Comparative Evaluation of [99mTc]Tilmanocept for Sentinel Lymph Node Mapping in Breast Cancer Patients: Results of Two Phase 3 Trials
Autor: | Linda K. Han, Mark B. Faries, Charles E. Cox, Kenneth B. Deck, Anne M. Wallace, David R. Vera, Dennis King, Eli Avisar, Helen Krontiras, Lori Christman, Schlomo Schneebaum, Carl K. Hoh, Nathan Hall, Thomas G. Frazier, Stephen P. Povoski, Karl K. Limmer |
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Jazyk: | angličtina |
Předmět: |
Adult
medicine.medical_specialty Sentinel lymph node Oncology and Carcinogenesis Breast Neoplasms and over Breast Oncology Comparative evaluation Mannans Breast cancer Surgical oncology 80 and over Medicine Humans Oncology & Carcinogenesis Radionuclide Imaging Coloring Agents Aged Aged 80 and over business.industry Sentinel Lymph Node Biopsy Axillary Lymph Node Dissection Dextrans Middle Aged medicine.disease Surgery Clinical trial Sentinel lymph node mapping Axilla medicine.anatomical_structure Oncology Lymphatic Metastasis Technetium Tc 99m Pentetate Female Radiology Lymph Nodes Radiopharmaceuticals business |
Zdroj: | Annals of surgical oncology, vol 20, iss 8 Annals of Surgical Oncology |
ISSN: | 1068-9265 |
DOI: | 10.1245/s10434-013-2887-8 |
Popis: | BackgroundSentinel lymph node (SLN) surgery is used worldwide for staging breast cancer patients and helps limit axillary lymph node dissection. [(99m)Tc]Tilmanocept is a novel receptor-targeted radiopharmaceutical evaluated in 2 open-label, nonrandomized, within-patient, phase 3 trials designed to assess the lymphatic mapping performance.MethodsA total of 13 centers contributed 148 patients with breast cancer. Each patient received [(99m)Tc]tilmanocept and vital blue dye (VBD). Lymph nodes identified intraoperatively as radioactive and/or blue stained were excised and histologically examined. The primary endpoint, concordance (lower boundary set point at 90 %), was the proportion of nodes detected by VBD and [(99m)Tc]tilmanocept.ResultsA total of 13 centers contributed 148 patients who were injected with both agents. Intraoperatively, 207 of 209 nodes detected by VBD were also detected by [(99m)Tc]tilmanocept for a concordance rate of 99.04 % (p |
Databáze: | OpenAIRE |
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