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NCT01381315 · ClinicalTrials.gov registry record · Phase 2
Axillary Reverse Mapping
A Phase 2 study, sponsored by University of Kansas Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 210
- Enrollment target
NCT01381315: Completed Phase 2 study, sponsored by University of Kansas Medical Center.
NCT01381315 is a Phase 2 study that has completed, run by University of Kansas Medical Center. The registered enrollment target is 210 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01381315, a Phase 2 study, has completed, sponsored by University of Kansas Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 210 participants
- Enrollment target
Study Summary
It has been hypothesized that the proximity of the anatomic locations of the arm lymphatic drainage system to the breast lymphatic system in the axilla put the arm lymphatics at risk for disruption during a sentinel lymph node biopsy (SLNB) and/or axillary lymph node dissection (ALND). Therefore, mapping the drainage of the arm in addition to the drainage of the breast during the procedure would potentially decrease the incidence of arm lymphatic disruption and subsequent development of lymphedema while providing adequate axillary breast nodes needed for staging.
Primary Outcome
The primary objective of this study is to assess and test the lymphedema rates six times at the following intervals: Pre-surgery - baseline, at 6 months, and yearly for 4 years. Since the historical control rates are different (5% for SLNB only and 13% for ALND with or without SLNB) two tests will be performed.
Interventions
- PROCEDURE Injection of isotope
- PROCEDURE Axillary lymph node dissection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2009-09 |
| Est. Completion | 2016-05 |
| Phase | Phase 2 |
What the finished NCT01381315 record still lists
NCT01381315 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% higher).
The record links to 0 conditions, and to 2 interventions - of which Injection of isotope is the first listed.
NCT01381315 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01381315 about?
NCT01381315 is a clinical study titled "Axillary Reverse Mapping". It has been hypothesized that the proximity of the anatomic locations of the arm lymphatic drainage system to the breast lymphatic system in the axilla put the arm lymphatics at risk for disruption during a sentinel lymph node biopsy (SLNB) and/or axillary lymph node dissection (ALND). Therefore, ma...
What is the current status of trial NCT01381315?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 210 participants. The study started on 2009-09. Estimated completion is 2016-05.
What interventions are being tested in trial NCT01381315?
The interventions under investigation include: Injection of isotope (PROCEDURE), Axillary lymph node dissection (PROCEDURE).
Who is sponsoring clinical trial NCT01381315?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01381315's enrollment target sits among peer trials
210 290th of 2000 higher than 1,707 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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