Actively Recruiting

Early Phase 1
Age: 18Years +
FEMALE
NCT05659797

FES BPET-DBT in Newly Diagnosed Breast Cancer

Led by Abramson Cancer Center at Penn Medicine · Updated on 2026-02-27

20

Participants Needed

1

Research Sites

221 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

FES BPET-DBT in Newly Diagnosed Breast Cancer

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants will be 18 years of age or older
  • Known estrogen receptor positive breast cancer confirmed by immunohistochemistry
  • At least one breast lesion 1.0 cm or larger seen on standard imaging such as mammogram, ultrasound, MRI, CT, or FDG-PET/CT
  • Willing to provide written informed consent and participate according to institutional and federal guidelines
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding females; urine pregnancy test required for women of child-bearing potential before PET imaging
  • Unable to tolerate imaging procedures as determined by an investigator or treating physician
  • Currently taking tamoxifen or raloxifene
  • Any current medical condition or illness that could compromise safety or study participation as assessed by a physician investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19130

Actively Recruiting

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Research Team

E

Erin o Schubert

CONTACT

H

Hannah Straughn

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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FES BPET-DBT in Newly Diagnosed Breast Cancer | DecenTrialz