Feasibility of the LUM Imaging System for Detection of Primary Pancreatic Cancer and Peritoneal Invasion From Primary Pancreatic Cancer During Surgery

This single-site, non-randomized, open-label study to assess the initial safety and efficacy of the LUM Imaging System for detection of primary pancreatic cancer and peritoneal invasion from primary pancreatic cancer during surgery. In this feasibility study, the tumor detection algorithm will be developed for this indication.

开始日期2026-01-01

申办/合作机构

Lumicell, Inc.

NCT04440982 / Terminated临床2期

Feasibility Study to Evaluate Performance of the LUM Imaging System for Intraoperative Detection of Residual Tumor in Breast Cancer Patients Receiving and Not Receiving Neoadjuvant Therapy

This is a prospective, multi-center, randomized, clinical trial evaluating patients undergoing breast conserving surgery using the LUM Imaging System.

开始日期2020-09-01

申办/合作机构

Lumicell, Inc.

[+2]

NCT03686215 / Completed临床3期

Pivotal Study of the LUM Imaging System for Assisting Intraoperative Detection of Residual Cancer in the Tumor Bed of Female Patients With Breast Cancer

This is a multi-center, two-arm randomized, blinded pivotal study to demonstrate the safety and efficacy of the LUM Imaging System (LUM015 imaging agent in conjunction with the LUM Imaging Device and decision software), in identifying residual cancer in the lumpectomy bed of female breast cancer patients undergoing breast surgery in order to assist surgeons in reducing the rates of positive margins.
All enrolled subjects will be injected with LUM015 prior to surgery. Surgeons are blinded to whether a participant will be randomized into the device arm until after the standard of care lumpectomy is complete. Participants will then be randomized to receiving the device. Therapeutic (LUM guided) shaves will be removed based on the guidance of the LUM Imaging System. Patients will be followed until their first standard of care post-operative follow-up visit.

开始日期2019-11-04

申办/合作机构

Lumicell, Inc.

[+1]

100 项与 Pegulicianine 相关的临床结果

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100 项与 Pegulicianine 相关的转化医学

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100 项与 Pegulicianine 相关的专利（医药）

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项与 Pegulicianine 相关的文献（医药）

2023-06-27·NEJM Evidence

Intraoperative Fluorescence Guidance for Breast Cancer Lumpectomy Surgery

Article

作者: Smith, Kate Porta ; Dodge, Daleela ; Dyess, Donna L. ; Clark, Patricia ; Wapnir, Irene L. ; Harris, Daniel K. ; Carr, David ; Gadd, Michele A. ; Lesnikoski, Beth-Anne ; Hunt, Kelly K. ; Samiian, Laila ; Stone, Kimberly ; Chang, Manna ; Hwang, E. Shelley ; Dekhne, Nayana ; Ferrer, Jorge ; Smith, Barbara L. ; Clark, Lynne ; Schlossberg, Brian ; Lee, Marie Catherine ; Valente, Stephanie ; Blumencranz, Peter W.

BACKGROUND: Although lumpectomy and mastectomy provide equivalent survival for patients with breast cancer, local recurrence after lumpectomy increases breast cancer mortality. Positive lumpectomy margins, which imply incomplete tumor removal, are the strongest predictor of local recurrence and are identified days after surgery, necessitating a second surgery. METHODS: In this prospective trial, we assessed margin status with or without pegulicianine fluorescence-guided surgery (pFGS) for stages 0 to 3 breast cancers. To prevent surgeons from performing smaller than standard lumpectomies in anticipation of pFGS assistance, patients were randomly assigned 10:1 to pFGS or control groups, thus randomization was not designed to provide a control group for evaluating device performance. In patients undergoing pFGS, additional pFGS-guided cavity margins were excised at sites of pegulicianine signal. We evaluated three coprimary end points: the percentage of patients for whom pFGS-guided margins contained cancer, sensitivity, and specificity. RESULTS: Overall, 406 patients received 1.0 mg/kg intravenous pegulicianine followed by lumpectomy. Among 392 patients randomly assigned, 316 had invasive cancers, and 76 had in situ cancers. In 27 of 357 patients undergoing pFGS, pFGS-guided margins removed tumor left behind after standard lumpectomy, 22 from cavity orientations deemed negative on standard margin evaluation. Second surgeries were avoided by pFGS in 9 of 62 patients with positive margins. On per-margin analysis, pFGS specificity was 85.2%, and sensitivity was 49.3%. Pegulicianine administration was stopped for adverse events in six patients. Two patients had grade 3 serious adverse events related to pegulicianine. CONCLUSIONS: The use of pFGS in breast cancer surgery met prespecified thresholds for removal of residual tumor and specificity but did not meet the prespecified threshold for sensitivity. (Funded by Lumicell, Inc. and the National Institutes of Health; Clinicaltrials.gov number, NCT03686215.)

