Dynamics and Tracer Distribution of Tilmanocept in Early Stage Breast Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer, Sentinel Lymph Node

Intervention / Treatment
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* Drug: Tilmanocept
* Drug: Nanocolloid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Injection of 99m-Tc Tilmanocept<br> | Drug: Tilmanocept<br>* Combined peri-areolar and peri-tumoral injection of 99m-Tc Tilmanocept<br>|
| Active Comparator: Injection of 99m-Tc Nanocolloid<br> | Drug: Nanocolloid<br>* Combined peri-areolar and peri-tumoral injection of 99m-Tc Nanocolloid<br>* Other names: Nanoscint;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 20 to 24 hours post-injection |