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

Inclusion Criteria4

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.

Exclusion Criteria4

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.

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