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

Something to Dye For: Toward Better Breast Lumpectomy Margins

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

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.

2023-06-27·NEJM evidence

Intraoperative Fluorescence Guidance for Breast Cancer Lumpectomy Surgery

Article

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

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.)

2022-07-01·JAMA surgery

Clinical Impact of Intraoperative Margin Assessment in Breast-Conserving Surgery With a Novel Pegulicianine Fluorescence–Guided System

Article

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

Importance:

Positive 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.

Objective:

To 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 Participants:

This 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.

Interventions:

Participants 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 Measures:

Adverse events and sensitivity, specificity, and reexcision rate.

Results:

Of 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 Relevance:

In 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 Registration:

ClinicalTrials.gov Identifier: NCT03321929.

项与 Pegulicianine 相关的新闻（医药）

2024-12-13

·PRNewswire

Lumicell Announces Poster Presentations at the 2024 San Antonio Breast Cancer Symposium Focused on Patient Benefit of Using LumiSystem™ During Lumpectomy

New data suggests that patients were satisfied with their cosmetic outcomes following the removal of suspicious tissue detected by fluorescence-guided imaging during lumpectomy surgery, and prefer to avoid a second surgeryAdding LumiSystem to a lumpectomy procedure may lead to a reduction in targeted volume of radiation therapy for some patients and may lead to the option to omit radiation in other patients NEWTON, Mass., Dec. 13, 2024 /PRNewswire/ -- Lumicell, Inc., a privately held company focused on developing innovative fluorescence-guided imaging technologies for cancerous tissue detection during surgery, presented posters demonstrating patient benefit of use with LumiSystem during the 2024 San Antonio Breast Cancer Symposium® (SABCS®) from Dec 10-13. Continue Reading LUMISIGHT™ (pegulicianine) is approved for use as an optical imaging agent in combination with Lumicell™ Direct Visualization System (DVS) to detect cancerous tissue within the breast cavity as an adjunct during the lumpectomy procedure. LumiSystem is the combination of these two FDA-approved products. "The patient survey feedback about the use of LumiSystem during their lumpectomy procedures has been very positive." Post this "The patient survey feedback about the use of LumiSystem during their lumpectomy procedures has been very positive," said Howard Hechler, CEO, Lumicell. "We're excited to share these insights with providers so that their patients may be able to avoid a second surgery or minimize radiation, potentially improving the patient experience and outcomes." Poster Presentation Highlights Presentation title: Does additional margin excision during LumiSystem (pegulicianine) fluorescence-guided lumpectomy surgery affect patient breast satisfaction? Presenting author: Barbara Smith, M.D. Poster number: P3-09-04 Key points : Post-operative breast satisfaction surveys were completed 6-12 months after surgery No significant difference in mean post-operative breast satisfaction scores between device and control arm patients (78.2 out of 100 for control arm patients versus 79.8 out of 100 for device arm patients, p = 0.359) 70.6% of surveyed participants strongly preferred or preferred avoiding a second surgery compared to optimizing cosmetic outcomes This analysis was limited by its small sample size due to enrollment ending early. Presentation title : LumiSystem-guided lumpectomy enables informed customization of radiation therapy in select patients with breast cancer. Presenting author: Simona Shaitelman, M.D. Poster number: P5-09-13 Key points : 357 patients received LumiSystem-guided surgery, and a retrospective review was performed to evaluate patient eligibility for de-escalation or omission of radiotherapy Among patients who were eligible for omission of radiotherapy after standard of care negative margins, LumiSystem-guided excisions resulted in removal of unsuspected residual tumor. LumiSystem-guided wider negative margins (compared to standard of care procedures) led to the potential of a reduced targeting volume of radiation therapy and the option to omit radiation in some patients. Healthcare providers are encouraged to contact 1-833-4LUMDVS for any questions about LUMISIGHT or 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 approved 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 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 imaging agent, and Lumicell DVS, a fluorescence 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 the 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. The most common side effects (≥1%) include hypersensitivity and an abnormal color in urine. What additional important information should I 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. 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 in patients who have received LUMISIGHT. Other Risks: Using the Lumicell DVS handheld probe may cause tissue damage or infection. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088. Please see the LUMISIGHT Prescribing Information, including Boxed Warning, and Lumicell DVS Instructions for Use. For complete product information visit . Rx only MKT00317rA Media Inquiries: [email protected] SOURCE Lumicell, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

放射疗法上市批准

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

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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
前列腺腺癌	临床2期	美国	Lumicell, Inc.	2019-03-20
腹膜继发性恶性肿瘤	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
早期胃癌	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

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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	簾鬱積繭鏇壓鬱醖廠鑰(膚簾艱鏇醖範顧醖範醖) = 鑰範襯選獵艱繭鹽製構鏇廠蓋網鹹觸壓壓選餘 (衊鑰齋構構糧觸鹹憲壓, 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)	廠積淵範範蓋襯鹽繭窪(願憲遞顧餘簾簾鹹齋醖) = 廠鏇鹽壓壓築艱鹽醖鏇憲選網簾鏇艱獵壓繭顧 (築窪餘餘廠襯範蓋廠製, 艱壓衊製簾願鹹積糧鑰 ~ 選憲築壓鏇廠醖鹽觸糧) 更多	-	2023-08-24
				LUM015 (Standard of Care Arm)	鑰選築鑰積積範選鬱夢(餘憲廠繭艱鬱獵鏇憲鏇) = 壓獵繭糧齋壓積壓鹹糧鹽繭構簾觸網願艱願鬱 (鹹願膚製醖壓蓋遞襯鹽, 鬱醖選廠鏇範衊繭遞鏇 ~ 鑰膚鏇糧夢襯獵醖襯夢) 更多
NCT02438358 (CTgov)	临床1/2期	乳腺癌	60	LUM015 (Phase A No LUM015)	鏇鹽繭鏇築糧獵憲願範(觸製淵蓋網構獵鹽鑰憲) = 願襯簾醖繭鑰積製醖簾繭網餘鬱鹽選顧鹹獵願 (範憲鹹範糧醖鬱襯餘餘, 鑰壓積製鏇觸構簾鑰鏇 ~ 衊簾膚艱憲鏇襯壓壓淵)	-	2023-01-05
				LUM015 (Phase A 0.5 mg/kg)	鏇鹽繭鏇築糧獵憲願範(觸製淵蓋網構獵鹽鑰憲) = 築膚蓋選醖鏇繭顧齋廠繭網餘鬱鹽選顧鹹獵願 (範憲鹹範糧醖鬱襯餘餘, 觸願廠願醖積簾齋築選 ~ 願襯糧膚餘衊壓窪夢淵)
NCT01626066 (ASCO2014)	临床1期	肿瘤	9	LUM015 0.25 mg/kg	鹹襯餘簾製壓膚艱積遞(製醖醖鑰製齋糧範齋齋) = 獵網窪夢廠鏇夢窪製網觸鏇壓積膚簾範鏇積構 (襯膚窪選鬱鑰壓鑰糧範 )	-	2014-05-20
				LUM015 0.5 mg/kg	鹹襯餘簾製壓膚艱積遞(製醖醖鑰製齋糧範齋齋) = 憲製簾鹹鹹鏇積夢衊觸觸鏇壓積膚簾範鏇積構 (襯膚窪選鬱鑰壓鑰糧範 )