Recruiting

FES BPET-DBT in Newly Diagnosed Breast Cancer

ClinicalTrials.gov IDNCT05659797

PhaseEARLY_PHASE1

Enrollment20

SponsorAbramson Cancer Center at Penn Medicine

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Breast Cancer

About this study

Patients with newly diagnosed primary estrogen-receptor (ER) positive breast cancer, with at least one breast lesion that is 1.0 cm in diameter or greater, may be eligible for this study. Patients may participate in this study if they are at least 18 years of age. Up to 20 evaluable subjects will participate in a single imaging cohort. Study subjects will undergo imaging of the breast with a novel device combining dedicated Breast Positron Emission Tomography (BPET) and Digital Breast Tomosynthesis (DBT) following intravenous injection of \[18F\]-Fluoroestradiol (FES). This is an observational study; FES-BPET/DBT will not be used to direct treatment decisions. While patients and referring physicians will not be blinded to the FES-BPET/DBT results, treatment decisions are made by the treating physicians based upon standard clinical imaging.

Interventions

Device: BPET/DBT imaging — Imaging of the breast with a novel device combining dedicated Breast Positron Emission Tomography (BPET) and Digital Breast Tomosynthesis (DBT) following intravenous injection of \[18F\]-Fluoroestradiol (FES).
Drug: 18F-FES — Radiolabelled fluoroestradiol for PET imaging

Primary outcomes

Uptake of FES on BPET (6 weeks)
Image quality (6 weeks)
Image artifacts (6 weeks)
Parenchymal appearance (6 weeks)
Tumor size and extent (6 weeks)

Eligibility information

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.

Study locations

University of Pennsylvania, Philadelphia, Pennsylvania 19130 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.