NCT05659797

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1 breast-cancer

Timeline
20mo left

Started Oct 2023

Typical duration for early_phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Oct 2023Jan 2028

First Submitted

Initial submission to the registry

December 5, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

October 2, 2023

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

4.3 years

First QC Date

December 5, 2022

Last Update Submit

February 26, 2026

Conditions

Breast Cancer

Keywords

PET18F-Fluoroestradiol

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (1)

  • Estrogen receptor IHC

    8 weeks

Study Arms (1)

FES BPET-DBT

EXPERIMENTAL

FES-BPET/DBT imaging session

Device: BPET/DBT imagingDrug: 18F-FES

Interventions

18F-FESDRUG

Radiolabelled fluoroestradiol for PET imaging

Also known as: 18F-fluoroestradiol
FES BPET-DBT
BPET/DBT imagingDEVICE

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).

FES BPET-DBT

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants will be ≥ 18 years of age.
  • Known ER positive (by immunohistochemistry) breast cancer.
  • 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.
  • 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.

You may not qualify if:

  • 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..
  • Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.
  • Currently taking tamoxifen or raloxifene
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19130, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

16-fluoroestradiol

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Christine Edmonds, MD

    Abramson Cancer Center at Penn Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin o Schubert

CONTACT

2155736569erin.schubert@pennmedicine.upenn.edu

Hannah Straughn

CONTACT

hannah.straughn@pennmedicine.upenn.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2022

First Posted

December 21, 2022

Study Start

October 2, 2023

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations

US(1)