独立中心影像评估

肌肉骨骼

Calyx 是一家领先的医学影像服务提供商,在肌肉骨骼(MSK)影像终点评估方面拥有丰富的经验。在应对 MSK 试验影像方面的诸多挑战时,全球临床试验申办方屡次向 Calyx 求助,希望 Calyx 能提供合适的经验、人员、流程和技术,以推动他们的 MSK 开发项目取得成功。.

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Calyx MSK 专业经验

迄今为止,Calyx Medical Imaging 已为 360 多项 MSK 试验提供了支持,其中许多试验已获得监管部门的批准,Calyx Medical Imaging 在提供可靠的影像数据以证明您正在开发的化合物的安全性和有效性方面具有得天独厚的优势。

值得信赖的专业知识

通过与 Calyx 合作,您可以接触到经验丰富的科学家和医疗专家,他们都是 MSK 成像终点和标准方面的专家,并且了解最新的全球法规。们在 MSK 试验中最常用的成像模式、方案设计以及全球研究机构的图像采集标准化方面提供专业技术知识。

Calyx 的专业技术涵盖 MSK 疾病的所有领域。点击以下链接了解 Calyx 在这些适应症方面的经验:.

轴性脊柱关节炎(AS)的具体特征是骶髂关节(SIJ)出现结构性损伤,在 X 光片上可以明显看到。 这种损伤通常在最初出现症状数年后才会显现。

 

与此相反,与强直性脊柱炎(AS)不同的是,非放射轴性脊柱关节炎(nr-AxSpA)在通过普通X光检查时不会显示出骶髂关节受损的确凿证据。相反,只有通过核磁共振成像才能看到损伤的存在。

 

Calyx 在管理该领域的临床试验方面拥有丰富的专业知识,迄今为止已支持了 20 多项强直性脊柱炎试验。我们的团队与全球知名专家合作,由他们担任这些试验的中心阅片员,确保最高水平的精确性和准确性。

 

单击此处查看 Calyx 科学家在近期 ACR 会议上发表的研究报告。

 

我们支持的轴性脊柱关节炎试验标准/评估包括

  • Modified New York Score (mNY)
  • ASAS OMERACT MRI Score
  • SPARCC for Spine and SIJ
  • Berlin Score
  • FASSS Scoring

X 射线和磁共振成像评估用于支持资格/分层和/或疗效终点。

 

X 射线有时可用于确认是否存在骨侵蚀或并关节骨形成(以支持得出 PsA 的 CASPAR 评分),从而确定是否符合资格。手部和足部关节的 X 光片可用于得出各种标准的评分,如改良范德海德夏普(mTSS)评分,以及支持疗效终点所需的其他变异评分。

 

核磁共振成像用于支持类风湿性关节炎核磁共振成像评分(RAMRIS)、银屑病关节炎核磁共振成像评分(PsAMRIS)以及使用核磁共振成像量化类风湿性关节炎(RAMRIQ)。此外,核磁共振成像(MRI)和超声波成像(US)还用于支持关节炎症,如腱鞘炎等。为了确保定位和图像质量的一致性,使用了专门的手动定位器和模板

 

迄今为止,Calyx 已为 60 多项 RA 和 PsA 临床试验的医学成像需求提供了支持,包括使用以下标准/评估:

  • Sharp Score
  • Van der Heijde Modified Sharp Score
  • Genant Modified Sharp Score
  • RAMRIS and PsAMRIS
  • RAMRIQ (Quantitative RAMRIS)

骨关节炎试验中的成像至关重要,因为其终点与经常评估的关节(膝关节、髋关节、肩关节和手)的关节间隙缩小以及软骨和骨骼参数的变化有关。为了招募到合适的受试者,需要根据试验设计对纳入和排除受试者进行多项评估。这就需要技术和成像方面的专业知识,以及明确的图像采集指南和对现场人员进行培训,以获得一致的 X 射线和核磁共振成像图像。. This requires technical and imaging expertise as well as clear image acquisition guidelines and training of sites to acquire consistent images for X-ray and MRI.

