RECRUITINGPhase 1INTERVENTIONAL
FTT PET/CT in Pancreatic Neuroendocrine Tumors
PARP-1 Targeting With the Novel Radiotracer [18F]FTT in Pancreatic Neuroendocrine Tumors
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.
Who May Be Eligible (Plain English)
Who May Qualify:
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 willing to sign a consent form and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.
Who Should NOT Join This Trial:
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.
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
[18F]FluorThanatrace
Intravenous injection of ≤ 12 mCi of \[18F\]FTT for whole-body PET CT dynamic imaging and subsequent static scan.
Locations (1)
University of Pennsylvania, Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States