in vivo parp-1 expression with 18f-ftt pet/ct in pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the investigators plan to enroll 30 evaluable patients with (1) a histological diagnosis of advanced pancreatic ductal adenocarcinoma who have demonstrated at least stable disease following ≥16 weeks of treatment with platinum-based chemotherapy and (2) who have signed consent to participate in a clinical trial that contains parp inhibitor therapy and are anticipated to receive this treatment or (3) will receive parp inhibitor therapy as part of their clinical care. a pre-treatment 18f-fluorthanatrace (\[18f\]ftt) positron emission tomography/computed tomography (pet/ct) scan will be done prior to the start of treatment with a parp inhibitor. pet/ct imaging will be used to evaluate parp-1 expression in sites of pancreatic cancer using the investigational radiotracer \[18f\]ftt. this is an observational study in that \[18f\]ftt pet/ct will not be used to direct treatment decisions. while patients and referring physicians will not be blinded to the \[18f\]ftt pet/ct results, treatment decisions will be made by the treating physicians based upon clinical criteria. patients will undergo approximately 60 minutes of dynamic scanning starting at the time of injection of \[18f\]ftt. this procedure will be followed by a skull base to mid-thigh scan, starting at approximately 60 minutes post injection. pet/ct imaging sessions will include an injection of approximately 10 mci (approximate range for most studies is anticipated to be 8-12 mci) of \[18f\]ftt. data will be collected to evaluate uptake of \[18f\]ftt in sites of pancreatic cancer, which will be compared with parp-1 expression in tissue, when available. all 30 evaluable patients are expected to start parp inhibitor therapy following the \[18f\]ftt pet/ct scan. it is expected that due to patient preference and time considerations, approximately 24 patients (80%) will also undergo a second (optional) scan that will be performed approximately 3 weeks (± 1 week) after therapy has started. the second scan is obtained to evaluate whether the parp inhibitor therapy decreases \[18f\]ftt uptake, which would suggest parp blocking by the therapy.


Eligibility criteria:
inclusion criteria: * participants will be ≥ 18 years of age. * histologically proven pancreatic adenocarcinoma. . * deemed to have achieved stability following ≥16 weeks of platinum based therapy, in the opinion of an investigator * considered a candidate for parp inhibitor therapy, with or without additional agents, either on a clinical trial or as part of clinical care. * participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures. exclusion criteria: * females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential at screening. * inability to tolerate imaging procedures in the opinion of an investigator or treating physician * serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.