 

Calyx 为超过 35 项骨关节炎试验提供医学影像支持,了解这些试验的特殊需求。 例如,我们向研究机构提供特殊的膝关节、髋关节和手部定位器,并培训技术人员获取适当的视图和角度,特别是因为关节间隙宽度(JSW)对所采用的技术非常敏感。OA 的核磁共振成像还需要在扫描仪上执行专门的协议,并与医疗机构密切合作,及时提供反馈,以优化图像质量。

 

我们为骨关节炎试验支持的一些标准/评估包括

  • KL Grading
  • Joint Space Width
  • OARSI Scores
  • MOAKS / WORMS / BLOKS Scoring
  • Quantitative Cartilage and Bone Shape Assessments (through partnerships with expert third party vendors)

Calyx has successfully supported numerousin the broad area of women’s health in indications such as endometriosis and uterine fibroids assessing efficacy and safety signals using ultrasound and DXA.  DXA has been used to determine eligibility and safety such as bone loss and to support results reporting to sites /sponsors to facilitate treatment decisions during the trials. We have ultrasound and DXA expertise and oversight in authoring standardized guidelines as well as facilitating site training to ensure appropriate imaging and consistency.
Calyx has supported 70 osteoporosis/bone mineral density trials with various drug candidates and biosimilars and has extensive scientific and logistical experience to successfully support such trials.

 

Dual-energy X-ray Absorptiometry (DXA) and X-ray imaging are routinely supported to assess efficacy and safety endpoints as well as support eligibility criteria. Our staff has extensive experience with Osteoporosis research/imaging, and we consult closely with clients to provide feedback on DXA and X-ray-related endpoints and safety signals during protocol development or revisions to ensure these are adequately captured. We also have a network of KOLs we can leverage to advise clients as needed.

 

DXA-derived T-scores as well as vertebral fracture assessments are reported to sites to enable timely decisions. Intelligent eCRF design and automated results reporting as per the unique requirements for each trial are put in place to ensure efficiency. In addition, our team also provides support to address site-central discordance and works closely with sponsors and sites to resolve such issues. Our solutions deployment and scientific staff work closely with the sponsor teams both to ensure the appropriate parameters and readouts are captured in the data exports and appropriate exports are designed to support any regulatory submissions.

 

Some of the criteria/assessments we have supported for Osteoporosis trials are:

  • Bone Mineral Density, T and Z Score Assessment by DXA
  • TBS Scores and Bone Quality
  • QCT Based Finite Element Analysis

Bone age serves as a means of interpreting skeletal maturity, holding significant importance in the comprehensive assessment and guidance of individuals with short or tall stature, impaired or accelerated growth, and delayed or early puberty. This evaluation is particularly relevant in pediatric studies focusing on issues such as obesity or growth hormone deficiencies.

 

An X-ray of the hand and wrist are acquired and assessed by comparing it to the Greulich and Pyle Atlas. At Calyx, we have extensive expertise in this field and a knowledgeable team of readers. Additionally, we have the advantage of utilizing automated bone age assessment software (BoneXpert) based on the requirements of the trial.

 

Some of the criteria/assessments we have supported for Bone Age trials are:

  • Greulich and Pyle Bone Age Assessment (reader and / or automated software based)
  • Tanner Whitehouse and Fels using Bone Age Software (automated software based)

Calyx experience with Gout imaging has included photography, X-ray, MRI, US and Dual Energy CT (DECT).  DECT is used to detect the presence and quantify the extent of monosodium urate (MSU) crystals, which is a characteristic feature of tophaceous gout.

 

Our team is well-versed in the field of Gout, and we have the privilege of collaborating with Gout Key Opinion Leaders (KOLs) including Massachusetts General Hospital (MGH), who are renowned for their expertise in DECT analysis for Gout. Both our in-house experts and the KOLs are available for additional guidance to our clients as necessary.

Calyx has extensive experience with disorders related to muscle and fat changes such as Diabetes, Sarcopenia, Duchene Muscular Dystrophy, metabolic dysfunction, and Obesity-related changes in body composition measures related but not restricted to muscle and fat changes either in the whole body or at specific anatomic locations. Typically, most of these assessments are quantitative (volume or mass) with some being semi-quantitative.

