Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Injection Methods in Finding the Sentinel Lymph Node During Lymphatic Mapping and Sentinel Lymph Node Biopsy in Patients With Invasive Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Diagnostic	Closed	Not specified	NCI	MDA-ID-01538 NCT00438477

Special Category: NCI Avon award trial

Objectives

1. Compare subareolar injection with peritumoral injection in identifying the sentinel node during breast lymphatic mapping in patients with invasive breast cancer.
2. Compare the lymphatic drainage patterns using lymphoscintigraphy of the breast with subareolar injection vs peritumoral injection.

Entry Criteria

Disease Characteristics:

• Histologically, radiologically, or clinically confirmed breast cancer
  • Invasive disease or suspicious for invasion or microinvasion



• Candidate for axillary lymph node dissection



• Was lymph node positive for metastatic disease by fine needle aspiration prior to neoadjuvant induction chemotherapy



• Has grossly palpable disease BUT is ultrasound node negative at study entry

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Patient Characteristics:

Age

• Not specified

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No known allergy to isosulfan blue dye or any related compounds

Expected Enrollment

A total of 100 patients will be accrued for this study within 12.5 months.

Outcomes

Lymphatic drainage patterns as determined by peritumoral and subareolar injections
Identification rate of sentinel nodes and negative predictive value associated with subareolar injection

Outline

At least 2 days before scheduled surgery, patients receive technetium Tc 99m sulfur colloid by peritumoral injection followed by lymphoscintigraphy. Images are obtained at 30 minutes and after 2 and 3 hours, provided no drainage is noted. Patients then receive technetium Tc 99m sulfur colloid by subareolar injection followed by another lymphoscintigraphy.

At the time of surgery, patients receive isosulfan blue by subareolar injection. A handheld gamma probe is used to locate the sentinel node. If the sentinel node is identified, it is excised and the scheduled breast surgery is performed. If the sentinel node cannot be identified, patients undergo the scheduled breast surgery.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Gildy Babiera, MD, Protocol chair		Ph: 713-745-1563; 800-392-1611
Ebrahim Delpassand, MD, Protocol co-chair(Contact information may not be current)		Ph: 713-792-6161; 800-392-1611

Registry Information
Official Title		A Preliminary Study To Explore Subareolar Injection As The Site For Lymphatic Mapping And Sentinel Lymph Node Biopsy In Patients With Breast Cancer
Trial Start Date		2005-06-09
Registered in ClinicalTrials.gov		NCT00438477
Date Submitted to PDQ		2004-02-09
Information Last Verified		2007-07-26
NCI Grant/Contract Number		CA16672