NCT04487912

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2020

Shorter than P25 for phase_4 breast-cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 27, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

November 24, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

May 14, 2021

Status Verified

June 1, 2020

Enrollment Period

5 months

First QC Date

July 22, 2020

Last Update Submit

May 12, 2021

Conditions

Breast CancerSentinel Lymph Node

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (2)

Injection of 99m-Tc Tilmanocept

ACTIVE COMPARATOR
Drug: Tilmanocept

Injection of 99m-Tc Nanocolloid

ACTIVE COMPARATOR
Drug: Nanocolloid

Interventions

TilmanoceptDRUG

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

Injection of 99m-Tc Tilmanocept
NanocolloidDRUG

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

Also known as: Nanoscint
Injection of 99m-Tc Nanocolloid

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Early stage breast cancer (T1, T2)
  • Clinically node negative (no enlarged axillary lymph nodes)

You may not qualify if:

  • Prior surgery in same breast
  • Pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

university hospital, Ghent

Ghent, Belgium

Location

Related Publications (3)

  • 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.

    PMID: 24085499BACKGROUND

  • 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.

    PMID: 28695567BACKGROUND

  • 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.

    PMID: 29498443BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

technetium Tc 99m nanocolloid

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2020

First Posted

July 27, 2020

Study Start

November 24, 2020

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

May 14, 2021

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)