Overview
Eligibility
Design Details
Arms & Interventions
Outcome Measures
Trial Sites
Eligibility
Inclusion Criteria
1. Patients must be ≥ 18 years of age.
2. Clinical diagnosis of a metastatic or unresectable grade 1, grade 2 or grade 3 (G1/G2/G3) pancreatic neuroendocrine tumor.
3. Have at least one lesion on clinical imaging (e.g. CT/MRI/PET/CT/ultrasound) that is ≥ 1.5 cm in size.
4. Patients may be receiving any form of treatment or not be undergoing current treatment.
5. Willing to consent to use of tumor tissue (fresh frozen and/or clinical pathology specimens) collected as part of another study or biobank collection or clinical procedure.
6. Must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.
Exclusion Criteria
1. 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.
2. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.
3. 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.
4. 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.
Only individuals (aged 18 or over) who can understand and give informed consent will be approached to participate in this study. Individuals who are considered to be mentally disabled will not be recruited for this study. All subjects must understand and be able to give informed consent. We will not be using specific methods to assess decisional capacity. Economically disadvantaged persons will not be vulnerable to undue influence, as this study offers no compensation. All individuals will be told that their choice regarding study participation will in no way change their access to clinical care. This should negate any undue influence or coercion. Children, fetuses, neonates or prisoners are not included in this research study.
Design Details
AllocationN/A
Intervention ModelSingle Group Assignment
MaskingNone (Open Label)
Number to Enroll12
Arms & Interventions
Interventions
Type: Experimental
Description: Eligible patients will undergo study imaging using a whole-body PET CT scanner25. Dynamic imaging will be obtained beginning immediately prior to the intravenous injection of ≤ 12 mCi of [18F]FTT (a range of 8-12 mCi is anticipated for most dose, a lower dose may be injected if quality images will still be able to be acquired) for a total of approximately 60 minutes. A static scan at approximately 90 minutes post injection will subsequently be obtained. Images will analyzed according to already established image analysis methods, noting extensive experience with [18F]FTT17-21. Kinetic analysis will be performed on the dynamic data akin to prior work in ovarian cancer.
Outcome Measures
Primary Outcome Measures
[18F]FTT SUV in PanNETSBaseline
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.
Secondary Outcome Measures
[18F]FTT SUV and PARP-1 Expression CorrelationBaseline
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.
[18F]FTT SUV and Patient Gene Mutational Status CorrelationBaseline
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.
Trial Sites
This study has 1 trial site
University of Pennsylvania, Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, US