Fluorine F 18 Fluorthanatrace PET/CT Imaging for Breast Cancer

Recruiting at 2 trial locations

Overseen By Lilie Lilie

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Breastfeeding, Prior cancer therapy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

36 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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. ^{1 6 10 11 12}

Research Team

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.

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

Group I: Treatment ([18F]FTT PET/CT) Experimental Treatment 3 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.

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.

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Positron emission tomography-computed tomography (PET-CT) using fluorine-18-fluoro-D-glucose (FDG) is particularly effective in detecting and staging primary invasive breast tumors and monitoring treatment response in locally advanced cases, allowing for early identification of nonresponders.

The use of PET-CT can help personalize breast cancer treatment by enabling timely decisions about therapy modifications, potentially reducing unnecessary chemotherapy, minimizing side effects, and lowering healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast cancer therapy: the role of PET-CT in decision making. Pons, F., Duch, J., Fuster, D.[2009]

In a study of 118 breast cancer patients, sodium fluorine-18-fluoride (F-NaF) PET/CT demonstrated high accuracy (93%) in detecting bone metastases, identifying them in 42% of cases.

The results from F-NaF PET/CT led to changes in patient management for 25% of the patients, indicating its significant impact on treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of 18F-NaF PET/CT in bone metastasis detection and its effect on patient management in patients with breast carcinoma. Broos, WAM., van der Zant, FM., Wondergem, M., et al.[2019]

The [18F]fluoro analogue of tamoxifen shows receptor-mediated uptake in breast tumors, as evidenced by decreased tumor uptake when rats were pretreated with diethylstilbestrol (DES), indicating its potential effectiveness for targeted imaging.

Both the [18F]fluoro analogue of tamoxifen and [18F]fluoroalanine demonstrated promising biodistribution profiles for imaging breast tumors, with PET imaging successfully visualizing tumors just one hour after injection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synthesis of [18F]fluoroalanine and [18F]fluorotamoxifen for imaging breast tumors. Yang, D., Kuang, LR., Cherif, A., et al.[2016]

Positron emission tomography/computed tomography (PET/CT) is a rapidly growing imaging technique in cancer management, but the commonly used radiotracer [(18)F]fluorodeoxyglucose (FDG) is not specific for malignant disease, highlighting the need for more tumor-specific PET radiopharmaceuticals.

Over the past 15 years, various alternative (18)F-labeled radiotracers have been developed and evaluated, which may provide better characterization of tumor biology, emphasizing the importance of regulatory compliance and safety in their clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

(18)F-labeled positron emission tomographic radiopharmaceuticals in oncology: an overview of radiochemistry and mechanisms of tumor localization. Vallabhajosula, S.[2022]

FDG is currently the only fluorinated tracer used in clinical PET imaging, providing high-resolution images due to its ideal properties, including low positron energy and a suitable half-life for dynamic studies.

Recent advancements in the synthesis of fluorinated tracers, particularly using prosthetic group precursors, have led to the development of both generalist and specific tracers that may enhance PET imaging in cancer patients, potentially expanding beyond the capabilities of FDG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluorinated tracers for imaging cancer with positron emission tomography. Couturier, O., Luxen, A., Chatal, JF., et al.[2018]

The newly synthesized PET radiotracer [18F]FEDBT showed a high radiochemical yield of 60% and excellent purity over 98%, indicating its potential for effective imaging in oncology.

In preclinical studies, [18F]FEDBT demonstrated significantly higher uptake in breast cancer cell lines compared to normal tissues, but further modifications are needed to reduce liver accumulation and enhance tumor targeting for better imaging results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synthesis and biological evaluation of 2-(3,4-dimethoxyphenyl)-6-(2-[18F]fluoroethoxy)benzothiazole ([18F]FEDBT) for PET imaging of breast cancer. Li, GY., Vaulina, DD., Li, JJ., et al.[2017]

[18F] FDG is currently the most effective PET imaging probe for detecting tumors, but it has limitations in identifying tumors in the brain and areas of inflammation.

The review highlights the potential of alternative 18F-labeled probes, such as FET, FLT, and FMISO, which target different biological processes like amino acid transport and hypoxia, offering complementary options for tumor imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Development of molecular imaging probes in oncology]. Iwata, R.[2016]

(18)F-FDG PET imaging is widely used for diagnosing and monitoring tumors, but it has limitations such as non-selectivity for tumors and interference from inflammatory cells, which can complicate image interpretation.

New tracers like (18)F-fluorothymidine ((18)F-FLT) and (18)F-fluorocholine ((18)F-FCH) have been developed to improve tumor imaging by targeting cell proliferation and metabolic activity, potentially offering better diagnostic capabilities for certain malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of 18F-fluorothymidine and 18F-fluorocholine in imaging with positron emission tomography]. Skoura, E., Datseris, IE.[2018]

The pilot study demonstrated that (18)F-FLT-PET can effectively visualize primary breast tumors, with a mean uptake value indicating significant tracer activity in the tumors.

While (18)F-FLT-PET detected uptake in some large axillary lymph-node metastases, it was less effective in identifying smaller metastases, suggesting limitations in its sensitivity for lymph-node evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positron emission tomography in patients with breast cancer using (18)F-3'-deoxy-3'-fluoro-l-thymidine ((18)F-FLT)-a pilot study. Been, LB., Elsinga, PH., de Vries, J., et al.[2016]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Development of 18F Fluorthanatrace: A PET Radiotracer for Imaging Poly (ADP-Ribose) Polymerase-1. [2023]

2. Japan pubmed.ncbi.nlm.nih.gov

[Imaging of cancer activity and range of tumor involvement--applying to breast cancer]. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Translation of New Molecular Imaging Approaches to the Clinical Setting: Bridging the Gap to Implementation. [2016]

4. Italy pubmed.ncbi.nlm.nih.gov

Breast cancer therapy: the role of PET-CT in decision making. [2009]

5. England pubmed.ncbi.nlm.nih.gov

Accuracy of 18F-NaF PET/CT in bone metastasis detection and its effect on patient management in patients with breast carcinoma. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Synthesis of [18F]fluoroalanine and [18F]fluorotamoxifen for imaging breast tumors. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

(18)F-labeled positron emission tomographic radiopharmaceuticals in oncology: an overview of radiochemistry and mechanisms of tumor localization. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Fluorinated tracers for imaging cancer with positron emission tomography. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Synthesis and biological evaluation of 2-(3,4-dimethoxyphenyl)-6-(2-[18F]fluoroethoxy)benzothiazole ([18F]FEDBT) for PET imaging of breast cancer. [2017]

10. Japan pubmed.ncbi.nlm.nih.gov

[Development of molecular imaging probes in oncology]. [2016]

11. Greece pubmed.ncbi.nlm.nih.gov

[The use of 18F-fluorothymidine and 18F-fluorocholine in imaging with positron emission tomography]. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Positron emission tomography in patients with breast cancer using (18)F-3'-deoxy-3'-fluoro-l-thymidine ((18)F-FLT)-a pilot study. [2016]