FTT PET/CT imaging to detect PARP‑1 in pancreatic neuroendocrine tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will enroll 12 adults with metastatic or unresectable grade 1–3 pancreatic neuroendocrine tumors and perform whole‑body PET/CT imaging after injection of approximately 10 mCi (±20%) of [18F]FTT. Dynamic PET images will be acquired starting immediately before injection and continuing for 60 minutes, and a static scan may be obtained up to 90 minutes post‑injection at the investigator's discretion. Tumor uptake of [18F]FTT will be quantified and correlated with PARP‑1 expression in tissue specimens and with underlying mutational status. The protocol allows patients to be on or off current therapies and requires at least one lesion ≥1.5 cm for imaging.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Pennsylvania, Perelman Center for Advanced Medicine
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Austin Pantel, MD — University of Pennsylvania
• Study coordinator: Erin K Schubert, MS
• Email: erinschu@pennmedicine.upenn.edu
• Phone: 215-573-6569

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.