PARP Imaging with [18F]Florathanatrace for Cancer

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Washington University School of Medicine

Disqualifiers: Claustrophobia, Implanted device, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to detect cancer activity using PET scans with a special tracer called [18F]FluorThanatrace (a radiotracer). The aim is to determine if this tracer can help doctors better understand cancer by highlighting activity related to the protein PARP-1. The trial has two parts: one examines how the tracer moves in the body, involving both cancer patients and healthy volunteers, while the other assesses how the tracer behaves in tumors, involving only cancer patients. Individuals with head and neck, lung, or other cancers treated with platinum-based chemotherapy might be suitable candidates, especially if they have a tumor at least 1 cm in size. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative tracer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that [18F]FluorThanatrace is safe for PET imaging in cancer patients?

Research has shown that [18F]FluorThanatrace, a new imaging tracer, has been tested in early studies with patients who have breast and ovarian cancer. These studies used the tracer to visualize an enzyme linked to cancer growth. Although detailed safety information from these studies is limited, the tracer's progression to human testing suggests it was generally well-tolerated in earlier tests.

As this study is in an early phase, researchers are closely monitoring the tracer's safety in humans. Specific side effects from earlier studies have not been detailed. However, advancing to human trials usually indicates some initial confidence in its safety from prior tests. So far, no major safety concerns have emerged with [18F]FluorThanatrace, but ongoing trials will provide more information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about [18F]FluorThanatrace because it offers a new way to visualize cancer activity using PET/CT imaging. Unlike current treatments that often rely on invasive biopsies to understand tumor dynamics, [18F]FluorThanatrace is a radiotracer that highlights PARP enzyme activity directly in the body. This method allows for real-time insights into tumor behavior and metabolism, potentially leading to more precise and personalized treatment strategies. By providing a clearer picture of how cancer cells are functioning, this approach could revolutionize how doctors monitor and adapt cancer treatment plans.

What evidence suggests that this imaging technique is effective for cancer?

Research has shown that \[18F\]FluorThanatrace (\[18F\]FTT) effectively images cancer by targeting a protein called PARP-1, which aids in DNA repair. Studies have found that \[18F\]FTT can highlight PARP-1 activity in breast and ovarian cancer and detect PARP-1 in prostate cancer, making it a promising tool for visualizing various tumors. In this trial, participants in the Dosimetry Studies Arm will undergo whole-body PET/CT imaging to determine the whole-body dosimetry of \[18F\]FTT. Meanwhile, participants in the Kinetic Studies Arm will undergo a 1-hour dynamic scan to determine the tracer's kinetics in tumors. This imaging method helps doctors assess cancer cell activity, potentially guiding treatment decisions. Overall, \[18F\]FTT holds promise for enhancing the understanding and management of cancer through PET imaging. ^{3 5 6 7 8}

Who Is on the Research Team?

Farrokh Dehdashti, M.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults with a tumor at least 1 cm in size, or healthy volunteers without cardiopulmonary issues (for different study arms). It's open to those with certain cancers treatable by platinum-based chemo. People can't join if they can't follow the study plan, stay still in a PET/CT scanner, have incompatible implants, non-measurable disease under 1 cm, or conditions like claustrophobia that prevent imaging sessions.

Inclusion Criteria

I have a tumor that is at least 1 cm wide, confirmed by a CT scan.

I am healthy, don't smoke, and have no heart or lung issues needing treatment.

I have been diagnosed with a type of cancer that can be treated with platinum-based chemotherapy.

Exclusion Criteria

Presence of an implanted device that is incompatible with CT scanning

I understand and am willing to follow the study's instructions.

You have a history of feeling very uncomfortable or anxious in small spaces, like an MRI machine, or any other condition that would make it difficult for you to complete required imaging sessions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dosimetry Studies

Participants undergo whole-body PET/CT imaging to determine the whole body dosimetry of [18F]FluorThanatrace

1 week

1 visit (in-person)

Kinetic Studies

Participants undergo a 1-hour dynamic scan upon injection of [18F]FluorThanatrace to determine the kinetics of the tracer in tumors

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging studies

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• [18F]FluorThanatrace

Trial Overview

[18F]FluorThanatrace ([18F]FTT), a new radioactive tracer for PET scans, is being tested to see if it can effectively image cancer activity related to an enzyme called PARP-1. The trial will assess how well this compound works for visualizing tumors in patients.

