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NCT03492164 · ClinicalTrials.gov registry record · Early Phase 1
In Vivo PARP-1 Expression With 18F-FTT PET/CT in Pancreatic Cancer
A Early Phase 1 study, sponsored by Abramson Cancer Center at Penn Medicine.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 6
- Enrollment target
NCT03492164: Clinical Trial Early Phase 1 study, sponsored by Abramson Cancer Center at Penn Medicine.
NCT03492164 is a Early Phase 1 study that was terminated before completion, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 6 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03492164, a Early Phase 1 study, was terminated before completion, sponsored by Abramson Cancer Center at Penn Medicine.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
The investigators plan to enroll 30 evaluable patients with (1) a histological diagnosis of advanced pancreatic ductal adenocarcinoma who have demonstrated at least stable disease following ≥16 weeks of treatment with platinum-based chemotherapy and (2) who have signed consent to participate in a clinical trial that contains PARP inhibitor therapy and are anticipated to receive this treatment or (3) will receive PARP inhibitor therapy as part of their clinical care. A pre-treatment 18F-FluorThanatrace (\[18F\]FTT) positron emission tomography/computed tomography (PET/CT) scan will be done prior to the start of treatment with a PARP inhibitor. PET/CT imaging will be used to evaluate PARP-1 expression in sites of pancreatic cancer using the investigational radiotracer \[18F\]FTT. This is an observational study in that \[18F\]FTT PET/CT will not be used to direct treatment decisions. While patients and referring physicians will not be blinded to the \[18F\]FTT PET/CT results, treatment decisions will be made by the treating physicians based upon clinical criteria. Patients will undergo approximately 60 minutes of dynamic scanning starting at the time of injection of \[18F\]FTT. This procedure will be followed by a skull base to mid-thigh scan, starting at approximately 60 minutes post injection. PET/CT imaging sessions will include an injection of approximately 10 mCi (approximate range for most studies is anticipated to be 8-12 mCi) of \[18F\]FTT. Data will be collected to evaluate uptake of \[18F\]FTT in sites of pancreatic cancer, which will be compared with PARP-1 expression in tissue, when available. All 30 evaluable patients are expected to start PARP inhibitor therapy following the \[18F\]FTT PET/CT scan. It is expected that due to patient preference and time considerations, approximately 24 patients (80%) will also undergo a second (optional) scan that will be performed approximately 3 weeks (± 1 week) after therapy has started. The second scan is obtained
Interventions
- DRUG [18F]FluorThanatrace ([18F]FTT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2018-03-20 |
| Est. Completion | 2024-06-11 |
| Phase | Early Phase 1 |
Why NCT03492164 stopped before completion
NCT03492164 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which [18F]FluorThanatrace ([18F]FTT) is the first listed.
NCT03492164 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03492164 about?
NCT03492164 is a clinical study titled "In Vivo PARP-1 Expression With 18F-FTT PET/CT in Pancreatic Cancer". The investigators plan to enroll 30 evaluable patients with (1) a histological diagnosis of advanced pancreatic ductal adenocarcinoma who have demonstrated at least stable disease following ≥16 weeks of treatment with platinum-based chemotherapy and (2) who have signed consent to participate in a cl...
What is the current status of trial NCT03492164?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 6 participants. The study started on 2018-03-20. Estimated completion is 2024-06-11.
What interventions are being tested in trial NCT03492164?
The interventions under investigation include: [18F]FluorThanatrace ([18F]FTT) (DRUG).
Who is sponsoring clinical trial NCT03492164?
This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 402 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03492164's enrollment target sits among peer trials
6 1845th of 2000 higher than 114 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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