Dynamics and Tracer Distribution of Tilmanocept in Early Stage Breast Cancer

University Hospital, Ghent

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Conditions

Breast Cancer Sentinel Lymph Node

Interventions

TilmanoceptDRUG

Combined peri-areolar and peri-tumoral injection of 99m-Tc Tilmanocept

NanocolloidDRUG

Combined peri-areolar and peri-tumoral injection of 99m-Tc Nanocolloid

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

university hospital, Ghent

Ghent, Belgium

Outcomes

Primary Outcomes

Time to identification of first lymph node

Time to identification of first lymph node on the dynamic acquisition during the first 30 minutes post-injection

Time frame: 0-30 minutes

Lymph node count to background ratio 4 hours post-injection

Number of identified lymph nodes and count-to-background ratio in these identified lymph nodes obtained by SPECT/CT 4 hours post-injection

Time frame: 4 hours post-injection

Lymph node count to background ratio 24 hours post-injection

Number of identified lymph nodes and count-to-background ratio in these identified lymph nodes obtained by SPECT/CT 24 hours post-injection

Time frame: 20 to 24 hours post-injection

Injection site count to background ratio 4 hours post-injection

Count-to-background ratio in the radionuclide injection sites obtained by SPECT/CT 4 hours post-injection

Time frame: 4 hours post-injection

Injection site count to background ratio 24 hours post-injection

Count-to-background ratio in the radionuclide injection sites obtained by SPECT/CT 24 hours post-injection

Time frame: 20 to 24 hours post-injection

Data from ClinicalTrials.gov

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