FES BPET-DBT in Newly Diagnosed Breast Cancer

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Device: BPET/DBT imaging; Drug: 18F-FES

Detailed Description

The FES-BPET/DBT imaging session will include an injection of approximately 6 mCi (expected range of injected dose is 3-7 mCi) FES. Pilot data will be collected to evaluate image quality of FES-BPET/DBT in primary breast cancer. Size and focality of breast cancer extent as measured by FES-BPET/DBT will be compared to disease extent on standard breast imaging modalities. FES uptake on BPET/DBT, as measured by SUV, will be compared to ER expression by immunohistochemistry (IHC) on biopsy specimens. In addition, all subjects in this study will be recruited to the open ended Penn protocol titled 'Evaluation of Long-Axial Field-of-View Positron Emission Tomography Scanner,' IRB #843546. In those subjects who consent to this proposed study as well as #843546, assessment of disease extent on FES-BPET/DBT will be compared to that on whole body PET. Of note, those subjects who also consent to #843546 will not undergo any additional injected dose of FES radiotracer. This preliminary study seeks to evaluate FES-BPET/DBT as a preoperative imaging assay of ER-positive breast cancer disease extent within the breast.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Erin o Schubert; Phone Number: 2155736569; Email: erin.schubert@pennmedicine.upenn.edu
• Study Contact Backup: Name: Hannah Straughn; Email: hannah.straughn@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19130
      • Recruiting
      • University of Pennsylvania
      • Contact: Erin Schubert; Phone Number: 215-753-6569; Email: erin.schubert@pennmedicine.upenn.edu
      • Contact: Hannah Straughn; Email: hannah.straughn@pennmedicine.upenn.edu
      • Principal Investigator: Christine Edmonds, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FES BPET-DBT; FES-BPET/DBT imaging session	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; Other Names: 18F-fluoroestradiol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uptake of FES on BPET	Different types of SUV measurements (e.g. Max, Mean and Peak) may be tested to identify the optimal method for analyses for future studies of FES-BPET/DBT.	6 weeks
Image quality	The image quality of the study DBT will be compared to the clinical DBT in terms of image quality	6 weeks
Image artifacts	Image artifacts on study DBT will be compared to clinical DBT	6 weeks
Parenchymal appearance	The parenchymal appearance of the study DBT will be compared to the clinical DBT	6 weeks
Tumor size and extent	The size/extent of tumor on the study DBT will be compared to the clinical DBT	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estrogen receptor IHC	Clinical immunohistochemical estrogen receptor (ER) results from biopsy or surgery will be compared to FES PET uptake	8 weeks

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Investigators: Principal Investigator: Christine Edmonds, MD, Abramson Cancer Center at Penn Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 12, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: PET; 18F-Fluoroestradiol
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; 16-fluoroestradiol
• Other Study ID Numbers: UPCC 08122 (Abramson Cancer center); 852000 (Other Identifier: Abramson Cancer center)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes