FES BPET-DBT in Newly Diagnosed Breast Cancer

Launched by ABRAMSON CANCER CENTER AT PENN MEDICINE · Dec 12, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new imaging technique for women who have recently been diagnosed with breast cancer that is positive for estrogen receptors (ER positive). To participate, patients must be at least 18 years old and have at least one breast lesion that is 1.0 cm or larger, which can be seen on standard imaging tests like a mammogram or ultrasound. The study will involve up to 20 women who will receive an intravenous injection of a special substance called \[18F\]-Fluoroestradiol (FES) before undergoing advanced imaging with a device that combines two types of breast imaging: Positron Emission Tomography (PET) and Digital Breast Tomosynthesis (DBT). This imaging will help researchers learn more about how the cancer behaves, but it will not influence treatment decisions, which will be based on traditional imaging results.

Eligible participants should not be pregnant or breastfeeding, and they should not be currently taking certain medications like tamoxifen or raloxifene. Before joining the study, women will need to give written consent, understanding that this is an investigational study. Throughout the trial, patients can expect to receive thorough explanations of the procedures and to be closely monitored for their safety. This study aims to enhance our understanding of breast cancer imaging and improve future treatments.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Participants will be ≥ 18 years of age.
• • 2. Known ER positive (by immunohistochemistry) breast cancer.
• • 3. 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.
• • 4. 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 Criteria:
• • 1. 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..
• • 2. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.
• • 3. Currently taking tamoxifen or raloxifene
• • 4. 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.

Trial Officials