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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Feasibility of One-Step Sentinel Lymph Node (SLN) Biopsy With Radiolabeled Methylene Blue (IND 70,627)

NCTNCT00784849 (opens ClinicalTrials.gov in a new tab)Other idLSU #6169
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
62 participants (actual)
Sponsor
Louisiana State University Health Sciences Center in New Orleans · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Nov 2004
Primary completion
Jun 2011
Completion
Jun 2011
First posted
4 Nov 2008 (estimated)
Last update posted
20 Jun 2012 (estimated)
Conditions
Breast Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20042006200820102012
  1. Ph 2

    Feasibility of One-Step Sentinel Lymph Node (SLN) Biopsy With Radiolabeled Methylene Blue (IND 70,627)

    NCT00784849

    Nov 2004 to Jun 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to develope a one-step procedure to perform a biopsy of axillary lymph nodes on the same side as the breast tumor in women diagnosed with breast cancer.

Interventions

  • Methylene blueDrug

Arms1

  • Experimental

    1

    One arm diagnostic

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. The Number of Participants That Have Sentinel Nodes Which Are Radioactive or Blue, or Radioactive and Blue or Have Efferent Blue Lymphatics Leading up to the Sentinel Node(s)

    Time frame · intraoperatively; up to 6 hours

Secondary outcomes(2)

  1. Safety (Allergic Reaction to Blue Dye)

    Time frame · intraoperatively up to 6 hours

    Registry description

    number of participants who had a systemic allergic reaction such as hives, shortness of breath, hypotension

  2. Superficial Skin Necrosis

    Time frame · 2 weeks postoperatively

    Registry description

    the number of participants who developed post-operative skin necrosis within 2 weeks of surgery

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· intraoperatively; up to 6 hours

The Number of Participants That Have Sentinel Nodes Which Are Radioactive or Blue, or Radioactive and Blue or Have Efferent Blue Lymphatics Leading up to the Sentinel Node(s)

GroupValue (participants)
Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue58
Secondary and other outcome results(2)
Secondary outcomeNumber· intraoperatively up to 6 hours

Safety (Allergic Reaction to Blue Dye)

GroupValue (participants)
Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue0
Secondary outcomeNumber· 2 weeks postoperatively

Superficial Skin Necrosis

GroupValue (participants)
Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Sentinel Lymph Node Biopsy With Radiolabeled Methylene BlueOne arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes–0 / 622 / 62

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Stage 0,I, II breast cancer * Clinical node status N0, N1 * No know allergy to iodine, lymphazurin or methylene blue dyes Exclusion Criteria: * Patient cannot be pregnant or nursing * Prisoners will not be eligible * Women under the age of 18 will not be eligible * Patients with a known allergy to iodine or methylene blue or lymphazurin blue dyes

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