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

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 Overview

• Status: Withdrawn
• Conditions: Breast Cancer; Sentinel Lymph Node
• Intervention / Treatment: Drug: Tilmanocept; Drug: Nanocolloid

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium
    • University Hospital, Ghent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Injection of 99m-Tc Tilmanocept	Drug: Tilmanocept; Combined peri-areolar and peri-tumoral injection of 99m-Tc Tilmanocept
Active Comparator: Injection of 99m-Tc Nanocolloid	Drug: Nanocolloid; Combined peri-areolar and peri-tumoral injection of 99m-Tc Nanocolloid; Other Names: Nanoscint

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: Norgine

Publications and helpful links

General Publications

• Giammarile F, Alazraki N, Aarsvold JN, Audisio RA, Glass E, Grant SF, Kunikowska J, Leidenius M, Moncayo VM, Uren RF, Oyen WJ, Valdes Olmos RA, Vidal Sicart S. The EANM and SNMMI practice guideline for lymphoscintigraphy and sentinel node localization in breast cancer. Eur J Nucl Med Mol Imaging. 2013 Dec;40(12):1932-47. doi: 10.1007/s00259-013-2544-2. Epub 2013 Oct 2.
• Unkart JT, Hosseini A, Wallace AM. Tc-99m tilmanocept versus Tc-99m sulfur colloid in breast cancer sentinel lymph node identification: Results from a randomized, blinded clinical trial. J Surg Oncol. 2017 Dec;116(7):819-823. doi: 10.1002/jso.24735. Epub 2017 Jul 10.
• Unkart JT, Proudfoot J, Wallace AM. Outcomes of "one-day" vs "two-day" injection protocols using Tc-99m tilmanocept for sentinel lymph node biopsy in breast cancer. Breast J. 2018 Jul;24(4):526-530. doi: 10.1111/tbj.13002. Epub 2018 Mar 2.

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2020
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: July 22, 2020
• First Submitted That Met QC Criteria: July 24, 2020
• First Posted (Actual): July 27, 2020

Study Record Updates

• Last Update Posted (Actual): May 14, 2021
• Last Update Submitted That Met QC Criteria: May 12, 2021
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: AGO/2019/003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No