 

We have worked with various modalities including DXA, CT, and MRI to delineate changes in these various anatomical locations. We can work on intra-muscular fat assessments using MRI sequences as appropriate and partner with third-party vendors on a need basis to facilitate the successful implementation of the right protocols and derive endpoints. We have dedicated expertise in-house to tailor sequences to achieve the desired outcomes in a standardized fashion which included direct communication with sites during initial protocol setup and robust QC to provide feedback.

Calyx has experience in supporting various pediatric and adult rare indications affecting the musculoskeletal system such as Gaucher’s disease, Osteogenesis Imperfecta, Pompe disease, Duchenne Muscular Dystrophy, Spinal Muscular Atrophy (SMA), Achondroplasia and Fibrodysplasia Ossificans Progressive (FOP). We work closely with the client and expert readers/ KOLs to define the endpoints and design appropriate eCRFs to capture efficacy and safety endpoints to support decisions employing various modalities including but not restricted to X-ray, US, MRI, DXA, CT etc.

We tailor the image acquisition guidelines to ensure adequate coverage and appropriate views and implementation of scanning protocols. Toward this end, our experienced technical staff work closely with the sites to review protocol implementation, phantom scan acquisitions as appropriate, and tailored training.  Given the nature of rare diseases and the unique image assessments involved, Calyx is well positioned to provide guidance as well as work closely with relevant experts from the field as needed.

Some of the criteria/assessments we have supported for Rare Disease trials are:

  • Quantification of Heterotrophic Bone Ossification
  • MRI-based bone marrow burden Score (BMB score)
  • X-ray and MRI-based Assessments in Pediatric and Adult Populations for Rare Diseases
  • DXA based BMD Assessments
  • Variety of Qualitative Assessments based on Trial Endpoints
  • Muscle Quality and Volume

认识我们的 MSK 专家

与 Calyx 合作,您可以接触到业内最有经验的 MSK 成像专家。我们的内部医学影像专家包括医学博士、博士、影像技师、影像物理学家和专门的探索性影像小组,他们都具备良好的条件,可以帮助您从新颖的影像方法中获得所需的信息。

与我们肌肉骨骼领域的专家交流

Calyx 的 KOL 网络

我们与您合作,为您的试验确定最可靠的读片人员和最佳读片模式,平衡他们的读片量,确保读片人员之间的低变异性,从而为您的研究提供最高质量的成像读片

。我们在选择 MSK 经验丰富的读片员方面具有灵活性,您几乎可以利用任何 KOL 作为专家读片员,包括

Prof. Jürgen Braun (Germany)
Dr. Kay-Geert Hermann (Germany)
Prof. Robert Landewe (Netherlands)
Prof. Désirée van der Heijde (Netherlands)
Dr. Charles Peterfy (USA)
Dr. William Palmer (USA)
Expert team at Massachusetts General Hospital

MSK 临床试验模式

Calyx Medical Imaging 在绝大多数用于支持 MSK 相关治疗开发的成像模式方面提供专业技术,包括

在许多适应症中,X 射线成像是一种非常常见的方式,用于支持 Ra/PsA、OA、OP 等的资格、疗效和安全性。

 

Calyx 精通此类评估所需的要求和技术/观点。Calyx 制定了简洁明了、便于现场/技术人员使用的指南,以实现一致、稳健的成像,其中概述了视图和技术参数,如 KvP、准直以及使用模板进行一致定位等。

磁共振成像是一种用途广泛的技术,可用于涉及骨骼、肌肉和关节的各种适应症,以评估疾病早期和晚期的结构和炎症变化,或监测疾病的进展或缓解。Calyx 已成功支持了多项针对不同适应症(如 Ra、PsA、OA、AxSpA)的磁共振成像读出研究,以支持资格以及安全性/有效性读出。

 

Calyx 与研究机构密切合作,在研究机构的 MRI 扫描仪上实施最合适的方案,并在图像采集指南 (IAG) 中明确提出要求。我们的内部 MRI 专家会根据模型成像或首例受试者的扫描质量向研究机构提供培训和反馈,以确保适当的扫描和质量。

CT 作为一种模式可用于多种适应症,需要对解剖结构中不同层次的骨骼、脂肪和肌肉组织进行定量或定性评估。Calyx 已在强直性脊柱炎和前列腺增生症等适应症中进行了大量试验,研究骨质变化以及骨质增生和异位骨形成的量化。我们还支持单层和多层 CT 扫描,以确定肌肉和脂肪含量,并在临床研究中分离皮下脂肪和内脏脂肪,研究肥胖、DMD、肌肉疏松症、恶性贫血等代谢变化和疾病。我们训练有素的员工会进行全面的质量控制,确保进行适当的分割,以便放射科医生进行快速有效的集中审查。

