CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 699 enrolled
Drug / intervention
Sentinel Node Biopsyprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00575744
NCT00575744Phase 2Completed
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Sentinel Lymph Node Biopsy Using Peritumoral Injection With Blue Dye Confirmation

University of Arkansas·interventional·Posted Dec 18, 2007·Updated Oct 27, 2016

In Brief

A Phase 2 clinical trial evaluating Sentinel Node Biopsy for Breast Cancer. Completed, enrolled 699 participants across 1 site.

Detailed Summary

We continue to collect information in support of the hypothesis that the histology of the first draining lymph node (sentinel node) accurately predicts the histology of the rest of the axillary lymph nodes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 18, 2007
Enrollment StartDec 1, 1998
Primary CompletionOct 1, 2010
Study CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 11.8 yearsPosted 18.5 years ago

Interventions

Sentinel Node Biopsyprocedure

Once the patient is asleep under anesthetic, they receive an intraoperative injection of 1.0 mCi of Technetium-99 sulfur colloid into normal breast tissue surrounding the primary cancer or biopsy cavity directed subareolar or around the tumor. This is followed by blue dye injected in the subareolar complex approximately 5 minutes prior to incision. The sentinel node biopsy is performed, followed by lumpectomy/mastectomy, and a completion axillary node dissection if the sentinel node(s) were positive.