PARP-1 Targeting With the Novel Radiotracer [18F]FTT in Pancreatic Neuroendocrine Tumors

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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 at 90 minutes post injection will subsequently be obtained. \[18F\]FTT uptake will be measured on the PET scan and correlated with two molecular outcomes.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• 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.

• 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.

Locations
United States
Pennsylvania
University of Pennsylvania, Perelman Center for Advanced Medicine
RECRUITING
Philadelphia
Contact Information
Primary
Erin K Schubert, MS
erinschu@pennmedicine.upenn.edu
215-573-6569
Time Frame
Start Date: 2025-10-01
Estimated Completion Date: 2027-09
Participants
Target number of participants: 12
Treatments
Experimental: 18F-FTT PET/CT
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.
Sponsors
Leads: Abramson Cancer Center at Penn Medicine
Collaborators: University of Pennsylvania

This content was sourced from clinicaltrials.gov

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