[18F]FluorThanatrace PET/CT Imaging for Ovarian Cancer

Overseen By Fiona Simpkins, MD

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Abramson Cancer Center of the University of Pennsylvania

Disqualifiers: Pregnancy, Breastfeeding, Imaging intolerance, others

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

Compensation: Varies

Number of Visits: 2

35 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore a new imaging method using [18F]FluorThanatrace, a radiotracer, to better understand and track ovarian cancer. The study involves two groups: one examines how the substance spreads through the body, and the other investigates its interaction with cancer tissues. Women with known or suspected ovarian, fallopian tube, or primary peritoneal cancer, who have at least one visible lesion on standard scans, might be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new imaging method.

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

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 imaging in ovarian cancer?

Research has shown that [18F]FluorThanatrace, a PET imaging agent, has been tested in trials for ovarian and breast cancer. These trials primarily assess its imaging effectiveness while also gathering safety data. Past studies have demonstrated that [18F]FluorThanatrace effectively targets cancer cells.

Since this trial is in an early stage, it focuses on safety and understanding how the body processes the agent. Early-stage trials involve close monitoring for any side effects, a crucial step to ensure the treatment is safe for further testing and use.

Treatments in these trials sometimes have few side effects, but this can vary. Participants receive close monitoring to quickly address any safety issues. If [18F]FluorThanatrace is being considered, it indicates an acceptable safety level in earlier tests. Always discuss any concerns with the trial team to understand the possible risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about [18F]FluorThanatrace for ovarian cancer because it offers a novel way to visualize and understand the behavior of cancer cells in the body. Unlike standard imaging techniques, which might not effectively highlight active cancer regions, [18F]FluorThanatrace uses a specially designed tracer for PET/CT scans that targets specific metabolic activities of cancer cells. This could provide more detailed and accurate imaging, potentially leading to better treatment planning and monitoring. By directly visualizing cancer activity, this approach might help doctors tailor treatments more precisely to each patient's needs.

What evidence suggests that [18F]FluorThanatrace PET/CT Imaging is effective for ovarian cancer?

Research has shown that [18F]FluorThanatrace ([18F]FTT) can measure a protein called PARP-1 in ovarian cancer. This is important because PARP-1 aids cancer cells in self-repair, and higher levels might indicate more active cancer. Studies have found that [18F]FTT PET imaging provides unique information about ovarian cancer that other common imaging methods do not. In this trial, participants will be divided into two cohorts: the Biodistribution cohort and the Dynamic cohort. In trials with other cancers, such as breast cancer, [18F]FTT specifically targeted cancer cells, demonstrating its potential to identify active tumors. These findings suggest that [18F]FluorThanatrace could be a valuable tool for understanding and detecting ovarian cancer activity. ^{1 2 3 5 6}

Who Is on the Research Team?

Fiona Simpkins, MD

Principal Investigator

Abramson Cancer Center at Penn Medicine

Are You a Good Fit for This Trial?

This trial is for women aged 18 or older with known or suspected epithelial ovarian, fallopian tube, or primary peritoneal cancer. They must have at least one lesion that's visible on standard imaging and can be either newly diagnosed or have recurrent cancer. Pregnant or breastfeeding women and those unable to tolerate imaging procedures are excluded.

Inclusion Criteria

I have or had ovarian, fallopian tube, or peritoneal cancer.

At least one lesion ≥ 1.0 cm that is seen on standard imaging (e.g. CT, MRI, ultrasound, FDG PET/CT)

Exclusion Criteria

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

Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential at screening.

My doctor thinks I have a health issue that could make participating in the study unsafe for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Biodistribution Imaging

Participants in the Biodistribution cohort undergo a series of vertex to mid-thigh biodistribution [18F]FTT PET/CT scans over approximately 4 hours

1 day

1 visit (in-person)

Dynamic Imaging

Participants in the Dynamic cohort undergo 1 static skull base to mid-thigh scan imaging post injection of [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 (FTT) is being tested in this study using PET/CT scans to understand its distribution, metabolism, and excretion in patients with gynecological cancers. The trial has two parts: a Biodistribution cohort for dosimetry calculations and a Dynamic cohort to assess FTT uptake compared to PARP-1 activity in tissues.

How Is the Trial Designed?

Group I: Dynamic Experimental Treatment 2 Interventions

The Dynamic cohort will include up to 36 patients who will undergo 1 static skull base to mid-thigh scans imaging post injection of \[18F\]FTT.

Group II: Biodistribution Experimental Treatment 2 Interventions

The Biodistribution cohort will include up to 4 patients who will undergo a series of vertex to mid-thigh biodistribution \[18F\]FTT PET/CT scans over a period of approximately 4 hours. Up to 10 subjects were initially planned for this cohort, however, the first 4 subjects have been enrolled and initial data analysis for these completed. The decision was made to close enrollment for this cohort as we do not believe that we need to complete the up to 10 subjects originally planned for this cohort as the initial data shows consistent and repeatable data that we do not believe would change significantly with the addition of 6 more subjects.

