Advanced Musculoskeletal Medical Imaging
With more than 30 years of experience, Bioclinica offers clinical trial sponsors unmatched expertise, scientific insight and proven centralized imaging services necessary to make timely, critical go/no-go decisions and generate pivotal efficacy or safety information required for a successful regulatory submission.
Bioclinica’s MSK expertise includes support for the latest developments in imaging endpoints and a deep background in Rheumatoid and Psoriatic Arthritis, Spondyloarthritis, Osteoarthritis, Osteoporosis and more. Our imaging scientists and technologists and dedicated MSK project teams have delivered quality service and independent image review in support of hundreds of early and late phase clinical trials.
650+ MSK Studies
17,000 Sites Supported
Leverage Customized Project Excellence
A thorough understanding of imaging endpoints allows us to assign the appropriate resources and scientific experts to match the needs of your study, from protocol design to regulatory submission. Furthermore, Bioclinica’s leading central independent image acquisition and analysis process improves image quality and standardization, providing for highly-reproducible results and inspection-ready data.
- Comprehensive site imaging technologist training
- MSK dedicated project teams
- Multi-center standardization and calibration of imaging equipment
- Full 21 CFR Part 11 and ICH/GCP compliance
- Global operations for local, 24/7 support
- Customized, real-time online reporting
- Network of Key Opinion Leaders
Bioclinica is well-versed with the most common imaging modality used in trials for clinical indications such as rheumatoid arthritis, osteoarthritis, osteoporosis and other indications. Our team understands that the proper acquisition technique for the most precise assessments or measurements and has developed techniques to effectively and rapidly train imaging technologists around the globe. Whether performing semiquantitative assessment of erosions and joint space narrowing in RA or vertebral fracture in osteoporosis or making reproducible measurements of knee or hip joint space width in OA, Bioclinica’s experienced team and industry leading processes ensure subtle changes are precisely measured.
Magnetic Resonance Imaging (MRI)
MRI is a versatile imaging tool for assessing bones, joints and muscles. Bioclinica has successfully completed numerous studies utilizing MRI and the MRI scoring systems recommended by OMERACT for both RA and PsA, partnering with the academic leaders responsible for the development of these systems to provide expert assessment of inflammation and joint destruction. Similarly, MR images of the sacroiliac joint and spine in patients with Spondyloarthrits (SpA) and Ankylosing Spondylitis (AS) can be evaluated for bone marrow edema and structural change with methods developed by Spondyloarthritis Research Consortium of Canada (SPARCC) and others.
Bioclinica collaborates with world experts for the semiquantitative and quantitative assessment of MRI in knee Osteoarthritis (OA). Whole Organ scoring methods like (WORMS) and MOAKS are proven techniques to assess disease severity and evaluate inflammatory and structural changes over time when performed by highly experienced MSK radiologists. Bioclinica also supports the use of MRI for novel quantitative endpoints in knee OA using in-house analysis tools and through partnerships with specialty image analysis labs like Chondrometrics and Imorphics. Available endpoints include cartilage morphology and composition, articular bone shape, synovitis and bone marrow edema. Successful use of these endpoints in multi-center clinical trials requires tightly controlled image acquisition to detect small changes associated with disease progression.
MR imaging of muscle employs sophisticated imaging techniques to quantify muscle volume (T1-weighted imaging), fat infiltration of muscle (multi-point Dixon imaging) and inflammation (T2 mapping). These techniques provide a comprehensive assessment of muscle features related to functional capacity and allow high sensitivity to detect change associated with therapeutic interventions, exercise regimens and wasting conditions.
Dual Energy X-Ray Absorptiometry (DXA)
DXA is the most widely available method for the non-invasive, quantitative assessment of bone mineral density (BMD). Ease of access, low radiation dose and patient compliance make DXA a favored tool for evaluation of both therapeutic response in osteoporosis but also harmful effects of drugs that interfere with the normal bone metabolism or maturation. To ensure the quality of DXA BMD measurements Bioclinica’s experts offer services not only to standardize scan acquisition and analysis but also monitor scanner calibration over time and among investigator sites. Our long relationship with the scientists GE Lunar and Hologic have instilled deep knowledge of DXA in our team and ensure your trials run smoothly.
