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NCT01276054 · ClinicalTrials.gov registry record · Phase 2
Sentinel and/or Axillary Lymph Node Biopsy With or Without Axillary Reverse Mapping in Reducing Incidence and Severity of Arm Lymphedema in Stage 0-2 Patients.
A Phase 2 study, sponsored by University of Southern California.
- Terminated
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT01276054: Clinical Trial Phase 2 study, sponsored by University of Southern California.
NCT01276054 is a Phase 2 study that was terminated before completion, run by University of Southern California. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01276054, a Phase 2 study, was terminated before completion, sponsored by University of Southern California.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study Summary
Lymph node biopsy followed by axillary reverse mapping may reduce the incidence and severity of arm lymphedema. This randomized phase II trial is studying how well sentinel and/or axillary lymph node biopsy with or without axillary reverse mapping works in reducing incidence and severity of lymphedema in patients with resectable stage 0-II breast cancer
Primary Outcome
LE is defined using the CTCAE v3 definition: a \>5-10% increase in the inter-limb volume in the ipsilateral arm compared to the unaffected arm.
Interventions
- PROCEDURE sentinel lymph node biopsy
- DRUG indocyanine green solution
- DRUG methylene blue
- RADIATION technetium Tc 99m sulfur colloid
- PROCEDURE axillary lymph node biopsy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2010-12 |
| Est. Completion | 2011-10 |
| Phase | Phase 2 |
Why NCT01276054 stopped before completion
NCT01276054 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 5 interventions - of which sentinel lymph node biopsy is the first listed.
NCT01276054 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01276054 about?
NCT01276054 is a clinical study titled "Sentinel and/or Axillary Lymph Node Biopsy With or Without Axillary Reverse Mapping in Reducing Incidence and Severity of Arm Lymphedema in Stage 0-2 Patients.". Lymph node biopsy followed by axillary reverse mapping may reduce the incidence and severity of arm lymphedema. This randomized phase II trial is studying how well sentinel and/or axillary lymph node biopsy with or without axillary reverse mapping works in reducing incidence and severity of lymphede...
What is the current status of trial NCT01276054?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2010-12. Estimated completion is 2011-10.
What interventions are being tested in trial NCT01276054?
The interventions under investigation include: sentinel lymph node biopsy (PROCEDURE), indocyanine green solution (DRUG), methylene blue (DRUG), technetium Tc 99m sulfur colloid (RADIATION), axillary lymph node biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT01276054?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01276054's enrollment target sits among peer trials
4 2001st of 2000 the lowest 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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