Dynamics and Tracer Distribution of Tilmanocept in Early Stage Breast Cancer

Ghent University Hospital (UZ)

Status and phase: Withdrawn; Phase 4

Conditions: Sentinel Lymph Node; Breast Cancer

Treatments: Drug: Tilmanocept; Drug: Nanocolloid

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04487912

AGO/2019/003

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Early stage breast cancer (T1, T2)
• Clinically node negative (no enlarged axillary lymph nodes)

Exclusion criteria

• Prior surgery in same breast
• Pregnancy or breastfeeding

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Injection of 99m-Tc Tilmanocept

Active Comparator group

Treatment:

Drug: Tilmanocept

Injection of 99m-Tc Nanocolloid

Active Comparator group

Treatment:

Drug: Nanocolloid