CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 39 enrolled
Drug / intervention
Isosulfan blue +5 moredrug
Likely dose
Isosulfan Blue 2 cc total (four 0.5 cc aliquots); Technetium Tc 99m Sulfur Colloid total 1.0 mci/2ccAI-extracted
Key inclusion· 6
  • Histologically confirmed breast cancer
  • Stage I or II disease (T1-T2, N0, M0/MX)
  • Medially or centrally located lesion
  • No clinically positive axillary nodes
Key exclusion· 8
  • Chest wall invasion (T3 disease)
  • Multicentric disease
  • Prior thoracic or cardiac surgery
  • Prior ipsilateral chest tube placement

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

Search/NCT00450723
NCT00450723N/ACompleted

Thoracoscopic Internal Mammary Sentinel Node Biopsy

University of Miami·interventional·Posted Mar 22, 2007·Updated Feb 7, 2017

In Brief

A clinical study evaluating Isosulfan blue, Axillary Lymph Node Dissection, and 4 other interventions for Breast Cancer. Completed, enrolled 39 participants across 1 site.

Detailed Summary

RATIONALE: Diagnostic procedures, such as thoracoscopic sentinel lymph node biopsy, may help find breast cancer that has spread to lymph nodes between the breasts. It may also help doctors plan the best treatment. PURPOSE: This clinical trial is studying how well thoracoscopic sentinel lymph node biopsy finds sentinel lymph nodes that are located between the breasts in patients with stage I or stage II breast cancer.

Study Details

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

Timeline

N/ACompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 22, 2007
Enrollment StartMay 1, 2004
Primary CompletionJan 1, 2011
Study CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 19.3 years ago

Interventions

Isosulfan bluedrug

Administered pre-surgery; injection of 2 cc of Isosulfan Blue in four equal aliquots of 0.5 cc as routinely done for the axillary sentinel node procedure.

Axillary Lymph Node Dissectionprocedure

Axillary Lymph Node Dissection

Surgeryprocedure

The surgery will be performed under general anesthesia with a single lumen endo-tracheal tube. The patient will be laid in a semi decubitus position on the opposite side with the ipsilateral arm bent over the head and attached to an arm rest.

Sentinel Lymph Node Biopsyprocedure

Sentinel Lymph Node Biopsy

Thoracoscopic Surgeryprocedure

Performed only if internal mammary sentinel node cannot be retrieved via same incision of lumpectomy/mastectomy.

Technetium Tc 99m Sulfur Colloidradiation

Two to three hours prior to surgery, a peritumoral injection of filtered Technetium Sulfur Colloid will be performed in four 0.25 mci/2cc aliquots