 

Calyx 还与第三方供应商和 KOL 合作者密切合作,对各种骨骼异常进行 CT 定量分析,包括评估体积 BMD 和骨强度以及皮质和小梁微结构。 我们与 ON Diagnostics 合作提供有限元分析,特别是与骨同化治疗候选药物相关的分析。我们还与 KOL 和学术实验室合作,帮助获得专业和特殊的评估,如骨小梁和皮质结构,如骨小梁厚度和骨量以及皮质薄度和孔隙率,这些评估可提供短期或长期药物安全效应的关键信息。

双能 X 射线吸收测定法(DXA)是临床试验的首选成像方法,它以骨矿密度的变化和/或瘦体重和脂肪的身体成分变化作为结果测量指标,例如骨质疏松症和肥胖症。根据不同的适应症,DXA 对于确定治疗对骨质的疗效或安全性至关重要。例如,髋关节和脊柱 BMD 的变化是骨质疏松症候选药物的关键疗效终点,而骨质流失则是许多适应症的安全终点,如妇女的子宫内膜异位症和子宫肌瘤,或慢性疾病、成人和青少年关节炎等炎症。

 

在肥胖症、糖尿病、艾滋病等适应症中,也可通过 DXA 监测身体成分的变化,如骨量、瘦肉或脂肪量的变化。

 

Calyx 在支持全球和特定地区 DXA 试验的各个阶段都拥有丰富的经验,我们与客户和合作伙伴/研究机构密切合作,确保遵守适当的成像准则,并及时完成仪器质量控制等关键步骤。

 

Calyx 还与第三方供应商合作,为研究骨质指数的试验提供 TBS 评分。Calyx 经验丰富的运营和科研团队从试验一开始就与客户密切合作,以确定合适的扫描仪,确定对现场技术人员的充分培训,并及时提供图像质量反馈。

超声波在各种适应症中的应用不断扩大,并经常作为一种方式用于许多 MSK 适应症。 使用超声的一些适应症包括血友病和骨关节炎。由于超声换能器分辨率的提高,小关节的超声诊断在临床和研究中变得越来越普遍。 超声波不使用辐射,无痛苦,是观察关节解剖结构和功能的有效方法。 超声设备方便、便携,可提供实时可视化和评估。

 

鉴于 MSK 超声波成像的复杂性和所要求的精确性,Calyx 强烈建议只有具有丰富 MSK 扫描经验的超声波技师和医生才能获取图像。摄影

摄影是评估和追踪痛风的炎症、发红和软骨炎的重要工具。 手部和足部的照片最为常见,肘部、膝部和其他受影响关节的照片也很常见。 可以使用类似 RECIST 1.1 的标准,利用风湿病学计算机辅助摄影评估 (CAPER) 方法,通过摄影来评估痛风病灶负担的减轻情况。

全球支持

Calyx 的运营模式使我们的客户交付团队能够预测您的研究需求,并扩展我们的服务,通过高效的站点设置、专门的 QC 支持团队和减少的成像查询,提供快速可靠的连续性服务,以满足您的试验时间表。

Calyx Medical Imaging 通过具有 MSK 试验经验的项目经理提供深入的运营监督,为试验申办方提供 MSK 治疗开发各阶段所需的灵活性和可扩展性,帮助他们克服挑战,自信地应对意外的试验变更。

凭借在印度、中国、北美和欧洲的本地支持,您可以确信 MSK 试验的成像部分将顺利进行,并提供值得信赖的高质量数据。凯理斯将始终致力于提供让您满意的服务。凯理斯将始终致力于提供让您满意的服务。

了解我们在治疗领域的专业知识

凯理斯的专业知识涵盖临床开发的各个阶段和不同的治疗领域。除中枢神经系统外,在肿瘤、肌肉骨骼和众多许多治疗领域新疗法的临床开发方面,我们能够提供医学影像服务,并拥有丰富经验和备受认可的业务能力。

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