Tumor Imaging and Assessment of Disease Sample Clauses

Tumor Imaging and Assessment of Disease. The patient’s pancreatic cancer will be evaluated by the investigator based on tumor assessments using RECIST 1.1 and iRECIST criteria (Appendix 5). Tumor assessments for evaluation of response will be conducted using CT or MRI, approximately every 9 ± 1 weeks until trial discontinuation or disease progression, whichever is later. All sites of disease must be followed using the same baseline assessment method. CT is the preferred imaging modality for this study. I.V. contrast should be administered, unless medically contraindicated. If CT with I.V. contrast is contraindicated, the alternative is to acquire a CT of the chest without contrast and MRI of the abdomen and pelvis with gadolinium contrast. Other protocols, such as non-contrast CT of chest abdomen pelvis, should not be performed. For CT scans oral contrast should be administered in addition to IV contrast. Radiolucent agents (e.g., water) are generally preferred over radiopaque agents (e.g., iodine and barium- based agents). All target lesions will be measured by consistent imaging techniques for each patient throughout the trial. Suitable imaging techniques include CT-scan, or MRI. The same technique should be used for each evaluation in an individual patient. Copies of the scans must be available for review. In addition, a central radiologist, blinded to the treatment assignment, will perform an independent read of each scan, assessing tumor response using RECIST 1.1 and iRECIST criteria (Appendix 5). In the event that PD by RECIST 1.1 or iUPD is determined, a repeat scan must be performed within 4 - 6 weeks to confirm PD. Trial treatment may be continued during this time (past the initial PD assessment) but only if patient is clinically stable as defined by: • No worsening of performance status • No clinically relevant increase in disease related symptoms • No requirement for intensified management of disease related symptoms (analgesics, radiation, palliative care) If the investigator assesses a patient to have PD (defined by RECIST 1.1), the central radiologist will review the scan to confirm the PD, prior to the discontinuation of trial treatment. CA19-9 assessments (or CEA or CA-125 for not expressers of CA19-9) will be taken at baseline and approximately every 21 days during the trial treatment period. All CA19-9 assessments must be assayed by the same laboratory for each patient. Disease progression will not be determined by CA19-9, however increases in CA19-9 may warrant the investigator...