36 Participants Needed

Fluorine F 18 Fluorthanatrace PET/CT Imaging for Breast Cancer

Recruiting at 2 trial locations
LL
Overseen ByLilie Lilie
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This phase II trial tests whether \[18F\]FluorThanatrace by positron emission tomography (PET)/computed tomography (CT) can improve imaging techniques in patients with breast cancer undergoing a standard of care biopsy or surgery. \[18F\]FluorThanatrace is a new radioactive tracer, which is a type of imaging agent that is labeled with a radioactive tag and injected into the body to help with imaging scans. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, \[18F\]FluorThanatrace. Because some cancers take up \[18F\]FluorThanatrace it can be seen with PET. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. \[18F\]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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are undergoing any current or prior therapy for breast cancer, you may not be eligible to participate.

What data supports the effectiveness of the treatment Fluorine F 18 Fluorthanatrace for breast cancer?

Fluorine 18 fluorthanatrace (18F-FTT) is a PET radiotracer that helps image a protein called PARP-1, which is important in breast cancer. Initial studies have shown it can measure PARP-1 levels in breast cancer patients, suggesting it might help in understanding the disease better.12345

Is Fluorine F 18 Fluorthanatrace safe for use in humans?

Fluorine 18 (18F) fluorthanatrace has been evaluated in early human imaging studies, and while the research primarily focuses on its development and potential as an imaging tool, it does not report any specific safety concerns in humans.16789

How is Fluorine F 18 Fluorthanatrace PET/CT Imaging unique for breast cancer treatment?

Fluorine F 18 Fluorthanatrace is unique because it is a PET radiotracer specifically designed to image PARP-1, a protein involved in DNA repair, which is a target for certain breast cancer drugs. This imaging technique helps visualize the expression levels of PARP-1 in breast cancer, providing a novel way to assess the presence and activity of this protein in tumors.16101112

Research Team

LL

Lilie L Lilie

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults over 18 with breast cancer who are candidates for primary breast surgery and have a tumor of at least 1.0 cm visible on imaging. It's not for those pregnant, breastfeeding, previously treated for their breast cancer, unable to tolerate imaging procedures, or with conditions that may compromise safety or participation.

Inclusion Criteria

Participants must be informed of the investigational nature of this study and provide written informed consent, in accordance with institutional and federal guidelines prior to study-specific procedures
I am a candidate for surgery to remove breast cancer.
My breast cancer has a tumor that is at least 1.0 cm big, confirmed by imaging.

Exclusion Criteria

I have received treatment for my primary breast cancer.
I don't have any health issues that a doctor thinks would make the study unsafe for me.
I am not pregnant or breastfeeding.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Participants receive [18F]FTT intravenously and undergo PET/CT scan over 20-30 minutes

1 day
1 visit (in-person)

Optional Follow-up Imaging

Participants may undergo an optional PET/CT scan 1 week after the baseline scan

1 week
1 visit (in-person, optional)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

Treatment Details

Interventions

  • Fluorine F 18 Fluorthanatrace
Trial Overview [18F]FluorThanatrace by PET/CT is being tested to see if it can improve imaging in patients undergoing biopsy or surgery for breast cancer. This new radioactive tracer might help detect enzyme activity related to cancer growth when used with PET/CT scans.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment ([18F]FTT PET/CT)Experimental Treatment3 Interventions
Patients receive \[18F\]FTT IV over a few seconds to a minute and then undergo PET/CT scan over 20-30 minutes at baseline and another optional scan 1 week later. During the \[18F\]FTT PET/CT scan patients.

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+

Trevarx Biomedical, Inc

Collaborator

Trials
1
Recruited
40+

Findings from Research

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]
Fluorine-18 fluorodeoxyglucose (FDG) PET imaging is highly effective in managing breast cancer, providing crucial information for diagnosis, staging, and monitoring treatment that traditional imaging methods cannot offer.
FDG-PET is particularly valuable for postoperative monitoring and predicting prognosis, and future advancements with new tracers and imaging technologies like PET-CT and PEM are expected to enhance breast cancer management even further.
[Imaging of cancer activity and range of tumor involvement--applying to breast cancer].Shibata, K., Uno, K., Wu, J., et al.[2016]
Molecular imaging with PET is becoming increasingly important in breast cancer, with over 45 different PET tracers being tested, but currently only (18)F-FDG is widely used in clinical guidelines.
To effectively implement new PET tracers in clinical practice, standardization of technology and access to these tracers is essential, along with innovative research approaches to demonstrate their clinical value with fewer patients.
Translation of New Molecular Imaging Approaches to the Clinical Setting: Bridging the Gap to Implementation.van Es, SC., Venema, CM., Glaudemans, AW., et al.[2016]

References

The Development of 18F Fluorthanatrace: A PET Radiotracer for Imaging Poly (ADP-Ribose) Polymerase-1. [2023]
[Imaging of cancer activity and range of tumor involvement--applying to breast cancer]. [2016]
Translation of New Molecular Imaging Approaches to the Clinical Setting: Bridging the Gap to Implementation. [2016]
Breast cancer therapy: the role of PET-CT in decision making. [2009]
Accuracy of 18F-NaF PET/CT in bone metastasis detection and its effect on patient management in patients with breast carcinoma. [2019]
Synthesis of [18F]fluoroalanine and [18F]fluorotamoxifen for imaging breast tumors. [2016]
(18)F-labeled positron emission tomographic radiopharmaceuticals in oncology: an overview of radiochemistry and mechanisms of tumor localization. [2022]
Fluorinated tracers for imaging cancer with positron emission tomography. [2018]
Synthesis and biological evaluation of 2-(3,4-dimethoxyphenyl)-6-(2-[18F]fluoroethoxy)benzothiazole ([18F]FEDBT) for PET imaging of breast cancer. [2017]
[Development of molecular imaging probes in oncology]. [2016]
[The use of 18F-fluorothymidine and 18F-fluorocholine in imaging with positron emission tomography]. [2018]
Positron emission tomography in patients with breast cancer using (18)F-3'-deoxy-3'-fluoro-l-thymidine ((18)F-FLT)-a pilot study. [2016]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceยทPrivacy PolicyยทCookiesยทSecurity