A Pilot Study of Near-Infrared Imaging Using the Novel Imaging Agent Cytalux for Adolescent Patients With Metastatic Osteosarcoma Undergoing Pulmonary Metastasectomy

Pediatric subjects aged 6-17 with biopsy confirmed cancer and imaging findings suspicious for pulmonary metastatic disease scheduled to undergo pulmonary metastasectomy via and open or minimally invasive approach.

开始日期2024-01-20

申办/合作机构

Ann & Robert H. Lurie Children's Hospital of Chicago

[+1]

NCT04941378 / Withdrawn临床1期

A Pilot, Single Dose, Open-Label Study of OTL38 Injection (OTL38) for Intra-Operative Imaging of Folate Receptor Positive Ovarian Cancer

The primary objective of the study is to compare the performance of different camera imaging systems in assessing the positive predictive values and sensitivity of OTL38 to detect folate positive ovarian cancer cancers using the gold standard of pathologic review.

开始日期2022-05-28

申办/合作机构

Abramson Cancer Center

NCT04241315 / Completed临床3期

A Phase 3, Randomized,Single Dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules

This is a phase 3, multi-center, single dose, open-label, exploratory study in suspected lung cancer patients scheduled to undergo endoscopic or thoracic surgery per CT/PET/MRI or other imaging based on standard of care. This study aims to assess the efficacy of OTL38 and Near Infrared Imaging (NIR) at identifying pulmonary nodules within the operating theater, and to assess the safety and tolerability of single intravenous doses of OTL38.

开始日期2020-03-26

申办/合作机构

On Target Laboratories LLC

[+1]

100 项与 Pafolacianine 相关的临床结果

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100 项与 Pafolacianine 相关的转化医学

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100 项与 Pafolacianine 相关的专利（医药）

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项与 Pafolacianine 相关的文献（医药）

2024-01-08·European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery

Preoperative predictors of successful tumor localization by intraoperative molecular imaging with pafolacianine in lung cancer to create predictive nomogram.

Article

作者: Patrick Bou-Samra ; Jonah Joffe ; Austin Chang ; Emily Guo ; Alix Segil ; Feredun Azari ; Gregory Kennedy ; Azra Din ; Wei-Ting Hwang ; Sunil Singhal

OBJECTIVES:

Intraoperative molecular imaging(IMI) uses cancer-targeted fluorescent probe to locate nodules. Pafolacianine is a FDA-approved fluorescent probe for lung cancer. However, it has a 8-12% false negative rate for localization. Our goal is to define preoperative predictors of tumour localization by IMI.

METHODS:

We performed a retrospective review of patients who underwent IMI using pafolacianine for lung lesions from June 2015 to August 2019. Candidate predictors including sex, age, body mass index, smoking history, tumour size, distance of tumour from surface, use of neoadjuvant therapy and positron emission tomography(PET) avidity were included. The outcome was fluorescence in vivo and comprehensively included those who were true or false positives negatives. Multiple imputation was used to handle the missing data. The final model was evaluated using the area under the receiver operating characteristic curve(AUROC).

RESULTS:

Three hundred nine patients were included in our study. The mean age was 64(SD 13) and 68% had a smoking history. The mean distance of the tumors from the pleural surface was 0.4 cm(SD 0.6). Smoking in pack-years(PY) and distance from pleura had an odds ratio(OR) of 0.99 [95% CI 0.98-0.99 p = 0.03] and 0.46 [95% CI: 0.27-0.78; p = 0.004], respectively. The final model had an AUROC of 0.68 and was used to create a nomogram that gives a probability of fluorescence in vivo.

CONCLUSIONS:

Primary tumors that are deeper from the pleural surface, especially in patients with a higher PY, are associated with a decreased likelihood of intraoperative localization. We identified a nomogram to predict the likelihood of tumour localization with IMI with pafolacianine.

2023-08-01·Thoracic surgery clinics

Intraoperative Molecular Imaging of Lung Cancer.