2023-06-27·NEJM Evidence

Something to Dye For: Toward Better Breast Lumpectomy Margins

作者: Turza, Lauren C. ; Shriver, Craig D.

The development of fluorescence imaging in oncology led to the possibility of using intraoperative devices to improve the precision of surgical techniques.¹ In this issue of NEJM Evidence, Smith et al.² report results from a prospective multicenter trial evaluating the ability of intravenous pegulicianine with an optical head device and software to intraoperatively identify lumpectomy margins with residual cancer and excise them immediately. Identifying these margins intraoperatively avoids the need for a second surgery, which is required when margins are positive on the final pathology.

2022-07-01·JAMA Surgery

A Nonrandomized Controlled Trial

Article

作者: Chagpar, Anees ; Dekhne, Nayana ; Lesnikoski, Beth-Ann ; Chang, Manna ; Dodge, Daleela ; Smith, Kate ; Strasfeld, David ; Blumencranz, Peter ; Smith, Barbara L. ; Hunt, Kelly ; Beitsch, Peter ; Harris, Daniel K ; Gold, Linsey ; Lee, David ; Carr, David ; Clark, Lynne ; Grobmyer, Stephen ; Dyess, Donna L. ; Karp, Stephen ; Wapnir, Irene ; Ferrer, Jorge ; Madden, Sean ; Hwang, E. Shelley ; Schlossberg, Brian

ImportancePositive margins following breast-conserving surgery (BCS) are often identified on standard pathology evaluation. Intraoperative assessment of the lumpectomy cavity has the potential to reduce residual disease or reexcision rate following standard of care BCS in real time.ObjectiveTo collect safety and initial efficacy data on the novel pegulicianine fluorescence-guided system (pFGS) when used to identify residual cancer in the tumor bed of female patients undergoing BCS.Design, Setting, and ParticipantsThis prospective single-arm open-label study was conducted as a nonrandomized multicenter controlled trial at 16 academic or community breast centers across the US. Female patients 18 years and older with newly diagnosed primary invasive breast cancer or ductal carcinoma in situ DCIS undergoing BCS were included, excluding those with previous breast cancer surgery and a history of dye allergies. Of 283 consecutive eligible patients recruited, 234 received a pegulicianine injection and were included in the safety analysis; of these, 230 were included in the efficacy analysis. Patients were enrolled between February 6, 2018, and April 10, 2020, and monitored for a 30-day follow-up period. Data were analyzed from April 10, 2020, to August 5, 2021.InterventionsParticipants received an injection of a novel imaging agent (pegulicianine) a mean (SD) of 3.2 (0.9) hours prior to surgery at a dose of 1 mg/kg. After completing standard of care (SOC) excision, pFGS was used to scan the lumpectomy cavity to guide the removal of additional shave margins.Main Outcomes and MeasuresAdverse events and sensitivity, specificity, and reexcision rate.ResultsOf 234 female patients enrolled (median [IQR] age, 62.0 [55.0-69.0] years), 230 completed the trial and 1 patient with a history of allergy to contrast agents had an anaphylactic reaction and recovered without sequelae. Correlation of pFGS with final margin status on a per-margin analysis showed a marked improvement in sensitivity over standard pathology assessment of the main lumpectomy specimen (69.4% vs 38.2%, respectively). On a per-patient level, the false-negative rate of pFGS was 23.7% (9 of 38), and sensitivity was 76.3% (29 of 38). Among 32 patients who underwent excision of pFGS-guided shaves, pFGS averted the need for reexcision in 6 (19%).Conclusions and RelevanceIn this pilot feasibility study, the safety profile of pegulicianine was consistent with other imaging agents used in BCS, and was associated with a reduced need for second surgery in patients who underwent intraoperative additional excision of pFGS-guided shaves. These findings support further development and clinical performance assessment of pFGS in a prospective randomized trial.Trial RegistrationClinicalTrials.gov Identifier: NCT03321929.

