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Cancer Diagnostic

Liquid Biopsy and Positron Emission Mammography (PEM) for Breast Cancer

N/A

Recruiting

Led By Vivianne Freitas, MD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Individuals who are older than 18 years of age

Individuals who are planned to undergo an MRI-guided biopsy based on high-risk screening imaging detected lesions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

"This trial aims to compare two tests, Liquid Biopsy and Positron Emission Mammography (PEM), in women at high risk of breast cancer. Liquid Biopsy is a blood test

Who is the study for?

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).Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include discomfort or bruising at the injection site for PEM, allergic reactions to the injected isotope, and typical risks associated with blood draws like pain or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am older than 18 years.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Correlation of paired samples between Liquid Biopsy data and Positron Emission Mammography (PEM) images

Trial Design

1Treatment groups

Experimental Treatment

Group I: Liquid Biopsy and Positron Emission Mammography (PEM)Experimental Treatment2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Mammography (PEM)

2010

N/A

~40

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,476 Previous Clinical Trials

485,150 Total Patients Enrolled

53 Trials studying Breast Cancer

29,524 Patients Enrolled for Breast Cancer

Vivianne Freitas, MDPrincipal InvestigatorUniversity Health Network, Toronto

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the collective count of individuals actively involved in this research trial?

"Indeed, the details on clinicaltrials.gov highlight that this investigation is actively seeking participants. The trial was initially disclosed on September 21st, 2023, and most recently revised on February 12th, 2024. It aims to enroll a total of 30 patients across one designated site."

Answered by AI

Is the registration process currently ongoing for this clinical trial?

"Indeed, the details outlined on clinicaltrials.gov indicate that this investigation is actively seeking candidates. The trial's initial posting was documented on September 21st, 2023, with the most recent revision noted on February 12th, 2024. Recruitment aims to secure enrollment of 30 individuals from a single designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Positron Emission Mammography and Liquid Biopsy in Women With High-risk Breast Screenings

2023. "Positron Emission Mammography and Liquid Biopsy in Women With High-risk Breast Screenings". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06268405.