[18F]FluorThanatrace for Pancreatic Cancer

Overseen By Erin K Schubert, MS

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Abramson Cancer Center at Penn Medicine

Disqualifiers: Pregnancy, Breastfeeding, Liver therapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new PET imaging agent called [18F]FluorThanatrace to evaluate its effectiveness in showing the activity of a protein called PARP-1 in pancreatic neuroendocrine tumors. The goal is to determine if this imaging method can improve tumor assessment. It uses a special type of scan (PET/CT) to capture images of the tumors after injecting this agent. Individuals with pancreatic neuroendocrine tumors that have spread or cannot be surgically removed, and who have at least one tumor 1.5 cm or larger on a scan, might be suitable for this trial. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new imaging agent.

Do I have to stop taking my current medications for the trial?

The trial does not specify whether you need to stop taking your current medications. It seems you can continue your current treatment while participating.

What prior data suggests that this PET imaging agent is safe for use in humans?

Research has shown that the new PET imaging agent [18F]FluorThanatrace ([18F]FTT) is under study for its interaction with pancreatic cancer. In studies involving other cancer types, [18F]FTT has been used without reports of serious side effects. The highest activity in men appeared in the pancreas, but the radiation level was low, averaging 0.0339 mSv/MBq, suggesting the treatment is quite tolerable.

As this study is in its early stages, it focuses on understanding how the treatment functions in the body. Safety remains a primary concern, and while detailed human safety data may be limited, early research findings are promising. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about [18F]FluorThanatrace for pancreatic cancer because it offers a novel approach to imaging, which is crucial for diagnosing and monitoring this aggressive disease. Unlike standard imaging techniques, [18F]FluorThanatrace uses a radioactive tracer that targets specific tumor markers, potentially providing clearer and more detailed images. This precision could help detect tumors earlier and evaluate treatment responses more effectively. The dynamic PET/CT imaging approach also allows for real-time tracking of the tracer, which may lead to better personalized treatment strategies for patients.

What evidence suggests that [18F]FluorThanatrace is effective for pancreatic cancer?

Research has shown that \[18F\]FluorThanatrace (\[18F\]FTT) is being tested in this trial as a PET scan agent to assess the activity of the PARP-1 enzyme in tumors. This enzyme is often active in cancer cells, making it a useful target for detecting tumor activity. Studies in other cancers, such as breast cancer, have demonstrated that \[18F\]FTT can effectively highlight areas with high PARP-1 activity. This is important because it helps indicate the level of cancer cell activity. Although specific data on its effectiveness in pancreatic neuroendocrine tumors is still being gathered, its mechanism suggests it could be promising for identifying and possibly monitoring these tumors. ^{2 3 4 6 7}

Who Is on the Research Team?

Austin Pantel, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for patients with pancreatic neuroendocrine tumors. It's a small study, aiming to enroll just 12 people. Participants will undergo specialized PET CT scans using a new imaging agent called [18F]FluorThanatrace ([18F]FTT).

Inclusion Criteria

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

Have at least one lesion on clinical imaging (e.g. CT/MRI/PET/CT/ultrasound) that is ≥ 1.5 cm in size

I may or may not be currently undergoing treatment for my condition.

Exclusion Criteria

I am not pregnant or breastfeeding.

Inability to tolerate imaging procedures in the opinion of an investigator or treating physician

I've had liver therapy that targeted all my cancer without it getting worse.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Assessment

Participants undergo a study imaging assessment using a whole-body PET CT scanner with [18F]FTT

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• [18F]FluorThanatrace

Trial Overview [18F]FluorThanatrace ([18F]FTT), a novel PET imaging agent, is being tested to see how well it shows the activity of PARP-1, an important protein in these tumors. Patients will receive an injection of this agent before their scan.

How Is the Trial Designed?

Group I: 18F-FTT PET/CT Experimental Treatment 1 Intervention

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 at approximately 90 minutes post injection will subsequently be obtained. 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.

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Citations

1. trialx.com trialx.com/clinical-trials/listings/325408/ftt-petct-in-pancreatic-neuroendocrine-tumors/

FTT PET/CT in Pancreatic Neuroendocrine Tumors Eight patients with cancer and 8 patients without cancer received [18F]FTT PET/CT scans with mean 374MBq ± 19 (range 348-403 MBq). The highest ...

2. withpower.com withpower.com/trial/phase-1-pancreatic-neoplasms-8-2025-1642e

[18F]FluorThanatrace for Pancreatic Cancer This trial is for patients with pancreatic neuroendocrine tumors. It's a small study, aiming to enroll just 12 people. Participants will undergo specialized PET ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11937411/

[18F]FluorThanatrace PET imaging as a biomarker of ... Here, we evaluate a radiolabeled PARPi, [ 18 F]FluorThanatrace ([ 18 F]FTT), as a functional biomarker of PARPi response in breast cancer.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02469129

NCT02469129 | PET Imaging of PARP Activity in Cancer Our data in cancer models show that the uptake of our compound is specific for PARP1 activity and correlates with biochemically determined PARP1 activity.

5. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2018-02446

Evaluating PARP-1 Activity Using 18F-FluorThanatrace ... This pilot, early phase I trial studies how well 18F-FluorThanatrace positron emission tomography/computed tomography (PET/CT) scans work before and after ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03492164

In Vivo PARP-1 Expression With 18F-FTT PET/CT in ... 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.

7. ancora.ai ancora.ai/fr/detailsradiopharm/NCT07114939

FTT PET/CT in Pancreatic Neuroendocrine Tumors [18F]FTT uptake will be measured on the PET scan and correlated with two molecular outcomes. Show Detailed Description.