NCT04487912

Dynamics and Tracer Distribution of Tilmanocept in Early Stage Breast Cancer

Dynamics and Tracer Distribution of Tilmanocept Using Combined Subareolar and Peritumoral Injection Technique for Scintigraphic Sentinel Lymph Node Detection in Early Stage Breast Cancer

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A sentinel node procedure is recommended for patients with early stages of breast cancer to exclude metastases to local lymph nodes. This procedure is done with a "tracer" which is injected near to the tumor and drains to these nearby lymph nodes. The first draining lymph node(s) are called "sentinel" node(s). These sentinel nodes are excised by the surgeon for microscopic investigation using a detection probe. This study aims to further document the distribution and dynamics of a recently approved new tracer called Tilmanocept and comparing it with the standard used tracer (nanocolloid) to determine whether there is a significant difference between both products (which are both approved for clinical use in this scenario in the European Union). This will be done by randomly assigning patients between injection of Tilmanocept or Nanocolloid and making scans on multiple (3) time points.

Conditions

• Breast Cancer
• Sentinel Lymph Node

Interventions

Type	Name	Description
DRUG	Tilmanocept	Combined peri-areolar and peri-tumoral injection of 99m-Tc Tilmanocept
DRUG	Nanocolloid	Combined peri-areolar and peri-tumoral injection of 99m-Tc Nanocolloid

Timeline

• Start date: 2020-11-24
• Primary completion: 2021-05-01
• Completion: 2021-05-01
• First posted: 2020-07-27
• Last updated: 2021-05-14

Locations

1 site across 1 country: Belgium