300 Participants Needed

[^18F] FLuorthanatrace PET/CT for Ovarian Cancer

LL
Overseen ByLilie Lin
Age: 18+
Sex: Female
Trial Phase: Phase 1
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging method for detecting cancer cells in individuals with ovarian, fallopian tube, or primary peritoneal cancer. The key component is a special imaging agent called fluorine F 18 fluorthanatrace, which is injected to help the PET/CT scanner produce clearer images of tumors. The goal is to determine if this method identifies more tumor cells than current techniques. Suitable candidates have a known or suspected solid tumor and at least one tumor visible on standard imaging scans. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative imaging method.

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 team or your doctor.

What prior data suggests that fluorine F 18 fluorthanatrace is safe for imaging in patients with solid tumors?

Research has shown that Fluorine F 18 Fluorthanatrace, a special imaging substance, has been tested in ovarian and breast cancer studies. These studies suggest it can target specific proteins in cancer cells, enhancing imaging results.

This trial phase primarily checks if patients can manage the side effects. As a Phase 1 trial, it assesses safety and side effects in a small group, so detailed safety information may still be limited. However, the goal is to ensure any side effects remain manageable. For participants, the main focus is on confirming the treatment's safety before advancing to further stages.12345

Why are researchers excited about this trial?

Researchers are excited about using Fluorine F 18 Fluorthanatrace in ovarian cancer imaging because it offers a unique way to visualize the disease. Unlike standard imaging methods like FDG PET/CT that highlight glucose metabolism, Fluorine F 18 Fluorthanatrace targets a specific protein involved in DNA repair, which is often elevated in cancer cells. This could provide more precise information about tumor biology, potentially leading to better-targeted treatments. Additionally, the distinct mechanism of action may help detect cancer earlier and monitor treatment response more effectively.

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

Research has shown that Fluorine F 18 fluorthanatrace, a type of radioactive tracer, could be useful in detecting ovarian cancer. This tracer targets a specific enzyme called PARP-1, often found in cancer cells. Studies have found that the tracer's presence links to PARP-1 in ovarian tumors, suggesting it might help doctors identify cancer cells more accurately. In this trial, participants will receive Fluorine F 18 fluorthanatrace and undergo [18F]FTT PET/CT imaging. Early results from trials in both ovarian and breast cancer suggest it could be effective for imaging.12678

Who Is on the Research Team?

Lilie L. Lin | MD Anderson Cancer Center

Lilie L. Lin

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with solid tumors, such as ovarian, fallopian tube, or primary peritoneal cancer. Participants must have at least one tumor lesion of 1.0 cm visible on standard imaging. Pregnant or breastfeeding women and those unable to tolerate imaging procedures are excluded.

Inclusion Criteria

I have or might have had a solid tumor in the past.
You have at least one abnormal spot that can be seen on a regular scan like CT or MRI and is at least 1.0 cm in size.

Exclusion Criteria

Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.
I am not pregnant or breastfeeding.
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 participation in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants receive FDG IV and undergo FDG PET/CT scan, followed by fluorine F 18 fluorthanatrace IV and [18F]FTT PET/CT

1 week
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

24 hours
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Fluorine F 18 Fluorthanatrace
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 cancers. It's a phase I trial focused on the effectiveness of this novel radiotracer in detailed body imaging.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (FDG PET/CT, [18F]FTT PET/CT)Experimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

18F-FDG PET CT is increasingly used in clinical settings to assess ovarian, cervical, and endometrial cancers, providing significant benefits in staging, treatment selection, and early detection of recurrence.
Despite its growing use, the application of 18F-FDG PET CT does not always align with existing guidelines and expert recommendations, highlighting a need for better integration of this imaging technique in clinical practice.
The role of 18F-FDG PET CT in common gynaecological malignancies.Narayanan, P., Sahdev, A.[2018]
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.
[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.
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

A PET Radiotracer for Imaging Poly (ADP-Ribose) Polymerase-1Fluorine 18 fluorthanatrace(18F-FTT) showed PARP-1 specific uptake in preclinical models of cancer. □ In both ovarian and breast cancer trials, ...
[^18F] FLuorthanatrace PET/CT for Ovarian CancerTrial 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 ...
Clinical Trials Using Fluorine F 18 Fluorthanatrace - NCINCI supports clinical trials that test new and more effective ways to treat cancer. Find clinical trials studying fluorine f 18 fluorthanatrace.
[F]FluorThanatrace ([F]FTT) PET Imaging of PARP-Inhibitor ...In ovarian cancer, [ 18 F]FTT uptake has been shown to correlate with ex vivo tumor measures of PARP1 expression (21,25). Early human studies ...
[18F]F-Poly(ADP-Ribose) Polymerase Inhibitor ...In this review, we discuss 18 F-Fluorine PARP inhibitor radiotracers and their potential in the imaging of PARP expression and PARP inhibitor pharmacokinetics.
Serial Imaging of the Novel Radiotracer [^18F] ...PET/CT with Fluorine F 18 fluorthanatrace may allow more tumor cells to be found in patients with ovarian, fallopian tube, or primary peritoneal ...
Pharmacodynamic Activity of [18F]-Fluorthanatrace Poly(ADP ...We tested the ability of [18F] fluorthanatrace (FTT), a radiolabeled analog of poly(ADP-ribose) polymerase (PARP)-1 inhibitors, to demonstrate target engagement ...
Fluorine F 18 Fluorthanatrace PET/CT for Imaging of ...PET/CT with Fluorine F 18 fluorthanatrace may help detect the activity of a certain enzyme in the body that may be related to cancer growth. Eligibility ...
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