Contrast Ultrasound Detection of Sentinel Lymph Nodes
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
This is a two part, open label, non-randomized trial of women with a breast cancer diagnosis
scheduled for excisional surgery and sentinel lymph node (SLN) evaluation.
Part 1 is a two-period, crossover, dose-finding study, which will be performed in 12 healthy
female volunteers to determine the optimal dose as well as the safety and tolerability of the
tissue-specific, contrast agent Sonazoid (GE Healthcare, Oslo, Norway) for human lymphatic
applications. In Part 2 lymphosonographic SLN identification will be compared to that of
isotope mapping during surgery on 90 female, breast cancer patients.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University Thomas Jefferson University
Collaborators:
GE Healthcare National Cancer Institute (NCI) Siemens Medical Solutions