Review

作者: Lye-Yeng Wong ; Natalie S Lui

Intraoperative molecular imaging innovations have been propelled by the development of fluorescent contrast agents that specifically target tumor tissues and advanced camera systems that can detect the specified fluorescence. The most promising agent to date is OTL38, a targeted and near-infrared agent that was recently approved by the Food and Drug Administration for intraoperative imaging for lung cancer.

2023-03-11·European journal of nuclear medicine and molecular imaging

Prospective validation of tumor folate receptor expression density with the association of pafolacianine fluorescence during intraoperative molecular imaging-guided lung cancer resections.

Article

作者: Feredun Azari ; Kevin Zhang ; Gregory Kennedy ; Patrick Bou-Samra ; Ashley Chang ; Bilal Nadeem ; Austin Chang ; Aysuna Galandarova ; Arturan Ibrahimli ; Ziya Karimov ; Azra Din ; John Kucharczuk ; Jarrar Doraid ; Taine Pechet ; Edward Delikatny ; Sunil Singhal

PURPOSE:

Pafolacianine, a folate receptor alpha-targeted NIR tracer, has demonstrated clear efficacy in intraoperative molecular imaging-guided (IMI) lung cancer surgery. However, the selection of patients who would benefit from IMI remains challenging given the variability of fluorescence with patient-associated and histopathologic factors. Our goal in this study was to prospectively evaluate whether preoperative FRα/FRβ staining can predict pafolacianine-based fluorescence during real-time lung cancer resections.

METHODS:

This was a prospective study conducted between 2018 and 2022 that reviewed core biopsy and intraoperative data from patients with suspected lung cancer. A total of 196 patients were deemed eligible, of whom core biopsies were taken from 38 patients and assessed for FRα and FRβ expression by immunohistochemistry (IHC). All patients underwent infusion of pafolacianine 24 h prior to surgery. Intraoperative fluorescence images were captured with the VisionSense bandpass filter-enabled camera. All histopathologic assessments were performed by a board-certified thoracic pathologist.

RESULTS:

Of the 38 patients, 5 (13.1%) were found to have benign lesions (necrotizing granulomatous inflammation, lymphoid aggregates) and 1 had metastatic non-lung nodule. Thirty (81.5%) had malignant lesions, with the vast majority (23, 77.4%) being lung adenocarcinoma (7 (22.5%) SCC). None of the benign tumors (0/5, 0%) exhibited in vivo fluorescence (mean TBR of 1.72), while 95% of the malignant tumors fluoresced (mean TBR of 3.11 ± 0.31) compared to squamous cell carcinoma (1.89 ± 0.29) of the lung and sarcomatous lung metastasis (2.32 ± 0.09) (p < 0.01). The TBR was significantly higher in the malignant tumors (p = 0.009). The median FRα and FRβ staining intensities were both 1.5 for benign tumors, while the FRα and FRβ staining intensities were 3 and 2 for malignant tumors, respectively. Increased FRα expression was significantly associated with the presence of fluorescence (p = 0.01), CONCLUSION: This prospective study sought to determine whether preoperative FRα and FRβ expression on core biopsy IHC correlates with intraoperative fluorescence during pafolacianine-guided surgery. These results, although of small sample size, including limited non-adenocarcinoma cohort, suggest that performing FRα IHC on preoperative core biopsies of adenocarcinomas as compared to squamous cell carcinomas could provide low-cost, clinically useful information for optimal patient selection which should be further explored in advanced clinical trials.

项与 Pafolacianine 相关的新闻（医药）

2024-01-03

·PRNewswire

On Target Laboratories Names Scott Huennekens as Executive Chairperson of the Board

