Clinical trial NCT04487912: Dynamics and Tracer Distribution of Tilmanocept in Early Stage Breast Cancer
Official title: Dynamics and Tracer Distribution of Tilmanocept Using Combined Subareolar and Peritumoral Injection Technique for Scintigraphic Sentinel Lymph Node Detection in Early Stage Breast Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Breast Cancer
Sentinel Lymph Node
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Norgine
First posted: 2020-07-27
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to identification of first lymph node
timeFrame: 0-30 minutes
measure: Lymph node count to background ratio 4 hours post-injection
timeFrame: 4 hours post-injection
measure: Lymph node count to background ratio 24 hours post-injection
timeFrame: 20 to 24 hours post-injection
measure: Injection site count to background ratio 4 hours post-injection
timeFrame: 4 hours post-injection
measure: Injection site count to background ratio 24 hours post-injection
timeFrame: 20 to 24 hours post-injection
Secondary outcomes:
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: university hospital, Ghent
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.