In Vivo PARP-1 Expression With 18F-FTT PET/CT in Pancreatic Cancer
Status:
Recruiting
Trial end date:
2024-03-20
Target enrollment:
Participant gender:
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.
Phase:
Early Phase 1
Details
Lead Sponsor:
Abramson Cancer Center of the University of Pennsylvania