项与 Pegulicianine 相关的新闻（医药）

2024-10-11

·药精通Bio

2024 FDA已批准34款新药！其中Q3新增13款！

OTC2024类器官前沿应用与3D细胞培养论坛圆满落幕，点击图片可查看会后报告，咨询OTC2025类器官论坛请联系：王晨 180 1628 8769 🧴Berdazimer （Zelsuvmi），一种用于治疗局部传染性软疣的一氧化氮（NO）释放剂。💉头孢吡肟/恩美唑巴坦（Exblifep），一种包含头孢吡肟和恩美唑巴坦的固定剂量组合，用于治疗尿路感染。 💉LetibotulinumtoxinA （Letybo），一种纯化的 A 型肉毒杆菌神经毒素蛋白复合物，用于改善眉间纹的外观。💉替雷利珠单抗（Tivembra）是一种 IgG4 变体 PD-1 mAb，适用于治疗不可切除、局部晚期或转移性食管鳞状细胞癌。💊Resmetirom （Rezdiffra），一种甲状腺激素受体 β （NR1A2）激动剂用于治疗非肝硬化性非酒精性脂肪性肝炎。 💊Aprocitentan （Tryvio），一种用于治疗高血压的内皮素受体拮抗剂。💊Givinostat （Duvyzat），一种组蛋白脱乙酰酶抑制剂，用于治疗杜氏肌营养不良症。💉 Sotatercept （Winrevair），一种用于治疗肺动脉高压的激活素信号抑制剂。💊 Vadadustat （Vafseo），一种口服缺氧诱导因子脯氨酰羟化酶抑制剂，用于治疗成人与 CKD 相关的症状性贫血。💊 Danicopan （Voydeya），补体因子 D 抑制剂，用于治疗 PNH 患者的血管外溶血。 💉 Ceftobiprole medocaril （Zevtera）是一种广谱头孢菌素抗菌剂，适用于某些类型的肺炎、菌血症和皮肤感染。💉 Pegulicianine （Lumisight），一种用于乳腺癌荧光成像的光学成像剂。💉 Nogapendekin alfa inbakicept （Anktiva）是一种白细胞介素 15 受体激动剂与卡介苗（BCG）的组合，用于治疗膀胱癌。 💊 Tovorafenib （Ojemda），一种 II 型 RAF 激酶抑制剂，用于治疗具有 BRAF 基因突变的小儿低级别胶质瘤。💊 Mavorixafor （Xolremdi），一种用于治疗 WHIM 综合征的 CXCR4 拮抗剂。💉 Tarlatamab （Imdelltra）是一种靶向 DLL3 和 CD3 的双特异性单克隆抗体和 T 细胞接合器，用于治疗广泛期小细胞肺癌。