FTT PET/CT Imaging for Breast Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Abramson Cancer Center at Penn Medicine

Disqualifiers: Pregnancy, Breastfeeding, Imaging intolerance, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 2

30 Participants Needed

Trial Summary

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 study team or your doctor.

What data supports the effectiveness of the treatment [18F]FluorThanatrace for breast cancer?

The development of 18F Fluorthanatrace as a PET radiotracer shows promise in imaging a specific protein (PARP-1) involved in breast cancer, which could help in measuring the expression levels of this protein in patients. This could potentially aid in the personalization of treatment by identifying patients who might benefit from PARP inhibitors. ^{1 2 3 4 5}

Is [18F]FluorThanatrace safe for use in humans?

The development of [18F]FluorThanatrace included first-in-human imaging studies, suggesting it has been evaluated for safety in humans, but specific safety data details are not provided in the available research. ^{3 6 7 8 9}

How does the drug FTT PET/CT Imaging for Breast Cancer differ from other treatments?

FTT PET/CT Imaging uses a special radiotracer called 18F-FTT to visualize the activity of an enzyme called PARP-1 in breast cancer, which is different from traditional treatments that focus on directly targeting cancer cells. This imaging technique helps in assessing the expression levels of PARP-1, providing a unique way to evaluate the potential effectiveness of PARP inhibitors, a class of drugs used in cancer treatment. ^{3 6 9 10 11}

What is the purpose of this trial?

Up to 30 evaluable participants with known or suspected breast cancer (BIRADS 5 by imaging) will undergo FTT PET/CT imaging before primary surgery or neoadjuvant therapy. Patients undergoing neoadjuvant therapy may choose to have a second FTT PET/CT scan after the start of therapy (1 days to 3 weeks). FTT PET/CT uptake will be correlated with pathology measures and treatment response, in subjects undergoing neoadjuvant therapy

Research Team

Elizabeth McDonald, MD

Principal Investigator

Abramson Cancer Center at Penn Medicine

Eligibility Criteria

This trial is for adults over 18 with suspected or confirmed breast cancer, showing a lesion of at least 1 cm on imaging. Participants must be willing to provide tissue samples and consent to research use. It's not suitable for those who can't tolerate imaging procedures, have conditions compromising safety/participation, or are pregnant/breastfeeding.

Inclusion Criteria

I am diagnosed or highly suspected to have primary breast cancer.

I have a breast lesion that is at least 1 cm large, confirmed by imaging.

I agree to let my biopsy or surgery samples be used for research.

Exclusion Criteria

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

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.

You cannot handle medical imaging procedures, according to your doctor's opinion.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo FTT PET/CT imaging before primary surgery or neoadjuvant therapy

1 day

1 visit (in-person)

Optional Imaging

Participants undergoing neoadjuvant therapy may choose to have a second FTT PET/CT scan after the start of therapy

1 day to 3 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging and therapy

4 weeks

Treatment Details

Interventions

• [18F]FluorThanatrace

Trial Overview [18F]FluorThanatrace (FTT) PET/CT scans are being tested in up to 30 participants before surgery or therapy for breast cancer. The study may include a second scan after starting therapy to correlate FTT uptake with pathology and treatment response.

Participant Groups

Group I: Single Arm Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Abramson Cancer Center of the University of Pennsylvania

Lead Sponsor

Trials

360

Recruited

108,000+

Findings from Research

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]

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 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]

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]

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]

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]

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

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

2. 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]

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

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

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

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

5. Germany pubmed.ncbi.nlm.nih.gov

18F-FDG PET/CT is a prognostic biomarker in patients affected by bone metastases from breast cancer in comparison with 18F-NaF PET/CT. [2015]

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. 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]

9. 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]

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

Using (18)F-FLT PET to distinguish between malignant and benign breast lesions with suspicious findings in mammography and breast ultrasound. [2016]

11. Spain pubmed.ncbi.nlm.nih.gov

[Positron emission tomography in breast cancer]. [2016]