When BMD is not enough for your study needs, Bioclinica also supports advanced analysis of DXA scans for assessing bone geometry by Hip Structural Analysis and bone texture using the Trabecular Bone Score (TBS). These analysis methods can be applied to most modern DXA scans and offer additional information about bone strength beyond BMD, which can help demonstrate the benefits of experimental treatments.
DXA is not limited to skeletal assessment and is widely used to measure body composition. The whole body DXA scan (available on many DXA scanners) also provides measurements of lean and fat mass in the total body as well as body subregions (e.g., arms, legs and trunk). Estimates of visceral adipose tissue mass are also available from whole body DXA scans. Bioclinica’s scientists can advise on the use of DXA for measuring fat in studies of obesity, diabetes, lipodystrophy and others as well as lean (muscle) mass in sarcopenia or wasting disease.
Quantitative Computed Tomography (QCT)
Understanding the effect of a drug on bone strength often requires methods more sophisticated than DXA. QCT uses clinical CT scanners, calibration tools and advanced software to measure volumetric BMD, bone geometry and even to make estimates of bone strength. Bioclinica scientists have been pioneers in QCT research for decades and have supervised the majority of clinical trials using QCT to evaluate bone strength. Using carefully designed, low-dose acquisition protocols Bioclinica has trained scores of imaging facilities around the world to collect high quality images for measuring QCT BMD of the spine, femur, forearm and knee. Proprietary calibration phantoms and custom-built software provide the means for detailed assessment of cortical, trabecular and integral BMD as well as bone geometry and strength indices. Partnering with O.N. Diagnostics, Bioclinica provides estimates of bone strength using finite element analysis techniques validated by mechanical testing of bone specimens. These methods provide insights into the benefits of bone building therapies. For example, in early phase trials, QCT allows detailed comparison of response in different treatment arms or even to approved therapies, allowing you to make critical program decisions with confidence. QCT techniques can also provide more power to detect or discount potential deleterious effects of new drugs to address regulatory questions about bone toxicity.
When bone quality or microarchitecture is critical to your research questions, Bioclinica has the expertise and track record to employ high-resolution peripheral QCT for submillimeter resolution of cancellous bone. With HR-pQCT, bone microarchitecture like trabecular thickness and spacing, trabecular number and cortical porosity can be interrogated in vivo, answering research questions about method of action not previously available in a multi-center setting.
Our portfolio of visual and quantitative assessment criteria includes:
- Genant Semiquantitative Vertebral Fracture Grading
- Vertebral Quantitative Morphometry
- DXA BMD
- DXA Hip Structural Analysis
- DXA Trabecular Bone Score
- DXA Body Composition
- QCT BMD
- QCT Bone Geometry
- QCT Finite Element Analysis
- Bone Age
- Multi-Point Dixon Imaging
- Diffusion Weight Imaging
- Sharp Scoring
- van der Heijde-Modified Sharp Scoring
- Genant-Modified Sharp Scoring
- OMERACT RAMRIS & PsAMRIS
- Quantitative RAMRIS (RAMRIQ)
- Kellgren-Lawrence Grading
- OARSI Scoring
- Joint Space Width (JSW)
- WORMS/BLOKS/MOAKS Scoring
- Dynamic Contrast Enhanced MRI
- T2/T2* Mapping
Bioclinica’s MSK Therapeutic Strengths
MSK Disease and Orthopedics
- Fracture Healing & Repair
- Cartilage Repair
- Joint Arthroplasty
- Spine Arthroplasty
- Spine Arthrodesis
- Rheumatoid Arthritis
- Psoriatic Arthritis
- Spondyloarthritis & Ankylosing Spondylitis
- Sjogren’s Disease
- Juvenile Idiopathic Arthritis
- Growth Hormone Deficiency
- Osteogenesis Imperfecta
- Fibrodysplasia Ossificans Progressiva
- Duchenne Muscular Dystrophy
Bone Safety Assessment
- Uterine Fibroids
RESOUCES FROM TRUSTED
Impact of meniscal coverage on subchondral bone mineral density of the proximal tibia in female subjects – A cross-sectional in vivo study using QCT
Abstract: Objective: To verify earlier data in cadavers that in female subjects with OA meniscal coverage is associated with lowered…