Imaging for newly diagnosed breast cancer using a novel device
Pilot Study Evaluating the Uptake of [18F]Fluoroestradiol (FES) BPET/DBT in Primary Breast Cancer to Measure the Localized Extent of Estrogen Receptor Positive Disease
This study is testing a new imaging method for people with newly diagnosed estrogen-receptor positive breast cancer to see if it provides better information about their disease compared to standard imaging techniques.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Abramson Cancer Center at Penn Medicine Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05659797 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed ER-positive breast cancer and at least one breast lesion measuring 1.0 cm or greater.
Not a fit: Patients who are pregnant, breastfeeding, or currently taking tamoxifen or raloxifene may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accurate assessment of breast cancer extent, potentially leading to better treatment planning.
How similar studies have performed: While this approach is novel, similar imaging techniques have shown promise in other studies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Philadelphia, Pennsylvania
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.