BACKGROUND Company: Mid-sized pharmaceutical company Indication(s): Chronic lymphocytic leukemia, mantle cell lymphoma and small lymphocytic lymphoma (B-cell lymphoid malignancies) Phases: IB and II CHALLENGE 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 relative to the quantification of the PET signal (e.g., glucose uptake), confirmation of disease progression, evaluation of response to treatment and definition of malignancy. The sponsor was also concerned about standardizing the IAP and harmonizing image

Join for free to read