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Dynamics and Tracer Distribution of Tilmanocept in Early Stage Breast Cancer

NCT04487912 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2021-05-14

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Norgine

    collaborator INDUSTRY

  • University Hospital, Ghent

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-24
Primary Completion
2021-05-01
Completion
2021-05-01

Countries

  • Belgium

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04487912 on ClinicalTrials.gov