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NCT01673022 · ClinicalTrials.gov registry record · NA
Determining the Sensitivity of Sentinel Lymph Nodes Identified With Robotic Fluorescence Imaging
A NA study, sponsored by Indiana University.
- Completed
- Registry status
- NA
- Development phase
- 430
- Enrollment target
NCT01673022 is a NA study that has completed, run by Indiana University. The registered enrollment target is 430 participants.
The verdict
NCT01673022, a NA study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- NA
- Development phase
- 430 participants
- Enrollment target
Study Summary
Description: This is a multi-institutional study investigating the sensitivity and negative predictive value of sentinel lymph nodes mapped with robotic assisted near infrared imaging after cervical injection of indocyanine green (ICG) dye for women with stage I endometrial or cervical cancer at the time of their robotic surgical staging. Patients will receive cervical injection of 1mg ICG after induction of anesthesia followed by sentinel lymph node mapping using robotic assisted fluorescence imaging. The sentinel lymph nodes identified will be removed and sent for ultraprocessing by pathology. The non-sentinel pelvic and para-aortic (if indicated) non-sentinel nodes will be removed and sent for routine pathologic processing according to standard of care for these surgical procedures. The pathologic results of the sentinel and non-sentinel nodes will be evaluated for sensitivity and negative predictive value in their ability to detect metastatic disease.
Interventions
- DRUG IC Green
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 430 participants |
| Start Date | 2012-05 |
| Est. Completion | 2017-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01673022
The ClinicalTrials.gov registry entry for NCT01673022 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 430 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which IC Green is the first listed.
NCT01673022 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01673022 about?
NCT01673022 is a clinical study titled "Determining the Sensitivity of Sentinel Lymph Nodes Identified With Robotic Fluorescence Imaging". Description: This is a multi-institutional study investigating the sensitivity and negative predictive value of sentinel lymph nodes mapped with robotic assisted near infrared imaging after cervical injection of indocyanine green (ICG) dye for women with stage I endometrial or cervical cancer at th...
What is the current status of trial NCT01673022?
This trial is currently completed. It is a NA study. The enrollment target is 430 participants. The study started on 2012-05. Estimated completion is 2017-01.
What interventions are being tested in trial NCT01673022?
The interventions under investigation include: IC Green (DRUG).
Who is sponsoring clinical trial NCT01673022?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
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