NCT00438477

Brief Summary

RATIONALE: Diagnostic procedures, such as lymphoscintigraphy using an injection under the nipple or near the tumor, may help doctors find out how far the disease has spread. PURPOSE: This clinical trial is studying two different injection methods to compare how well they find the sentinel lymph node during lymphatic mapping and sentinel lymph node biopsy in patients with invasive breast cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Jun 2005

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2007

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

July 30, 2012

Status Verified

July 1, 2012

Enrollment Period

1.2 years

First QC Date

February 20, 2007

Last Update Submit

July 27, 2012

Conditions

Breast Cancer

Keywords

recurrent breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage II breast cancer

Outcome Measures

Primary Outcomes (2)

  • Lymphatic drainage patterns as determined by peritumoral and subareolar injections

    Evaluate outcome descriptively.

    12 months to collect data

  • Identification rate of sentinel nodes and negative predictive value associated with subareolar injection

    Evaluate outcome descriptively.

    12 months to collecte data

Study Arms (1)

Injection Methods

EXPERIMENTAL

One injection site with radioactive tracer intraparenchymal/peritumoral (around the tumor), and other subareolar (around the nipple)

Drug: Isosulfan BlueProcedure: LymphangiographyRadiation: Technetium Tc 99m sulfur colloid

Interventions

Isosulfan BlueDRUG

At time of surgery, breast injected with 3-5 cc of isosulfan blue in subareolar or peritumoral position.

Also known as: lymphazurin
Injection Methods
LymphangiographyPROCEDURE

2 lymphoscintigraphy images performed following peritumoral and subareolar injection of breast

Injection Methods
Technetium Tc 99m sulfur colloidRADIATION

At least 2 days before scheduled surgery, receive technetium Tc 99m sulfur colloid by peritumoral injection; and again the day before surgery by subareolar injection. At the time of surgery, patients receive isosulfan blue by subareolar injection.

Injection Methods

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have either pathologic, radiologic or clinical evidence of breast cancer with invasion, suspicious for invasion or microinvasion.
  • Patients who are candidates for a total mastectomy or segmental mastectomy or axillary dissection.
  • Patients who have undergone neoadjuvant chemotherapy who have an FNA confirmed lymph node positive for metastatic disease prior to induction chemotherapy and are then found to have grossly palpable disease but are ultrasound node negative at time of study entry.
  • Patients must sign an informed consent and be registered before the procedure is performed.

You may not qualify if:

  • A pregnancy test will be required preoperatively in women of childbearing potential and patients who are pregnant will be excluded from this study.
  • Patients who have undergone neoadjuvant chemotherapy who have an FNA confirmed lymph node metastatic disease prior to induction chemotherapy and are then found to have grossly suspicious palpable disease and are ultrasound node positive at the time of study entry.
  • Patients with known allergy to isosulfan blue dye or any related compounds.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

iso-sulfan blueTechnetium Tc 99m Sulfur Colloid

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Sulfur CompoundsInorganic ChemicalsTechnetium Compounds

Study Officials

  • Gildy V. Babiera, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

  • Ebrahim Delpassand, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2007

First Posted

February 22, 2007

Study Start

June 1, 2005

Primary Completion

August 1, 2006

Study Completion

April 1, 2008

Last Updated

July 30, 2012

Record last verified: 2012-07

Locations

US(1)