Dynamics and Tracer Distribution of Tilmanocept in Early Stage Breast Cancer
NCT ID: NCT04487912
Last Updated: 2021-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2020-11-24
2021-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
TRIPLE
Study Groups
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Injection of 99m-Tc Tilmanocept
Tilmanocept
Combined peri-areolar and peri-tumoral injection of 99m-Tc Tilmanocept
Injection of 99m-Tc Nanocolloid
Nanocolloid
Combined peri-areolar and peri-tumoral injection of 99m-Tc Nanocolloid
Interventions
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Tilmanocept
Combined peri-areolar and peri-tumoral injection of 99m-Tc Tilmanocept
Nanocolloid
Combined peri-areolar and peri-tumoral injection of 99m-Tc Nanocolloid
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinically node negative (no enlarged axillary lymph nodes)
Exclusion Criteria
* Pregnancy or breastfeeding
18 Years
FEMALE
No
Sponsors
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Norgine
INDUSTRY
University Hospital, Ghent
OTHER
Responsible Party
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Locations
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university hospital, Ghent
Ghent, , Belgium
Countries
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References
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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.
Other Identifiers
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AGO/2019/003
Identifier Type: -
Identifier Source: org_study_id
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