Dynamics and Tracer Distribution of Tilmanocept in Early Stage Breast Cancer

Phase 4

Withdrawn

• Conditions: Breast Cancer; Sentinel Lymph Node
• Interventions: Drug: Tilmanocept; Drug: Nanocolloid

• Registration Number: NCT04487912
• Lead Sponsor: University Hospital, Ghent

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-06
• Study First Submitted: 2020-07-22
• Study First Submitted QC: 2020-07-24
• Study First Posted: 2020-07-27
• Study Start: 2020-11-24
• Primary Completion: 2021-05-01
• Study Completion: 2021-05-01
• Last Update Submitted: 2021-05-12
• Last Update Posted: 2021-05-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Injection of 99m-Tc Tilmanocept	Tilmanocept	-
Injection of 99m-Tc Nanocolloid	Nanocolloid	-

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

university hospital, Ghent; 🇧🇪 Gent, Belgium