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| Name | Class |
|---|---|
| Norgine | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Injection of 99m-Tc Tilmanocept | Active Comparator |
| |
| Injection of 99m-Tc Nanocolloid | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tilmanocept | Drug | Combined peri-areolar and peri-tumoral injection of 99m-Tc Tilmanocept |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| university hospital, Ghent | Ghent | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24085499 | Background | 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. | |
| 28695567 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C083602 | technetium Tc 99m nanocolloid |
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| Nanocolloid | Drug | Combined peri-areolar and peri-tumoral injection of 99m-Tc Nanocolloid |
|
|
| Background |
| 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. |
| 29498443 | Background | 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. |
| D017437 |
| Skin and Connective Tissue Diseases |