CENTRAL IMAGING WORKFLOW MANAGEMENT

For studies with imaging derived endpoints (therapeutic or diagnostic efficacy) that require a central review, Medwave will create an image repository with images that passed the study specific QC steps. Central review can be organized in various manners depending on the study needs and the available budget for the central review. As example, Medwave can offer the following imaging review concepts:

1. Central remote radiology review
2. Central radiology remote review with adjudication
3. Risk-based central review
4. Sites connecting to the read software, with the predefined response criteria, to harmonize the assessments among the participating sites.

THERAPEUTIC EFFICACY IMAGING REVIEW:

For oncology studies with efficacy as imaging endpoint, the following tumor response criteria can be covered by Medwave:

• WHO
• Recist 1.0
• Recist 1.1
• mRecist HCC
• irRC
• irRecist 1.1
• Choi
• Cheson
• Lugano classification
• LyRIC
• PCWG2
• RANO
• iRANO

In addition to the established tumor response parameters, Medwave can as well set-up a study specific read methodology to introduce biomarkers as additions response parameter. For example the introduction of parametric maps in modified RANO criteria to differentiate between pseudo-progression and so-called true-progression, and/or to use biomarkers to describe explorative hints of efficacy in early-phase studies.

DIAGNOSTIC EFFICACY OF RADIONUCLIUDES

For determining the diagnostic efficacy of investigational radionuclides, Medwave can perform the following assessments:

• Hot-spot analysis/lesion identification
• Tumor contrast assessments
• Lesion matching
• Standard of truth assessments
• Sensitivity and specificity analysis