How Is the Trial Designed?

Group I: Kinetic Studies Arm Experimental Treatment 1 Intervention

An additional 30 participants with cancer will undergo a 1-hour dynamic scan upon injection of \[18F\]FluorThanatrace to determine the kinetics of the tracer in tumors to correlate with tissue-based markers of PARP activity and to obtain metabolite information to help determine the best quantification approach for the PET images. When possible these subjects will also undergo 18F-FDG imaging for comparison to tumor metabolism

Group II: Dosimetry Studies Arm Experimental Treatment 1 Intervention

Twelve participants with cancer and eight healthy volunteers will be recruited first to undergo whole-body PET/CT imaging to determine the whole body dosimetry of \[18F\]FluorThanatrace.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

The study evaluated [18F]FluorThanatrace ([18F]FTT) as a biomarker to predict response to PARP inhibitors in homologous recombination deficient high-grade serous ovarian cancer, showing that a decrease in [18F]FTT uptake after treatment correlated with positive responses in patient-derived xenograft models and in 11 subjects.

In patients, a significant reduction in [18F]FTT uptake after about a week of PARP inhibitor treatment was associated with improved tumor response and progression-free survival, indicating that [18F]FTT could be a valuable tool for guiding PARP inhibitor therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[18F]FluorThanatrace ([18F]FTT) PET Imaging of PARP-Inhibitor Drug-Target Engagement as a Biomarker of Response in Ovarian Cancer, a Pilot Study. Pantel, AR., Gitto, SB., Makvandi, M., et al.[2023]

The development of the PET radiotracer 18F-FTT for imaging PARP-1 has progressed from preclinical evaluation to first-in-human studies, showing promise as a biomarker for measuring PARP-1 levels in breast and ovarian cancer patients.

The article outlines the regulatory process for submitting an investigational new drug application to the FDA and emphasizes the need for a commercialization strategy to facilitate multicenter clinical trials for future approval.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Development of 18F Fluorthanatrace: A PET Radiotracer for Imaging Poly (ADP-Ribose) Polymerase-1. Lee, HS., Schwarz, SW., Schubert, EK., et al.[2023]

Citations

1.

nature.com

nature.com/articles/s43856-025-00791-0

[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.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8830434/

A PET Radiotracer for Imaging Poly (ADP-Ribose) Polymerase-1

Fluorine 18 fluorthanatrace(18F-FTT) showed PARP-1 specific uptake in preclinical models of cancer. □ In both ovarian and breast cancer trials, ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06502691

Study Details | NCT06502691 | [18F]FTT Positron Emission ...

This clinical trial studies how well fluorine F 18 fluorthanatrace ([18F]FTT) positron emission tomography (PET) works in imaging patients with breast cancer ...

4.

aacrjournals.org

aacrjournals.org/cancerres/article/83/7_Supplement/5610/723266/Abstract-5610-18F-FluorThanatrace-18F-FTT-PET

Abstract 5610: [18F]FluorThanatrace ([18F]FTT) PET Imaging ...

Results: A decrease in FTT tumor uptake after 1 week of PARPi ... [18F]FluorThanatrace ([18F]FTT) PET Imaging of PARP-inhibitor drug ...

5.

jnm.snmjournals.org

jnm.snmjournals.org/content/63/supplement_2/2267

Evaluation of in vivo PARP-1 Expression with 18F ...

Conclusions: [18F]FTT is able to detect in vivo PARP-1 expression in localized, clinically significant prostate cancer. This tracer may be used ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05226663

A Radiotracer ([18F]FluorThanatrace) by PET/CT for the ...

[18F]FluorThanatrace by PET/CT may help detect the activity of a certain enzyme in the body that may be related to cancer growth in patients with breast cancer.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12012890/

[18F]FluorThanatrace ([18F]FTT) PET Imaging of PARP- ...

We first explore [18F]FTT in pre-clinical models of ovarian cancer using patient derived xenografts (PDX), followed by pilot data from a phase 2 clinical trial ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06502691

Study Details | NCT06502691 | [18F]FTT Positron Emission ...

This clinical trial studies how well fluorine F 18 fluorthanatrace ([18F]FTT) positron emission tomography (PET) works in imaging patients with breast cancer ...