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RECRUITING
NCT05659797
EARLY_PHASE1

FES BPET-DBT in Newly Diagnosed Breast Cancer

Sponsor: Abramson Cancer Center at Penn Medicine

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2023-10-02

Completion Date

2028-01

Last Updated

2026-02-27

Healthy Volunteers

No

Conditions

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

Locations (1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States