Imaging for newly diagnosed breast cancer using a novel device

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of a new imaging technique that combines Breast Positron Emission Tomography (BPET) and Digital Breast Tomosynthesis (DBT) in patients with newly diagnosed estrogen-receptor positive breast cancer. Participants will receive an injection of 18F-Fluoroestradiol (FES) and undergo imaging to assess the extent of their disease. The study aims to compare the imaging results with standard imaging modalities and evaluate the correlation between FES uptake and estrogen receptor expression. This is an observational study, meaning that the imaging results will not influence treatment decisions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participants will be ≥ 18 years of age.
2. Known ER positive (by immunohistochemistry) breast cancer.
3. At least one lesion ≥ 1.0 cm that is seen on standard imaging (e.g. mammogram, ultrasound, MRI, CT, FDG-PET/CT). Only one type of imaging is required to show a lesion.
4. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion Criteria:

1. Females who are pregnant or breast feeding will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential prior to PET imaging..
2. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.
3. Currently taking tamoxifen or raloxifene
4. Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study.

Where it's running

• University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Christine Edmonds, MD — Abramson Cancer Center at Penn Medicine
• Study coordinator: Erin o Schubert
• Email: erin.schubert@pennmedicine.upenn.edu
• Phone: 2155736569

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.