RecruitingEarly Phase 1NCT05659797

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

Sponsor

Abramson Cancer Center at Penn Medicine

Enrollment

20 participants

Start Date

Oct 2, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses a special type of PET scan (a whole-body imaging tool) to look at how estrogen receptor-positive breast cancer behaves in the body after a new diagnosis. Researchers want to see if this scan provides useful information that standard imaging may miss. **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with estrogen receptor-positive (ER+) breast cancer - You have at least one tumor visible on standard imaging (mammogram, ultrasound, MRI, or CT scan) that is 1 cm or larger - You are willing to undergo the PET scan procedure **You may NOT be eligible if...** - You are pregnant or breastfeeding - You are currently taking tamoxifen or raloxifene - You have a medical condition that makes the scan unsafe or impractical Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBPET/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).

DRUG18F-FES

Radiolabelled fluoroestradiol for PET imaging

Locations(1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

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NCT05659797

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