FTT PET/CT in Pancreatic Neuroendocrine Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbramson Cancer Center at Penn Medicine
About this trial
A pilot study to evaluate the expression of PARP-1 in patients with pancreatic neuroendocrine tumors will be conducted. This will be done via the use of a novel PET imaging agent, \[18F\]FluorThanatrace (\[18F\]FTT). A total of 12 patients will be enrolled. Patients will undergo a study imaging assessment using a whole-body PET CT scanner. Dynamic images will be obtained beginning immediately prior to the administration of 10 mCi of \[18F\]FTT (±20%) for a total of 60 minutes. A static scan may subsequently be obtained up to 90 minutes post radiotracer injection, per the PI's discretion. \[18F\]FTT uptake will be measured on the PET scan and correlated with two molecular outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients must be ≥ 18 years of age.
Clinical diagnosis of a metastatic or unresectable grade 1, grade 2 or grade 3 (G1/G2/G3) pancreatic neuroendocrine tumor.
Have at least one lesion on clinical imaging (e.g. CT/MRI/PET/CT/ultrasound) that is ≥ 1.5 cm in size.
Patients may be receiving any form of treatment or not be undergoing current treatment.
Disqualifiers
Patients who have received liver directed therapy that treated all of their disease but whom have not yet had disease progression, per medical record review.
Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.
Females who are pregnant or breastfeeding will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential prior to FTT injection.
Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participating in the study.
Trial design
Design model
Single group
Treatments tested in this trial
[18F]FluorThanatrace
DrugIntravenous injection of ≤ 12 mCi of \[18F\]FTT for whole-body PET CT dynamic imaging and subsequent static scan.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: 18F-FTT PET/CTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
[18F]FTT SUV in PanNETS
Evaluate the standard uptake value (SUV) of \[18F\]FTT in pancreatic neuroendocrine tumors (PanNETS). SUV is a measure of concentration of radioactivity/tracer in a specific tissue or organ usually calculated by weight or BMI.
Time frame
BaselineSecondary outcomes
1
[18F]FTT SUV and PARP-1 Expression Correlation
Correlate \[18F\]FTT standard uptake value (SUV) with PARP-1 expression (immunofluorescence) in patient tumor specimens. SUV is a measure of concentration of radioactivity/tracer in a specific tissue or organ. The intensity of the immunofluorescence is quantified using image analysis software.
Time frame
Baseline2
[18F]FTT SUV and Patient Gene Mutational Status Correlation
Correlate \[18F\]FTT standard uptake value (SUV) with MEN1/DAXX/ATRX patient gene mutational status through next generational sequencing (NGS). SUV is a measure of concentration of radioactivity/tracer in a specific tissue or organ. NGS is a method that allows for comprehensive analysis of multiple genes simultaneously.
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Abramson Cancer Center at Penn Medicine
Lead sponsor
University of Pennsylvania
Collaborator
Source ClinicalTrials.gov