NCT03492164

In Vivo PARP-1 Expression With 18F-FTT PET/CT in Pancreatic Cancer

Evaluating in Vivo PARP-1 Expression With 18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Pancreatic Cancer

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	[18F]FluorThanatrace ([18F]FTT)	1-(4-(2-Fluoroethoxy)phenyl)-8,9-dihiydro-2,7,9a-triazabenzo\[cd\]azulen-6(7H)-one also known as \[18F\]FluorThanatrace or \[18F\]FTT is a positron emitting radiopharmaceutical that has been studied in animals for selective measurement of the in vivo inhibition of the PARP-1 nuclear enzyme with positron emission tomography (PET/CT).

Timeline

• Start date: 2018-03-20
• Primary completion: 2024-06-11
• Completion: 2024-06-11
• First posted: 2018-04-10
• Last updated: 2024-06-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study