💉 Imetelstat （Rytelo），一种寡核苷酸端粒酶抑制剂，用于治疗骨髓增生异常综合征伴输血依赖性贫血。 💊 Elafibranor （Iqirvo），一种双重 PPARα/δ 激动剂，用于治疗原发性胆汁性胆管炎。🧴Sofpironium （Sofdra），一种用于治疗多汗症的 M3 毒蕈碱受体抑制剂。💉 Crovalimab （Piasky），一种用于治疗阵发性睡眠性血红蛋白尿症的补体 C5 抑制性 mAb。🫁 Ensifentrine，一种用于治疗 COPD 的双重 PDE3/4 抑制剂。💉Donanemab-azbt，一样β淀粉样蛋白（Aβ）定向抗体，用于治疗阿尔兹海默病。💊Deuruxolitinib，一种JAK1和JAK2抑制剂，用于治疗严重斑秃。💊Vorasidenib，一种 IDH1 和 IDH2 抑制剂，用于治疗具有易感 IDH1 或 IDH2 突变的 2 级星形细胞瘤或少突胶质细胞瘤。💉Palopegteriparatide，一种用于治疗甲状旁腺功能亢进症的甲状旁腺激素类似物。💉Nemolizumab，一种用于治疗结节性痒疹的 IL-31 受体 α 拮抗剂。 💊Seladelpar 是一种 PPAR-δ 激动剂，用于单独治疗原发性胆汁性胆管炎或与熊去氧胆酸联合治疗。💉Axatilimab 是一种 CSF-1R mAb，用于降低慢性移植物抗宿主病患者的致病性巨噬细胞活性。💊Lazertinib，一种 EGFRm 激酶抑制剂，与 amivantamab 联合用于治疗具有 EGFR 突变的非小细胞肺癌。💉Lebrikizumab，一种抗 IL-13 的 IgG4 mAb，用于治疗中度至重度特应性皮炎。💊Arimoclomol 是一种热休克蛋白共诱导剂，用于与 miglustat 联合治疗 C 型尼曼-匹克病的神经系统症状。💊L-乙酰亮氨酸，亮氨酸的一种改良形式，用于治疗 C 型尼曼-匹克病患者的神经系统症状。💊Xanomeline 和 trospium chloride，联合双重 M 1 - 和 M 4 - 选择性毒蕈碱受体激动剂和毒蕈碱受体拮抗剂，用于治疗精神分裂症。 💉Flurpiridaz F-18，一种用于评估心肌缺血和梗死的放射性诊断药物Picture from Chris De Savi 文章来源：早研早聊参考素材：素材来源官方媒体/网络新闻 END 免责声明：本文仅作知识交流与分享及科普目的，不涉及商业宣传，不作为相关医疗指导或用药建议。文章如有侵权请联系删除。 OTC2024类器官前沿应用与3D细胞培养论坛圆满落幕，点击图片可查看会后报告，咨询OTC2025类器官论坛请联系：王晨 180 1628 8769

