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Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04487912

Enrollment

Registered

2020-07-27

Start date

2020-11-24

Completion date

2021-05-01

Last updated

2021-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Sentinel Lymph Node

Brief 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.

Interventions

DRUGTilmanocept

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

DRUGNanocolloid

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Time to identification of first lymph node	0-30 minutes	Time to identification of first lymph node on the dynamic acquisition during the first 30 minutes post-injection
Lymph node count to background ratio 4 hours post-injection	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
Lymph node count to background ratio 24 hours post-injection	20 to 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
Injection site count to background ratio 4 hours post-injection	4 hours post-injection	Count-to-background ratio in the radionuclide injection sites obtained by SPECT/CT 4 hours post-injection
Injection site count to background ratio 24 hours post-injection	20 to 24 hours post-injection	Count-to-background ratio in the radionuclide injection sites obtained by SPECT/CT 24 hours post-injection

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026