Who Is Running the Clinical Trial?

Abramson Cancer Center of the University of Pennsylvania

Lead Sponsor

Trials

360

Recruited

108,000+

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Published Research Related to This Trial

An innovative approach using (18)F-FDG PET/CT imaging and a gamma probe during surgery allows for effective localization and verification of tumor resection in patients with recurrent ovarian cancer, enhancing surgical outcomes.

In a study involving three patients, this method successfully confirmed complete resection of tumors in two cases and identified extensive unresectable disease in one case, demonstrating its potential to improve intraoperative decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel perioperative imaging with 18F-FDG PET/CT and intraoperative 18F-FDG detection using a handheld gamma probe in recurrent ovarian cancer. Cohn, DE., Hall, NC., Povoski, SP., et al.[2016]

In a study of 21 women with ovarian cancer, integrated PET/CT imaging significantly improved the localization of cancer lesions, identifying 98% of lesions with definite localization compared to only 44% with PET alone.

PET/CT also reduced the number of equivocal lesions from 51% to 11%, enhancing the accuracy of characterizing lesions as benign or malignant, which is crucial for effective staging and treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-FDG PET and PET/CT in the Localization and Characterization of Lesions in Patients with Ovarian Cancer. Caprio, MG., Capacchione, D., Mainolfi, C., et al.[2021]

This pilot study involving 14 patients demonstrated that PSMA 18F-DCFPyl PET/MR imaging can effectively detect ovarian cancer, showing significantly higher tracer uptake in malignant lesions compared to normal and benign ovarian tissues.

The results indicate that PSMA uptake is minimal in benign lesions, suggesting that this imaging technique could help differentiate between malignant and non-malignant ovarian conditions, warranting further research with larger patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distribution of prostate specific membrane antigen (PSMA) on PET-MRI in patients with and without ovarian cancer. Sadowski, EA., Lees, B., McMillian, AB., et al.[2023]

In a study of 42 patients with oesophageal cancer, high uptake of the amino-acid tracer (18)F-FAMT was linked to more advanced cancer stages and lymph node metastasis, indicating its potential as a biomarker for disease progression.

The study confirmed that (18)F-FAMT is specifically transported into tumor cells by the L-type amino-acid transporter 1 (LAT1), and its uptake correlates with cell proliferation and angiogenesis, highlighting LAT1's role in cancer metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biological significance of fluorine-18-α-methyltyrosine (FAMT) uptake on PET in patients with oesophageal cancer. Suzuki, S., Kaira, K., Ohshima, Y., et al.[2021]

In a study of 30 patients with esophageal squamous cell carcinoma, the accumulation of the PET tracer (18)F-FAMT in lymph nodes was correlated with a higher complete response rate to chemoradiotherapy, suggesting its potential as a predictive biomarker for treatment outcomes.

In contrast, (18)F-FDG accumulation did not show a similar correlation, indicating that (18)F-FAMT may be more effective in assessing lymph node involvement and predicting responses to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

L-[3-¹⁸F]-α-methyltyrosine uptake by lymph node metastasis is a predictor of complete response to CRT in esophageal cancer. Sohda, M., Miyazaki, T., Honjyo, H., et al.[2019]

Fluorodeoxyglucose positron emission tomography/computed tomography (FDG PET/CT) is a valuable imaging tool for guiding clinical management decisions in ovarian cancer patients.

FDG PET/CT is particularly effective for preoperative evaluation of primary ovarian cancer and for assessing recurrence after surgery, which can help improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PET/CT in the imaging of ovarian Cancer. O'Connor, OJ., Prakash, P., Cronin, CG., et al.[2022]

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

[18F]FluorThanatrace ([18F]FTT) PET Imaging of PARP- ... We previously showed that the PET radiotracer [18F]FluorThanatrace ([18F]FTT) measures PARP-1 expression in ovarian cancer. Herein, we demonstrate the ...

2. jnm.snmjournals.org jnm.snmjournals.org/content/66/1/34

[ 18 F]Fluorthanatrace PET in Ovarian Cancer: Comparison ... Our findings suggest that [ 18 F]FTT PET may provide unique information on ovarian cancer distinct from [ 18 F]FDG PET and commonly assessed tumor features.

3. 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, ...

4. 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.

5. withpower.com withpower.com/trial/phase-1-carcinoma-11-2018-08f54

[^18F] FLuorthanatrace PET/CT for Ovarian Cancer Trial Overview The study tests how well a radioactive tracer called Fluorine F 18 fluorthanatrace works in PET/CT scans for detecting tumor cells in various ...

6. aacrjournals.org aacrjournals.org/clincancerres/article/doi/10.1158/1078-0432.CCR-22-1602/711319/am/18F-FluorThanatrace-18F-FTT-PET-Imaging-of-PARP

[18F]FluorThanatrace ([18F]FTT) PET Imaging of PARP ... [18F]FluorThanatrace ([18F]FTT) PET Imaging of PARP-inhibitor Drug-Target Engagement as a Biomarker of Response in Ovarian Cancer, a pilot study Available.