PEM vs Liquid Biopsy for Breast Cancer

Overseen By Samira Taeb, MSc

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Pregnancy, Breast-feeding, Allergies to F-18 FDG, others

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

Compensation: Varies

Number of Visits: 1

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two experimental methods, Liquid Biopsy and Positron Emission Mammography (PEM), to help doctors identify and understand breast abnormalities in women at high risk of breast cancer. Liquid Biopsy, a blood test, can detect early signs of cancer, while PEM uses a special camera to locate tumors in the breast. The goal is to determine if these tests can reduce unnecessary biopsies and lessen anxiety for those at high risk. Women scheduled for an MRI-guided biopsy due to suspicious findings on a screening exam may be eligible to join this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that may improve early detection methods for breast cancer.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these tests are safe for detecting breast cancer?

Studies have shown that Liquid Biopsy, a blood test used to detect early tumors, is generally safe for patients. It involves taking a small amount of blood, similar to a regular blood test, and does not cause serious side effects.

Research indicates that Positron Emission Mammography (PEM) is also well-tolerated. It uses a small amount of a special substance called 18F-FDG, injected to highlight areas during the scan. Studies have found this amount effective for detecting breast cancer while keeping radiation exposure low.

Overall, current research considers both Liquid Biopsy and PEM safe. They are well-tolerated, with few reports of negative effects. Participants can feel reassured knowing these methods have undergone safety testing. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Liquid Biopsy and Positron Emission Mammography (PEM) for breast cancer detection because these methods offer unique advantages over traditional approaches like mammography and tissue biopsy. Liquid biopsy is minimally invasive, requiring only a blood sample, which can be a game-changer for ongoing monitoring and early detection without the need for surgical intervention. On the other hand, PEM provides detailed metabolic information by using a small injection of F-18 FDG, potentially identifying cancerous changes more accurately than standard imaging techniques. Together, these innovative methods could improve early detection and personalized treatment planning, making breast cancer management more effective and less burdensome for patients.

What evidence suggests that this trial's tests could be effective for breast cancer?

This trial will compare Liquid Biopsy with Positron Emission Mammography (PEM) for breast cancer detection. Research has shown that Liquid Biopsy is gaining popularity in managing breast cancer, as it can detect early tumors by identifying cancer-related particles in the blood. This simple, non-invasive method helps track the disease and customize treatments. Meanwhile, studies have demonstrated that PEM can accurately detect breast tumors. Specifically, one study showed that PEM identified 96% of known cancers, proving it to be a reliable imaging tool. PEM uses a small amount of a special substance to make tumors visible, aiding in early and accurate cancer detection. Both technologies, evaluated in this trial, offer promising ways to detect breast cancer early and may help reduce unnecessary biopsies. ^{1 2 5 6 7}

Who Is on the Research Team?

Vivianne Freitas, MD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

This trial is for women at high risk of breast cancer who are due to have an MRI-guided biopsy for a suspicious breast lesion. Participants will undergo two experimental tests: a blood test called Liquid Biopsy and an imaging exam known as Positron Emission Mammography (PEM).

Inclusion Criteria

I am older than 18 years.

I can understand and am willing to sign the consent form.

I am scheduled for an MRI-guided biopsy due to high-risk lesions found during screening.

Exclusion Criteria

High-risk individuals with screening-imaging studies without suspicious lesions detected by the standard of care mammogram and/or MRI

Individuals who are pregnant or who think they may be pregnant

Individuals who are breast-feeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo a blood draw for Liquid Biopsy and a PEM imaging exam before an MRI-guided biopsy

1 day

1 visit (in-person)

Follow-up

Follow-up blood and tissue samples may be requested post-surgery if malignancy is confirmed

Varies

Outcome Evaluation

Evaluation of the performance of PEM and Liquid Biopsy in visualizing and characterizing breast abnormalities

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Liquid Biopsy
• Positron Emission Mammography (PEM)

Trial Overview The study aims to see if results from the Liquid Biopsy, which detects early tumors through blood analysis, match up with images from PEM. PEM uses a special camera and injected isotopes to find tumors in the breast.

How Is the Trial Designed?

