Recruiting
Phase 1

\[18F\]FluorThanatrace

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT07114939

Conditions

Neuroendocrine Carcinoma Metastatic

Pancreatic Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

[18F]FluorThanatrace

Study Details

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

Study ID

NCT07114939

Start date

Oct 1, 2025

Status verified date

Jan, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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 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.

Interventions

[18F]FluorThanatrace

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

Primary outcome measure

  • [18F]FTT SUV in PanNETS [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Erin K Schubert, MS

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

Locations

University of Pennsylvania, Perelman Center for Advanced Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Erin K Schubert, MS

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

Principal Investigator:

Austin Pantel, MD

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Feb 2, 2026

Last verified

Jan, 2026

Keywords

  • Grade 1, 2 or 3 pancreatic neuroendocrine tumors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2026-02-02.