WEST LAFAYETTE, Ind., Jan. 3, 2024 /PRNewswire/ -- On Target Laboratories, Inc., a privately held biotechnology company developing intraoperative molecular imaging agents to target and illuminate cancer during surgery, today announced the appointment of Scott Huennekens as Executive Chairperson of the Board. Continue Reading Scott Huennekens, Executive Chairperson of the Board, On Target Laboratories A 30-year veteran in the healthcare technology industry, Huennekens has played a pivotal role in more than 20 MedTech companies, including CEO, chairperson, board member, entrepreneur, and investor, with market valuations totaling over $30B and impacting greater than 20 million patient lives. He currently serves on the board of directors for multiple venture backed start-ups. "We are thrilled to welcome Scott to On Target Laboratories as the Executive Chairperson of the Board," said Ben Lundgren, President and CEO of On Target Laboratories. "His extensive experience and leadership in the healthcare industry make him an invaluable addition to our team. Scott's history in introducing novel, transformative technology into healthcare is ideally suited for our aspirations for On Target Laboratories." Mr. Huennekens expressed his enthusiasm for joining On Target Laboratories, stating, "I am honored to be part of On Target Laboratories, a company at the forefront of intraoperative molecular imaging. The work being done here has the potential to transform cancer surgery and make a significant impact on patient outcomes. I look forward to working with the talented team at On Target Laboratories and contributing to the company's continued success." About On Target Laboratories, Inc. On Target Laboratories discovers and develops targeted intraoperative molecular imaging agents to illuminate cancer during surgery. Their molecular imaging technology, based on the pioneering work of Philip S. Low, PhD, Purdue University's Presidential Scholar for Drug Discovery and the Ralph C. Corley Distinguished Professor of Chemistry, is comprised of a near-infrared dye and a targeting molecule, or ligand, that binds to receptors overexpressed on cancer cells. The imaging agents illuminate the cancerous tissue, which may enable surgeons to detect more cancer that otherwise may have been left behind. CYTALUX, the company's first product, received FDA approval of a New Drug Application for ovarian cancer in November 2021 and a supplemental New Drug Application for lung cancer in December 2022. CYTALUX targets the folate receptors commonly found on many cancers, binds to the cancerous tissue, and illuminates under near-infrared light. A single dose of the agent is administered via intravenous infusion prior to surgery and assists surgeons in visually identifying additional cancerous tissue to be removed during the operation. For more information visit and . SOURCE On Target Laboratories, Inc.

