Whether your prospective compound or novel radiotracer is in the early or late stage of trial development, CoreLab Partners’ Molecular Imaging services can be leveraged to successfully gather, analyze, and deliver crucial functional imaging data. For early phase trials, we work with you to provide high quality imaging efficacy data that empowers you to expedite critical go/no-go decisions. Your project team will be able to identify ineffective compounds earlier, saving valuable time and resources, while allowing only your most promising compounds to advance in your drug-development pipeline.
For late-phase trials, we provide functional imaging data that can be used as an exploratory endpoint or integrated with anatomic imaging data. This data can be utilized for internal decision-making and/or prepared for agency submission.
At CoreLab Partners, we understand that functional imaging, data acquisition, and analysis require attention to detail to ensure robust, accurate data sets. To that end, our certified imaging technologists and medical physicists work with qualified imaging facilities prior to and throughout the duration of the study.
Using advanced, validated image analysis technology, CoreLab Partners’ board-certified radiologists and nuclear medicine physicians evaluate imaging data both qualitatively and quantitatively. Sophisticated image analysis tools are applied to traditional imaging modalities, including computed tomography (CT) and magnetic resonance imaging (MRI); to functional imaging modalities such as positron emission tomography (PET), nuclear medicine gamma camera imaging and single-photon emission computed tomography (SPECT); and to combined data acquired from hybrid imaging systems, such as PET/CT and SPECT/CT.
- 36+ years accelerating drug and medical device development
- On-staff, board-certified physicians, scientists, and technologists with decades of combined expertise
- Proven operational processes
- Broad therapeutic range including oncology, cardiovascular, musculoskeletal, CNS (including Alzheimers’ disease), diagnostic imaging agents, and medical devices
- Strong expertise developing customized drug and target specific protocols
CoreLab Partners’ experience in the management of medical imaging for oncology clinical trials is unrivaled and includes medical expertise in all major oncologic tumor types. Our comprehensive molecular imaging service has a proven track record for accelerated drug-development process in both domestic and global oncology trials.
Molecular Imaging Service: FDG-PET
In addition to CoreLab Partners’ world-class image management process, our molecular imaging service provides value-added project management and expert service tailored to your study needs and specifications, including the following:
Imaging Facility Qualification
Image Quality Assessment
- Imaging facility evaluation
- Data format testing
- Qualitative and quantitative phantom assessments
- Imaging system stability and consistency analysis
- Physicist and technologist support
- Pass/fail threshold criteria specific to your study
- Escalation, communication, and correction plans
CoreLab Partners continues to evolve and expand its molecular imaging capabilities into new therapeutic areas including the assessment of novel diagnostic SPECT and PET diagnostic agents for analyzing cardiac and neurological diseases using state-of-the-art image assessment tools.
- Flexible assessment paradigms
- Stand-alone FDG-PET analysis
- CT defined with correlative FDG-PET analysis
- Lesion evaluation assessment
- Qualitative assessment including Juweid and Deauville for Lymphoma
Quantitative assessment including SUVmean, SUVmax, SUVpeak, and glycolytic index
- Anatomolecular correlation—expertise in integrating physiologic and anatomic interpretation
- Response assessment criteria
- IHP 2007—Lymphoma
- EORTC—Solid tumor
- RECIST 1.1
- Abbreviated timelines
- Cost and time efficiencies for expedited go/no-go decision making
- Fast-tracked regulatory review based upon credible trial data and processes
- Quality customer service including on-staff physicians, nuclear medicine physicists, technologists, and project teams ready to support your critical product development needs
- Comprehensive service including complete end-to-end medical imaging solutions
CoreLab Partners' Commitment
- Quality, service, and results
- Sponsor satisfaction
- Innovative solutions
- Ongoing process improvement