FTT PET/CT in Pancreatic Neuroendocrine Tumors

NCT07114939 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: UPCC 15224857067
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Neuroendocrine Carcinoma Metastatic; Pancreatic Tumors

Keywords

Grade 1, 2 or 3 pancreatic neuroendocrine tumors

Outcome Measures

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.

  Baseline

Secondary Outcomes (2)

• [18F]FTT SUV and PARP-1 Expression Correlation

  Baseline

• [18F]FTT SUV and Patient Gene Mutational Status Correlation

  Baseline

Study Arms (1)

18F-FTT PET/CT

EXPERIMENTAL

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 may subsequently be obtained up to 90 minutes post radiotracer injection, per the PIs discretion. 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.

Drug: [18F]FluorThanatrace

Interventions

[18F]FluorThanatrace DRUG

Intravenous injection of ≤ 12 mCi of \[18F\]FTT for whole-body PET CT dynamic imaging and subsequent static scan.

Also known as: [18F]FTT

18F-FTT PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• University of Pennsylvania: collaborator

Study Sites (1)

University of Pennsylvania, Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Austin Pantel, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin K Schubert, MS

CONTACT

215-573-6569; erinschu@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 11, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

US (1)