source: ClinicalTrials.gov NCT02068820 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Number of Pelvic Sentinel Lymph Nodes (SLN) in Endometrial Cancer Patients Detected by Either ICG and/or ISB Dyes. — 1.25; 2.03 nodes
Summary
The investigators hypothesis is that if sensitivity and specificity are found to be significantly higher than the current reports with Technesium-99 and ISB colorimetric dye, SLN biopsies might allow omission of full lymphadenectomy in lower-risk cases, thereby limiting peri-operative morbidity. SLN biopsies might also improve the detection of metastatic disease, essentially lowering the recognized false-negative rate of standard lymphadenectomy analyzed by routine H&E pathologic analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Pelvic Sentinel Lymph Nodes (SLN) in Endometrial Cancer Patients Detected by Either ICG and/or ISB Dyes. |
1.25; 2.03 | — |
| SECONDARY Negative Predictive Value (NPV) of Pelvic SLN in Endometrial Cancer in Relation to the Number of Nodes With Metastasis. |
1; 39; 140; 0 | — |
Eligibility Criteria
Inclusion Criteria
- The patient must be ≥18 and ≤85 years of age.
- The patient must be female.
- The patient must be willing and able to provide informed consent.
- The patient is willing and able to comply with the study protocol.
- The patient has endometrial cancer and is scheduled for robotic hysterectomy and lymphadenectomy.
- The patient agrees to follow-up examinations out to 6-weeks post-treatment
Exclusion Criteria
- The patient is not a candidate for robotic assisted hysterectomy and lymphadenectomy.
- The patient has known or suspected allergies to iodine, ICG or ISB.
- The patient has hepatic dysfunction confirmed by elevated liver function studies (i.e., hepatic enzyme SGOT, SGPT or Bilirubin > 2 x normal (based on reference values from the laboratory used by the patient)
Data sourced from ClinicalTrials.gov (NCT02068820). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.