Group I: Liquid Biopsy and Positron Emission Mammography (PEM) Experimental Treatment 2 Interventions

To perform the Liquid Biopsy assays, a baseline blood sample will be collected prior to the MRI-guided biopsy, and a follow-up blood and a tissue sample (if available) may be requested post-surgery If malignancy is confirmed by the standard of care histopathology results. To perform the Positron Emission Mammography (PEM), participants will be injected with 74 megabecquerel (MBq) of commercially distributed 2-\[fluorine-18\]-fluoro-2-deoxy-D-glucose (F-18 FDG). Following a delay of one hour for F-18 FDG uptake, the study participants will undergo a bilateral 4-view combination PEM scan.

Liquid Biopsy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Liquid Biopsy for:

• Monitoring and diagnosis of various cancers including breast cancer

Approved in European Union as Liquid Biopsy for:

• Non-invasive diagnosis and monitoring of cancer, including breast cancer

Approved in Canada as Liquid Biopsy for:

• Diagnosis and monitoring of cancer, including breast cancer

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Radialis Inc.

Industry Sponsor

Trials

1

Recruited

100+

The Princess Margaret Cancer Foundation

Collaborator

Trials

7

Recruited

1,300+

Published Research Related to This Trial

In a study of 254 metastatic breast cancer patients, the EPISPOT assay detected viable circulating tumor cells (CTC) in 59% of cases, indicating a significant presence of these cells in the bloodstream.

The presence of viable CTC, as measured by both the EPISPOT and CellSearch assays, was linked to overall survival, with the combination of both methods providing the strongest prediction of patient outcomes, highlighting their prognostic relevance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic relevance of viable circulating tumor cells detected by EPISPOT in metastatic breast cancer patients. Ramirez, JM., Fehm, T., Orsini, M., et al.[2022]

Circulating Tumor Cells (CTCs) are crucial for understanding breast cancer metastasis, as they can migrate to vital organs like the lungs and brain even in early stages, highlighting the aggressive nature of this cancer.

Liquid biopsy, which isolates CTCs from blood samples, offers a non-invasive and potentially earlier detection method for breast cancer compared to traditional tissue biopsies, making it a promising tool for improving diagnosis and treatment monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection Methods and Clinical Applications of Circulating Tumor Cells in Breast Cancer. Zhang, H., Lin, X., Huang, Y., et al.[2021]

Circulating tumor cells (CTCs) are emerging as important liquid-based biomarkers in oncology, particularly for breast cancer, offering a new way to monitor treatment response and patient outcomes.

The review highlights the use of the FDA-approved CellSearch platform for CTC enumeration, emphasizing its potential in assessing radiation treatment response and ongoing clinical studies exploring its predictive capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Circulating Tumor Cells in Breast Cancer and Implications for Radiation Treatment Decisions. Goodman, CR., Speers, CW.[2021]

Circulating tumor cells (CTCs) in blood can be effectively monitored through a simple blood withdrawal procedure, providing a non-invasive method for tracking cancer progression and treatment response in patients with various cancers, including breast, colorectal, prostate, and lung cancer.

The study highlights the clinical utility of CTC testing in different treatment phases (neoadjuvant, adjuvant, and palliative), supporting its role in predicting treatment efficacy and enhancing monitoring of malignant diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Circulating tumor cells: what we know, what do we want to know about them and are they ready to be used in clinics? Bielčiková, Z., Jakabová, A., Pinkas, M., et al.[2022]

A study involving 92 breast cancer patients demonstrated that RT-qPCR can effectively detect specific gene expressions in circulating tumor cells (CTCs) at the single-cell level, highlighting its sensitivity and specificity for molecular characterization.

The results showed significant heterogeneity in gene expression among patients, with CTCs from operable and metastatic breast cancer patients expressing various genes, suggesting that RT-qPCR may provide more positive results than the CellSearch system for detecting CTCs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gene expression profile of circulating tumor cells in breast cancer by RT-qPCR. Strati, A., Markou, A., Parisi, C., et al.[2022]

Liquid biopsy offers a non-invasive alternative to traditional tissue biopsy for early breast cancer detection, allowing for a more comprehensive analysis of tumor characteristics through the study of circulating tumor components like ctDNA, CTCs, and ctRNA.