上市批准高管变更

2023-10-30

·动脉网

【首发】海擘生物完成数千万元Pre A轮融资，普华资本独家投资

动脉网第一时间获悉，近日，浙江海擘生物科技有限公司（后简称“海擘生物”）宣布完成数千万元Pre-A轮融资。本轮融资由普华资本独家投资，将助力海擘生物在产品研发、临床试验、科研合作等方面高速发展。全球领先的创新一类新药作为中国近红外肿瘤靶向精准成像创新药物引领者，海擘生物研发的近红外低氧靶向造影剂NC527-X，已提交NMPA Pre-IND申请。目前已针对实体肿瘤铺设多条管线。2020年中国新发癌症患者数量约为460万人，预计2022年达480万人，到2025年新发患者人数达520万人，占全球新发患者数的26.9%。手术切除通常是实体肿瘤的首选治疗方案，是否能够完全切除肿瘤组织很大程度上影响患者术后生存周期和质量。目前虽然有多种方式可以实现肿瘤诊断和术前规划，但由于设备等的限制，尚无有效手段实时辅助医生判断肿瘤边缘，是否完全切除主要依靠主刀医生经验，存在切缘阳性的风险。近红外肿瘤靶向精准成像技术为手术医生提供了术中实时指引，便于医生观察，进一步提高患者手术成功率，拥有巨大的潜在市场空间。具体而言，与传统成像方式相比，近红外肿瘤荧光分子探针可用于肿瘤术中切除及早筛/早诊/复查，拥有术中实时成像、高精度靶向肿瘤、无辐射及副作用、特异度高、手术时间窗口长等特点。一项统计表明，即使在美国，阳性切缘的平均发生率也高达近9%，在部分癌种中甚至高达20-30%。2021年11月，全球首款近红外肿瘤靶向造影剂药物Cytalux获得FDA批准上市。Cytalux 是一种靶向叶酸受体的近红外肿瘤靶向造影剂，目前已获得卵巢癌和肺癌的NDA批证。根据美国医药零售商（CVS）产品目录，Cytalux的价格是$4465.50，折后价格为$2790.93。与Cytalux不同，海擘生物的NC527-X靶向肿瘤低氧通路可应用于基于所有实体瘤的术中成像。同时，临床优势明显——适用于所有实体肿瘤，包括Cytalux无法适用的叶酸受体低表达的恶性肿瘤，如前列腺癌等；与人血白蛋白高效结合，体内代谢优异，无副作用；高灵敏度，看清肿瘤边界，无假阴性；无血脑屏障限制，可用于脑转移病灶成像；药物的使用窗口期极宽，外科手术医生接纳度高；全自主知识产权的新分子实体，享有全球权益。海擘生物创始人兼CEO王伟卫博士表示：“海擘生物搭建了全实体瘤种适配的低氧通路技术平台，目前已提交了NC527-X的Pre-IND申请，预计在年内提交IND申请。NC527-X在临床前试验中表现出良好的药效和安全性，有望成为全瘤种术中成像的First-in-Class产品，填补近红外肿瘤靶向精准成像产品的国内甚至全球空缺。非常感谢本轮投资的普华资本，以及早期投资的夏尔巴投资、诺辉创投，我们将持续发力，争取早日让自主研发的近红外低氧靶向造影剂惠及肿瘤患者和早筛人群，铺开全实体瘤种管线。”普华资本投资副总裁竺宝琳表示：“海擘生物团队在荧光造影剂领域有多年积累，顺利攻克研发过程中出现的各种成药性问题，现已将产品进展至临床申报准备阶段，处于国内领先地位，潜在应用场景广泛。我们对即将到来的临床试验充满期待，也希望早日看到海擘生物未来丰富的全实体瘤种布局，造福肿瘤患者。“夏尔巴投资董事总经理施伊娜表示：“外科切除手术迄今仍是有望根治实体肿瘤的最有效方法。近红外荧光成像为术中导航提供了新的解决方法，并开启了外科手术精准识别的时代，成为迫切的临床需求。海擘生物基于创始人团队多年的科研成果转化而来，和其他肿瘤诊断产品相比，具有快速标记、实时成像、超高特异性和灵敏度的竞争优势，这一产品将显著缩短手术时间并改善病人预后。作为海擘的最早期投资人之一，我们期待公司产品早日上市，惠及广大患者群体。”诺辉创投合伙人李彦蓉表示：“目前白光/荧光内窥镜已日益广泛地用于微创肿瘤切除术，但市面上缺少一种能特异性靶向显色肿瘤的造影剂，以帮助手术大夫更好地实时定位和精准、完整地切除肿瘤病灶。由于术中阳性切缘难以判断，导致术后肿瘤复发率高。2021年底，FDA批准上市了全球第一款可特异性靶向显色肿瘤的近红外荧光造影剂CYTALUX，这是肿瘤手术史上划时代的突破。而我们很欣喜地看到，海擘生物自主创新开发的近红外肿瘤靶向荧光造影剂，在动物试验中已经展现了优于CYTALUX的显色性能。期待这款产品早日进入临床试验，率先填补国内市场的巨大空白，解决肿瘤手术的关键痛点。”关于普华资本普华资本创立于2004年，总部位于杭州，在北京、上海、深圳、英国伦敦均设有办公室，专注于前沿科技、新能源/新材料、医疗健康、消费文化四大领域的投资。凭借对产业的深刻理解和丰富的资本市场经验，普华确立了“资本+产业”双轮驱动策略，致力于投早、投新、投专、投成长，做创业创新的培育者、助跑者。目前，普华资本在管规模超250亿元人民币，持续投资支持了近500家创业企业发展，通过IPO等形式实现退出的超150家。历投项目包括字节跳动、中储国能、南微医学、百普赛斯、健耕医药、睿米手术机器人、艾美疫苗等。在中国创业投资各年度榜单中，普华资本曾获2022年荣获投中榜“TOP14"、融资中国榜"TOP16"、清科榜"TOP18"，浙江领军投资机构等。近期推荐声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。动脉网，未来医疗服务平台

临床申请

2023-09-14

·BioSpace

A Clearer Vision of Surgery: Stryker Releases its Next-Generation of Advanced Surgical Cameras

