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NCT00645541 · ClinicalTrials.gov registry record · Phase 1
Axillary Reverse Mapping for Invasive Carcinoma of the Breast
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT00645541: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00645541 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00645541, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
Primary Objectives: * To determine the feasibility of axillary reverse mapping (ARM) in patients undergoing axillary lymph node dissection for breast cancer therapy. * To determine the incidence of breast cancer metastasis in lymph nodes draining in the arm as identified by axillary reverse mapping. * To determine the safety of axillary reverse mapping.
Primary Outcome
Axillary reverse mapping (ARM) performed using 2 - 5cc of isosulfan blue, injected into the inner arm prior to skin incision for the axillary lymph node dissection. Blue channels identified during surgery and locations compared to axillary vein. Any blue nodes within the standard axillary lymph node dissection field removed then sent to pathology as a separate specimen labeled "axillary reverse mapping nodes" and evaluated with serial sectioning, and hematoxylin-eosin stain (H\&E) as well as imm
Interventions
- PROCEDURE Axillary Reverse Mapping
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2008-03 |
| Est. Completion | 2010-11 |
| Phase | Phase 1 |
What the finished NCT00645541 record still lists
NCT00645541 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 1 intervention - of which Axillary Reverse Mapping is the first listed.
NCT00645541 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00645541 about?
NCT00645541 is a clinical study titled "Axillary Reverse Mapping for Invasive Carcinoma of the Breast". Primary Objectives: * To determine the feasibility of axillary reverse mapping (ARM) in patients undergoing axillary lymph node dissection for breast cancer therapy. * To determine the incidence of breast cancer metastasis in lymph nodes draining in the arm as identified by axillary reverse mapping...
What is the current status of trial NCT00645541?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2008-03. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00645541?
The interventions under investigation include: Axillary Reverse Mapping (PROCEDURE).
Who is sponsoring clinical trial NCT00645541?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00645541's enrollment target sits among peer trials
35 1258th of 2000 higher than 728 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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