ERT provided CT/MRI and PET imaging for a mid-sized pharmaceutical company in Phase IB and II studies measuring tumor assessment efficacy endpoints for chronic lymphocytic leukemia, mantle cell lymphoma and small lymphocytic lymphoma (B-cell lymphoid malignancies).
The Sponsor’s Data Accuracy, Standardization and Harmonization Concerns
The sponsor required computed tomography (CT) and positron emission tomography (PET) imaging for its image acquisition protocol (IAP) and image evaluation protocol (IEP) to support tumor assessment efficacy endpoints. However, PET imaging in oncology studies is notorious for yielding false positive and false negative events, and there were concerns about standardizing the IAP and harmonizing image quality across all sites globally.
The sponsor leveraged ERT’s experience standardizing IAPs and harmonizing image quality, in addition to ERT’s proprietary, peer-reviewed, validated PET image processing and analysis software.
ERT’s Purpose-Built Imaging Solution
The sponsor could confidently execute study imaging protocols and workflows knowing:
- Inter-site image quality would be optimized
- PET evaluation data would be objective, quantitative and reproducible
- PET imaging data could be accurately compared across subjects, study sites and scanners