Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient patient inclusion
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Sentinel Lymph Node | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nanocolloid | Drug | — | UNRESOLVED |
| Tilmanocept | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Injection of 99m-Tc Tilmanocept
- interventionNames
- Drug: Tilmanocept
- type
- ACTIVE_COMPARATOR
- label
- Injection of 99m-Tc Nanocolloid
- interventionNames
- Drug: Nanocolloid
Primary outcomes (5)
- measure
- Time to identification of first lymph node
- timeFrame
- 0-30 minutes
- description
- Time to identification of first lymph node on the dynamic acquisition during the first 30 minutes post-injection
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDGiammarile 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 24085499
- BACKGROUNDUnkart 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 28695567
- BACKGROUNDUnkart 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 29498443