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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: Completed NA study, sponsored by Indiana University.
NCT01673022 is a NA study that has completed, run by Indiana University. The registered enrollment target is 430 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To estimate the sensitivity of the sentinel lymph node in the determination of lymph node metastases in patients with invasive carcinoma of the cervix and uterus using Indocyanine Green (ICG) and robotic assisted near infrared (NIR) imaging. Sensitivity is defined as the proportion of sentinel lymph node: number of participants with, determined to be metastatic by both IGR/NIR and pathology out of the sentinel lymph nodes found to be metastatic by pathology.
Interventions
- DRUG IC Green
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 430 participants |
| Start Date | 2012-05 |
| Est. Completion | 2017-01 |
| Phase | NA |
What the finished NCT01673022 record still lists
NCT01673022 is an interventional study that assigns participants to a tested intervention. The registered 430 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 1 intervention - of which IC Green is the first listed.
NCT01673022 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01673022's enrollment target sits among peer trials
430 235th of 2000 higher than 1,765 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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