上市批准

2024-09-05

·Business Wire

CMS Grants Transitional Pass-Through Payment for LUMISIGHT™ (pegulicianine) and Increases Access for Patients with Breast Cancer

NEWTON, Mass.--( BUSINESS WIRE )-- Lumicell, Inc ., a privately held company focused on developing innovative fluorescence-guided imaging technologies for cancerous tissue detection during surgery, today announced that the Centers for Medicare & Medicaid Services (CMS) has approved its application for transitional pass-through (TPT) status for LUMISIGHT™ (pegulicianine) under the Medicare hospital outpatient prospective payment system (OPPS). The new Healthcare Common Procedure Coding System (HCPCS) drug TPT code (C9171 Injection, pegulicianine, 1 mg) may be used to bill CMS for LUMISIGHT when it is used in the treatment of Medicare beneficiaries in the hospital outpatient setting starting October 1, 2024. The TPT payment is a mechanism created by the CMS to increase patient access to new and truly innovative technologies, such as LUMISIGHT, by facilitating adequate payment of new technologies. TPT will provide additional Medicare payment for LUMISIGHT for 2 to 3 years, and during this time, Medicare will collect and assess the data in consideration of future payments. “We are proud that the country's largest payer for health care recognizes the importance of our truly innovative fluorescence-guided imaging technology," said Howard Hechler, President and COO, “enhancing patient access to LUMISIGHT while helping surgeons to find cancer that might otherwise go undetected.” Up to 36% of patients with breast cancer have follow-up surgeries due to positive margins and 14% of patients with negative margins after lumpectomy have cancer remaining according to clinical studies. 1 When LUMISIGHT is used with Lumicell DVS during lumpectomy, together referred to as LumiSystem™, surgeons can detect and resect residual breast cancer with 84% diagnostic accuracy as an adjunct to the procedure. 2 LUMISIGHT (pegulicianine) received FDA approval in April of 2024 and will be commercially available in Q4 of this year. About Lumicell Inc. Lumicell is a privately held company focused on enabling a more complete resection of cancer by advancing the development and commercialization of its innovative fluorescence guided surgery technology. The company’s lead products are LUMISIGHT™ (pegulicianine) and Lumicell™ DVS which are designed for use in combination to illuminate cancerous tissue within the breast cavity during the initial lumpectomy procedure, as an adjunct to the standard of care. Lumicell’s proprietary, pan-oncologic optical imaging agent, LUMISIGHT, is also being explored for further development across a wide variety of solid tumor indications. For more information, please visit www.Lumicell.com and follow the company on Facebook , X , and LinkedIn . Indications for Use LUMISIGHT, an optical imaging agent, and Lumicell DVS, a fluorescence imaging device, are indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery. Important Safety Information What is LUMISIGHT (pegulicianine) and Lumicell DVS? LUMISIGHT (pegulicianine), an optical fluorescence imaging agent, and Lumicell DVS, an imaging device, are used in adults with breast cancer to help detect any remaining cancerous tissue at the surgical site following removal of the primary specimen during a lumpectomy procedure. What is the most important information I should know about LUMISIGHT? Hypersensitivity Reactions: LUMISIGHT may cause serious hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred in 4/726 (0.6%) of patients in clinical studies. Tell your doctor if you have any history of hypersensitivity reactions to pegulicianine or to contrast media or products containing polyethylene glycol (PEG). Your healthcare provider should have emergency resuscitation drugs, equipment, and trained personnel available during use of LUMISIGHT. Healthcare providers should monitor all patients for hypersensitivity reactions and if one is suspected, immediately discontinue the injection and initiate appropriate therapy. What are the most common side effects of LUMISIGHT? The most common side effects (≥1%) include hypersensitivity and an abnormal color in urine. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088. Please see full Prescribing Information , including Boxed Warning. What additional important information I should know about LUMISIGHT and Lumicell DVS? Adjunctive use : Lumicell DVS is for use as part of the lumpectomy procedure and is not a replacement for the standard of care procedures and pathology. Your healthcare provider must be trained on proper use of the Lumicell DVS, and breast conserving surgery prior to performing any procedures. Risk of Misdiagnosis: The absence of a signal in surgery does not rule out cancer. Additionally, a positive signal may be seen in non-cancerous tissue. Interference from Dyes Used for Sentinel Lymph Node Mapping: Your healthcare provider should avoid use of dyes before imaging the lumpectomy cavity who have received LUMISIGHT. Tissue perforation or damage : During the procedure, your healthcare provider should avoid excessive pressure or torque with the Lumicell DVS handheld probe while inside the cavity as it can cause tissue perforation or damage. Infection risk : To avoid infection risk, the reusable Lumicell DVS handheld probe and cables should be properly and completely disinfected and reprocessed after each use by your healthcare provider. Your healthcare provider should also ensure proper use of the sterile, single-use probe cover. Eye discomfort : Your healthcare provider should avoid direct eye exposure to Lumicell DVS handheld light probe as it may cause pain. Please see the LUMISIGHT Prescribing Information , including Boxed Warning, and Lumicell DVS Instructions for Use . For complete product information, visit www.LumiSystem.com . 1 Dupont, et al., Ann Surg 2021; 273(5): 876-881 2 Smith, et al., NEJM Evidence 2023; 2(7) MKT00267rA

上市批准

2024-07-15

·Business Wire

Lumicell Announces New Category III CPT® Code for Intraoperative Fluorescence Imaging Margin Assessment in Support of Market Launch

