Imaging Requirements (Only Sample Clauses

Imaging Requirements (Only. Applies to Subjects with Known Non-CNS Extramedullary Disease at Baseline)  Extramedullary disease will be assessed prior to baseline with an imaging modality appropriate for the anatomical site and clinical scenario (eg, MRI for CNS lesion, ultrasound for testicular lesion, CT for intra-abdominal or thoracic lesion).  For all subjects with known non-CNS extramedullary disease, images must be taken within 28 days before conditioning chemotherapy. In addition, for subjects receiving bridging chemotherapy, images must be taken after bridging chemotherapy has completed.  Following KTE-X19 infusion, the first on study images will occur at the time of first presumed response (ie, bone marrow blasts ≤ 5%)  Subsequent images will continue as per the SOA through Month 24 or disease progression, whichever occurs first. If the subject’s disease has not progressed by Month 24, then images will be performed per standard of care until disease progression.  All on-study assessments of extramedullary disease detected through imaging should be made with the same imaging modality and of the same anatomical locations as imaged at baseline.  Response is evaluated by the investigator (Appendix 1).  For all subjects, images should be performed per standard of care anytime the subject presents with symptoms suggestive of disease progression CCI  Images will be submitted to a central imaging vendor; central imaging vendor manual to be provided separately.