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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging method called FTT PET/CT to evaluate its effectiveness for individuals with known or suspected breast cancer. The goal is to compare the imaging results with the cancer's appearance under a microscope and its response to treatment. Participants will undergo this special scan before surgery or other treatments, and possibly again after starting treatment. The trial seeks adults with a breast lesion (lump) at least 1 cm in size, as shown by any standard imaging method, such as a mammogram or ultrasound. 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 benefit from 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 study team or your doctor.

What prior data suggests that FTT PET/CT imaging is safe for breast cancer patients?

Research has shown that [18F]FluorThanatrace is under study to aid in imaging breast cancer. This process uses a PET/CT scan to assess the activity of certain enzymes in the body, which might relate to cancer growth. So far, studies have primarily evaluated the effectiveness of this imaging technique, rather than its safety. However, in a Phase 1 trial, the main focus often lies in assessing safety and tolerability.

Earlier research with similar imaging methods has not raised major safety concerns. This type of imaging is generally well-tolerated, but any new method or substance can carry risks. If [18F]FluorThanatrace resembles other PET/CT imaging agents, it might be considered relatively safe, but confirming this is the main goal of this phase. Prospective participants should discuss any concerns with their doctor before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

[18F]FluorThanatrace is unique because it uses a radioactive tracer that specifically targets apoptosis, or programmed cell death, in breast cancer cells. While most imaging techniques for breast cancer rely on anatomical changes, this new method has the potential to highlight biochemical changes, offering a more detailed picture of how the cancer is responding to treatment. Researchers are excited about [18F]FluorThanatrace because it could provide earlier and more accurate insights into treatment effectiveness, potentially leading to more personalized and effective care for patients.

What evidence suggests that FTT PET/CT imaging is effective for breast cancer?

Studies have shown that [18F]FluorThanatrace ([18F]FTT) is a promising tool for imaging breast cancer. It acts as a biomarker, highlighting cancer cells during scans. Research indicates that [18F]FTT can better detect tumor cells, especially in patients receiving certain cancer treatments. The tracer targets a specific protein, allowing doctors to assess treatment effectiveness. Although still in early research stages, [18F]FTT has shown potential to improve imaging techniques, potentially leading to better treatment decisions. ^{1 5 6 7 8}

Who Is on the Research Team?

Elizabeth McDonald, MD

Principal Investigator

Abramson Cancer Center at Penn Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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) 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]

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 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]

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]

Citations

1. 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.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06502691

Study Details | NCT06502691 | [18F]FTT Positron Emission ... Combining [18F]FTT with a PET scan may help detect tumor cells better in patients with metastatic breast cancer who are receiving standard of care PARP ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8830434/

A PET Radiotracer for Imaging Poly (ADP-Ribose) Polymerase-1 These studies indicate that 18F-FTT has the potential to measure target engagement of PARPi, a key step in determining the therapeutic efficacy ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05226663

A Radiotracer ([18F]FluorThanatrace) by PET/CT for the ... This phase II trial tests whether [18F]FluorThanatrace by positron emission tomography (PET)/computed tomography (CT) can improve imaging techniques in patients ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40133542/

[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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11937411/

[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.

7. 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.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06502691

Study Details | NCT06502691 | [18F]FTT Positron Emission ... This clinical trial studies how well fluorine F 18 fluorthanatrace ([18F]FTT) positron emission tomography (PET) works in imaging patients with breast cancer ...