NEWTON, Mass.--( BUSINESS WIRE )-- Lumicell, Inc ., a privately held company focused on developing innovative fluorescence-guided imaging technologies for cancerous tissue detection during surgery, today announced the American Medical Association has granted a Category III, Current Procedural Terminology (CPT) add-on code 0945T specifically for intraoperative fluorescence imaging margin assessment following breast cancer lumpectomy. 3 The new CPT code is expected to become effective on Jan. 1, 2025. The purpose of CPT coding is to provide a uniform language that accurately describes medical, diagnostic, and testing services for reliable nationwide communication among physicians and other healthcare providers, patients, and third parties such as payors. The granting of this add-on code will allow physicians to report their usage of LUMISIGHT™ and Lumicell™ DVS, together referred to as LumiSystem™, to help payors collect claims data for improved access. “This is an important milestone for providers who offer this new adjunctive treatment option to their patients with breast cancer undergoing lumpectomy,” said Howard Hechler, President and Chief Operating Officer, Lumicell. “The Category III code will enable wider commercial access to LumiSystem by facilitating future reimbursement from US government payors and commercial health insurance companies.” Clinical studies have shown that up to 36% of patients have re-excisions due to positive margins and 14% of patients with negative margins after lumpectomy have cancer remaining. 1 With 84% diagnostic accuracy, LumiSystem is the first and only system that enables surgeons to scan inside the breast cavity, in real-time, to detect and resect residual cancer that may have otherwise been left behind. 2 “This new CPT code demonstrates positive momentum towards improving patient access to LumiSystem, which will have significant impact on breast cancer surgical outcomes for patients,” said Peter Blumencranz, MD, Medical Director, BayCare Oncology Service Line and The Comprehensive Breast Care Center of Tampa Bay. LumiSystem will be commercially available in Q4 of this year. Please visit www.LumiSystem.com to learn more about LUMISIGHT and Lumicell DVS. About Lumicell Inc. Lumicell is a privately held company focused on enabling a more complete resection of cancer by advancing the development and commercialization of its innovative fluorescence guided surgery technology. The company’s lead products are LUMISIGHT™ (pegulicianine) and Lumicell™ DVS which are designed for use in combination to illuminate cancerous tissue within the breast cavity during the initial lumpectomy procedure, as an adjunct to the Standard of Care. Lumicell’s proprietary, pan-oncologic optical imaging agent, LUMISIGHT, is also being explored for further development across a wide variety of solid tumor indications. For more information, please visit www.Lumicell.com and follow the company on Facebook , X , and LinkedIn . Indications for Use LUMISIGHT, an optical imaging agent, and Lumicell DVS, a fluorescence imaging device, are indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery. Important Safety Information What is the most important information I should know about LUMISIGHT? LUMISIGHT may cause serious hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred in 4/726 (0.6%) of patients in clinical studies. Tell your doctor if you have any history of hypersensitivity reactions to pegulicianine or to contrast media or products containing polyethylene glycol (PEG). Your healthcare provider should have emergency resuscitation drugs, equipment, and trained personnel available during use of LUMISIGHT. Healthcare providers should monitor all patients for hypersensitivity reactions and if one is suspected, immediately discontinue the injection and initiate appropriate therapy. What other safety information should I know about LUMISIGHT? Risk of Misdiagnosis: The absence of a signal in surgery does not rule out cancer. Additionally, a positive signal may be seen in non-cancerous tissue. Interference from Dyes Used for Sentinel Lymph Node Mapping: Your healthcare provider should avoid using dyes before imaging with LUMISIGHT. What are the most common side effects of LUMISIGHT? The most common side effects (≥1%) include hypersensitivity and an abnormal color in urine. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088. Please see full Prescribing Information , including Boxed Warning. What is the most important information I should know about Lumicell DVS? Adjunctive use : Lumicell DVS is for use as part of the lumpectomy procedure and is not a replacement for the standard of care procedures and pathology. Your healthcare provider must be trained on proper use of the Lumicell DVS, and breast conserving surgery prior to performing any procedures. Risk of Misdiagnosis: The absence of a signal in surgery does not rule out cancer. Additionally, a positive signal may be seen in non-cancerous tissue. Interference from Dyes Used for Sentinel Lymph Node Mapping: Your healthcare provider should avoid using dyes before imaging with LUMISIGHT. Tissue perforation or damage : During the procedure, your healthcare provider should avoid excessive pressure or torque with the handheld probe while inside the cavity as it can cause tissue perforation or damage. Infection risk : To avoid infection risk, the reusable handheld probe and cables should be properly and completely disinfected and reprocessed after each use. Your healthcare provider should also ensure proper use of the sterile, single-use probe cover. Eye discomfort : Avoid direct eye exposure to handheld light probe as it may cause pain. Please see the LUMISIGHT Prescribing Information , including Boxed Warning, and Lumicell DVS Instructions for Use . For complete product information, visit www.LumiSystem.com . © 2024 Lumicell Inc. All Rights Reserved. MKT00246 1 Dupont, et al., Ann Surg 2021; 273(5): 876-881 2 Smith, et al., NEJM Evidence 2023; 2(7) 3 https://www.ama-assn.org/system/files/cpt-category3-codes-long-descriptors.pdf