This review highlights recent advancements in technologies and analytes used in liquid biopsies, emphasizing their potential to provide a complete molecular picture of breast cancer, which is crucial for effective monitoring and treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges and achievements of liquid biopsy technologies employed in early breast cancer. Alba-Bernal, A., Lavado-Valenzuela, R., Domínguez-Recio, ME., et al.[2023]

Circulating tumor cells (CTCs) can be captured and analyzed through liquid biopsies, providing a non-invasive alternative to traditional tissue biopsies for cancer diagnostics, particularly in breast, prostate, colon, and lung cancers.

Recent advancements in culturing viable CTCs from patients with advanced cancer have opened up new possibilities for functional studies, which can help identify metastatic cell properties and potential therapeutic targets for drug screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional Studies on Viable Circulating Tumor Cells. Pantel, K., Alix-Panabières, C.[2019]

Liquid biopsy offers a less invasive alternative to traditional tissue biopsy for monitoring breast cancer, utilizing circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs) found in the bloodstream.

This method allows for real-time tracking of tumor evolution and could improve disease management for postmenopausal women with breast cancer, addressing the limitations of invasive procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A headlight on liquid biopsies: a challenging tool for breast cancer management. Massihnia, D., Perez, A., Bazan, V., et al.[2017]

In a study of 190 patients, the Cellcollector method successfully detected circulating tumor cells (CTCs) in 74.8% of patients with metastatic breast cancer, while all patients with benign tumors tested negative for CTCs, demonstrating high specificity (100%) and moderate sensitivity (74.8%).

The study suggests that using Cellcollector for CTC detection not only aids in diagnosing metastatic breast cancer but also allows for further molecular testing, which could enhance clinical decision-making in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Circulating tumor cells in patients with breast tumors were detected by a novel device: a multicenter, clinical trial in China]. Li, JB., Geng, CZ., Yan, M., et al.[2018]

The study demonstrated that circulating tumor cells (CTCs) can be effectively captured from various breast cancer subtypes using EpCAM-based immunomagnetic enrichment followed by fluorescence-activated cell sorting (IE/FACS), although claudin-low subtypes showed significantly lower capture rates.

The method allows for the isolation of high-quality RNA from CTCs, which is suitable for RNA sequencing, enabling detailed gene expression analysis that can help in understanding the molecular characteristics of different breast cancer subtypes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EpCAM based capture detects and recovers circulating tumor cells from all subtypes of breast cancer except claudin-low. Ring, A., Mineyev, N., Zhu, W., et al.[2018]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2950195425000153

The impact of liquid biopsy in breast cancer This review comprehensively explores the role of LB in early detection, disease monitoring, treatment stratification, and resistance surveillance in BC.

2. nature.com nature.com/articles/s41392-024-02021-w

Liquid biopsy in cancer: current status, challenges and ... Compared with tissue biopsy, liquid biopsy has many advantages in the diagnosis and treatment of various types of cancer, including non-invasive ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11093063/

Circulating tumor cells et al.: towards a comprehensive liquid ... Over the course of the past decade, liquid biopsy has gained increased prominence in the management of patients with breast cancer (BC) (1).

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11010957/

The Role of Circulating Tumor Cells as a Liquid Biopsy for ... This review article explores the forefront of research and technology in the detection and isolation of circulating tumor cells (CTCs) for liquid biopsy ...

5. breast-cancer-research.biomedcentral.com breast-cancer-research.biomedcentral.com/articles/10.1186/s13058-025-02024-7

Advances in CTC and ctDNA detection techniques The Tempus xF liquid biopsy assay is a groundbreaking tool utilized in the detection of circulating ctDNA for breast cancer patients, providing ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12308030/

Liquid biopsy in breast cancer: Redefining precision ... This review aims to assess and summarize the utility of LB in BC patients. Firstly, we will provide a detailed description of circulating biomarkers such as ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2823252

Circulating Tumor DNA and Survival in Metastatic Breast ... Detection of ctDNA was associated with worse overall, progression-free, and disease-free survival in patients with metastatic breast cancer.