FTT PET/CT imaging to detect PARP‑1 in pancreatic neuroendocrine tumors
PARP-1 Targeting With the Novel Radiotracer [18F]FTT in Pancreatic Neuroendocrine Tumors
This pilot will test whether an experimental PET tracer called [18F]FTT can show PARP‑1 activity in adults with metastatic or unresectable grade 1–3 pancreatic neuroendocrine tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abramson Cancer Center at Penn Medicine Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT07114939 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with metastatic or unresectable grade 1–3 pancreatic neuroendocrine tumors who have at least one lesion ≥1.5 cm and are willing to provide or allow access to tumor tissue would be ideal candidates.
Not a fit: Patients whose tumors lack PARP‑1 expression, who do not have lesions large enough for reliable imaging, or who have had liver‑directed therapy that treated all disease without progression may not receive benefit from this imaging approach.
Why it matters
Potential benefit: If successful, the scan could identify tumors with PARP‑1 activity and help select patients who might benefit from PARP inhibitor therapy.
How similar studies have performed: PARP‑1 PET tracers such as [18F]FTT have shown promise in preclinical models and early human work in other cancers, but applying this imaging approach to pancreatic neuroendocrine tumors is largely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Philadelphia, Pennsylvania
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.