Stryker's 1788 camera platform brings enhanced technology to the operating room – including a wider color gamut, more vivid white light and new fluorescence imaging capabilities SAN JOSE, California, USA, Sept. 14, 2023 /PRNewswire/ -- Stryker (NYSE: SYK), one of the world's leading medical technology companies, today unveiled the next-generation of minimally invasive surgical cameras: the 1788 platform. The fully enhanced camera is set to advance surgery across multiple specialties. The all-in-one surgical camera platform offers a more vibrant image with balanced lighting, a wider color gamut and clearer delineation of fluorescence signals1. The platform is designed for improved visualization of blood flow and critical anatomy and has the ability to visualize multiple optical imaging agents – when it matters most. "When it comes to surgical outcomes, dependable imaging is one of the most critical factors. With the enhanced imaging capabilities of the 1788, surgeons have a complete surgical camera technology that provides consistent and vivid imaging," said Dr. Matthew Albert, colon and rectal surgeon at Advent Health. "Patients deserve high-quality care, and we're thrilled that this solution allows our operating room teams to deliver just that." The 1788 platform is compatible with the currently marketed imaging agents and adaptable to new agents and fluorescence modes as they become available. The advances in this technology also enable a broader range of clinical applications and enhance additional specialties, including urology, neurology, and ear, nose and throat. "Stryker partnered with our surgeon users to design the 1788 platform to be a powerful partner in the OR and to enhance the surgical experience across specialties. This is another way in which Stryker is living up to its rich legacy of delivering the most innovative surgical technology to help surgeons support improved patient outcomes," said Andrés Rosales, vice president and general manager of Stryker's Endoscopy business unit. "The early feedback has been that the 1788 camera delivers better fluorescence imaging and an enhanced user experience, which is particularly helpful in those deep or highly complex cases when surgeons are working in tight cavities—such as sinus cases and pituitary resections," added Rosales. "Clear visualization is a necessity when a patient's life is in your hands. It's important that surgeons can visualize perfusion and critical anatomy to make surgical decisions intraoperatively," said Dr. Albert. Notable features of the 1788 platform include: Wider color gamut for 62.5x more visible colors Improved fluorescence imaging with better consistency High dynamic range and new tone mode for more balanced lighting Cleared to visualize CYTALUX®, an imaging agent designed to illuminate lung and ovarian cancer intraoperatively2 Stryker will debut this new technology at the American College of Surgeons' Clinical Congress on October 23-25, 2023, in Boston at Booth #620. Learn more at stryker.com. About Stryker Stryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com. Media contacts Erin Noel, Inprela 651.677.2027 ext. 1027 enoel@inprela.com Laura Vickers, Stryker 214.926.3673 laura.vickers@stryker.com View original content to download multimedia: SOURCE Stryker Company Codes: NYSE:SYK

100 项与 Pafolacianine 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15413

研发状态

适应症	最高研发状态	国家/地区	公司
肺癌	批准上市	美国更多	On Target Laboratories LLC 更多
造影剂	批准上市	美国更多	On Target Laboratories LLC 更多
卵巢癌	批准上市	美国更多	On Target Laboratories LLC 更多
子宫内膜癌	临床2期	荷兰更多	On Target Laboratories LLC 更多
垂体肿瘤	终止	美国更多	University of Pennsylvania 更多

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临床结果

适应症

分期

评价

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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