100 项与 Pegulicianine 相关的药物交易

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适应症	国家/地区	公司	日期
乳腺癌	美国	Lumicell, Inc.	2024-04-17

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适应症	最高研发状态	国家/地区	公司	日期
脑转移瘤	临床2期	美国	Lumicell, Inc.	2019-05-03
胶质母细胞瘤	临床2期	美国	Lumicell, Inc.	2019-05-03
IDH1突变胶质瘤	临床2期	美国	Lumicell, Inc.	2019-05-03
低级神经胶质瘤	临床2期	美国	Lumicell, Inc.	2019-05-03
前列腺癌	临床2期	美国	Lumicell, Inc.	2019-03-20
腹膜癌	临床2期	美国	Lumicell, Inc.	2019-03-18
结直肠癌	临床2期	美国	Lumicell, Inc.	2016-08-04
食管癌	临床2期	美国	Lumicell, Inc.	2016-08-04
胰腺癌	临床2期	美国	Lumicell, Inc.	2016-08-04
胃癌	临床2期	美国	Lumicell, Inc.	2016-08-04

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03686215 (CL0007, FDA_CDER) 人工标引	临床3期	乳腺癌	357	LUMISIGHT	(鬱膚選淵觸鏇餘壓夢獵) = 網顧醖艱鑰獵鏇鏇蓋願膚廠鹹構蓋淵淵襯獵簾 (夢網網淵鏇壓艱鹽鏇壓, 5.0 ~ 10.8) 更多	积极	2024-04-17
NCT03686215 (pivotal study \| CL0007 \| INSITE, CTgov)	临床3期	乳腺癌	406	Study Device Arm (Device Intervention: LUM Imaging System Used During Surgery)	糧觸鬱淵夢鹹鑰衊襯觸(憲壓艱鬱蓋艱範鑰鹽築) = 餘繭積鏇簾簾鏇遞獵糧鏇網顧艱鑰網襯遞鏇築 (糧壓艱顧選艱衊顧獵淵, 蓋繭憲觸鹹淵網製齋簾 ~ 蓋鬱構選獵範廠衊窪選) 更多	-	2023-08-24
				LUM015 (Standard of Care Arm)	鹽簾鏇積憲廠鹹積鬱鹽(憲觸願艱顧構遞範簾網) = 艱壓鑰鹹顧糧鬱選鹹選網蓋壓膚顧淵齋餘壓鬱 (艱簾築獵艱夢遞糧壓觸, 選獵夢艱願築願製顧鏇 ~ 齋衊鹽網餘鬱觸淵膚鹹) 更多
NCT02438358 (CTgov)	临床1/2期	乳腺癌	60	LUM015 (Phase A No LUM015)	鬱膚窪鹽簾醖蓋憲餘遞(壓夢構鏇鑰淵鹹鹹願製) = 範遞夢簾壓襯顧淵遞範鏇積夢遞壓鏇壓餘窪遞 (鬱淵衊鏇醖糧觸觸鬱鏇, 選鹽遞蓋積製糧鬱衊糧 ~ 觸齋鏇積簾鏇簾衊觸鹽)	-	2023-01-05
				LUM015 (Phase A 0.5 mg/kg)	鬱膚窪鹽簾醖蓋憲餘遞(壓夢構鏇鑰淵鹹鹹願製) = 觸獵獵獵憲憲襯築鏇顧鏇積夢遞壓鏇壓餘窪遞 (鬱淵衊鏇醖糧觸觸鬱鏇, 餘築構獵遞選蓋願觸衊 ~ 獵壓膚網簾築膚膚齋鑰)
NCT01626066 (ASCO2014)	临床1期	肿瘤	9	LUM015 0.25 mg/kg	(襯廠鏇獵鏇積艱窪壓襯) = 鹹壓繭顧範餘鑰鏇醖壓艱淵壓簾範鏇遞築遞醖 (糧艱鬱製願襯膚醖壓鑰 )	-	2014-05-20
				LUM015 0.5 mg/kg	(襯廠鏇獵鏇積艱窪壓襯) = 醖膚顧膚廠積襯簾築鹹艱淵壓簾範鏇遞築遞醖 (糧艱鬱製願襯膚醖壓鑰 )