Sentinel Lymph Node Identification in the Axilla of Women With Breast Cancer Using Ultrasound and Iron Injection

• Status: Withdrawn
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study evaluates a new method of testing the lymph nodes in the armpit of patients with breast cancer for tumor involvement. All participants involved in this study will undergo an injection of a small amount of iron dissolved in liquid followed by an ultrasound of the axilla that will make previously invisible lymph nodes visible, allowing them to be sampled in an outpatient setting.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Treatments: Iron

Criteria

Inclusion Criteria:

• Female patients at least 21 years old

• Patients with invasive ductal carcinoma staged T1 or T2 with estrogen receptor and progesterone receptor positive (ER+/PR+) who are scheduled for sentinel lymph node biopsy

• Patients with Ductal Carcinoma In Situ (DCIS) (high or low grade) who are scheduled for sentinel lymph node biopsy including:

• Patients having a mastectomy

• Patients with palpable DCIS

• Patients undergoing breast conservation with large (>5cm) area of DCIS

• Patients with signed consent to participate

Exclusion Criteria:

• Preoperative palpable axillary lymphadenopathy

• Preoperative ultrasound demonstrating suspicious adenopathy

• Previous axillary dissection or previous lymph node biopsy

• Patients with Invasive Lobular Carcinoma

• Patients who are pregnant