NCT04241315 (CTgov)	临床3期	肺癌	112	Near infrared camera imaging system+OTL38 for Injection (Near-Infrared Imaging Group)	繭願襯鑰醖築築遞鏇鹽(廠簾餘艱遞鏇鬱顧廠醖) = 廠構獵鹽繭鬱顧憲繭鏇糧憲廠積鹹簾衊醖鏇醖 (獵廠遞鏇淵網願鑰醖遞, 蓋衊艱鑰衊壓壓鹹選衊 ~ 齋蓋鑰廠醖衊餘膚醖襯) 更多	-	2023-03-23
NCT04241315 (CTgov)	临床3期	肺癌	112	OTL38 for Injection (No Imaging Group)	繭願襯鑰醖築築遞鏇鹽(廠簾餘艱遞鏇鬱顧廠醖) = 範淵築醖艱範顧範艱鏇糧憲廠積鹹簾衊醖鏇醖 (獵廠遞鏇淵網願鑰醖遞, 簾顧壓積積齋壓窪築獵 ~ 鏇鹽糧窪構繭構廠糧鏇) 更多	-	2023-03-23
NCT02317705 (Pubmed \| Obstet Gynecol Surv) 人工标引	临床2期	FOLR1阳性卵巢癌 folate receptor-alpha positive	44	OTL38	(蓋鏇顧鑰糧範範鹹廠顧) = infusion reaction, nausea, vomiting, and abdominal pain 膚鹽淵網積築繭顧網選 (壓壓顧膚製淵範積齋憲 )	积极	2019-10-01
NCT03180307 (Study 006, Pubmed) 人工标引	临床3期	FOLR1阳性卵巢癌 FR Positive	150	Pafolacianine	繭醖醖鹹範壓積獵夢觸(構簾壓鏇鏇壓餘獵艱鏇) = 艱鏇範憲鑰鹹衊鑰糧簾鏇淵繭憲廠憲簾積顧夢 (艱網淵構廠鹽構衊廠鬱, 24.3-42.7) 更多	积极	2022-09-07
NCT03180307 (Study 006, Pubmed) 人工标引	临床3期	FOLR1阳性卵巢癌 FR Positive	150	Pafolacianine (patients who underwent interval debulking surgery)	-	积极	2022-09-07
NCT03180307 (ASCO2021)	临床3期	FOLR1阳性卵巢癌	150	Pafolacianine sodium	(艱窪鏇廠鏇選窪願網鬱) = 4.7% 蓋顧糧廠淵糧築憲齋觸 (鏇衊壓簾築餘襯齋鹽獵 ) 更多	-	2021-05-28
NCT02872701 (CTgov)	临床2期	肺结节 \| 肺癌	100	Endoscopic or Thoracic Surgery+OTL38 for Injection	簾繭鏇夢憲網構淵選獵(鏇願鏇簾製觸糧襯壓襯) = 鏇鏇選網鑰淵顧鹹顧觸窪網繭醖壓醖蓋廠範淵 (艱鹽鬱艱憲願網願製鏇, 窪鏇鑰淵積糧願簾夢製 ~ 構範築齋獵製壓艱選簾) 更多	-	2023-03-24
NCT02317705 (CTgov)	临床2期	FOLR1阳性卵巢癌	48	Laparotomy+OTL38	艱淵願廠鏇鏇鹽窪醖鬱(鏇膚憲遞窪醖製窪鹹淵) = 鏇鬱顧築簾膚構築膚憲鏇憲糧觸醖顧鑰遞衊鬱 (獵醖觸鏇築顧壓範壓醖, 鑰構糧憲襯鹹鑰鏇構餘 ~ 醖鹹醖遞築鏇選顧鹽齋) 更多	-	2022-06-21
NCT02645409 (CTgov)	N/A	肾细胞癌	14	Intraoperative fluorescence imaging system+OTL38 (Partial Nephrectomy)	鹹壓衊鹽壓選構憲鏇淵(構鹹願願艱壓鏇醖餘選) = 積餘繭選簾餘鹽鏇鑰餘廠夢糧願範構鑰觸選窪 (膚選窪憲鏇觸鹹繭觸蓋, 淵糧簾艱窪鹹窪顧餘襯 ~ 選淵鹽簾膚糧鹹網襯製) 更多	-	2020-01-07
NCT02645409 (CTgov)	N/A	肾细胞癌	14	Intraoperative fluorescence imaging system+OTL38 (Radical Nephrectomy)	醖遞襯憲鹽遞選憲鏇築(衊網齋糧範夢鏇簾壓鑰) = 膚廠觸顧製壓鬱築壓蓋構蓋觸齋淵簾淵壓窪選 (糧繭醖範憲艱鏇艱蓋繭, 夢獵醖顧餘鹽鑰壓廠鑰 ~ 齋壓鬱製製選鏇壓願窪) 更多	-	2020-01-07