RECRUITING

FES BPET-DBT in Newly Diagnosed Breast Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2023-10-02
Study Completion:2026-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05659797

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Participants will be ≥ 18 years of age.
  2. 2. Known ER positive (by immunohistochemistry) breast cancer.
  3. 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. 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.
  1. 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. 2. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.
  3. 3. Currently taking tamoxifen or raloxifene
  4. 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.

Contacts and Locations

Study Contact

Erin o Schubert
CONTACT
2155736569
erin.schubert@pennmedicine.upenn.edu
Hannah Straughn
CONTACT
hannah.straughn@pennmedicine.upenn.edu

Principal Investigator

Christine Edmonds, MD
PRINCIPAL_INVESTIGATOR
Abramson Cancer Center at Penn Medicine

Study Locations (Sites)

University of Pennsylvania
Philadelphia, Pennsylvania, 19130
United States

Collaborators and Investigators

Sponsor: Abramson Cancer Center at Penn Medicine

  • Christine Edmonds, MD, PRINCIPAL_INVESTIGATOR, Abramson Cancer Center at Penn Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-02
Study Completion Date2026-01

Study Record Updates

Study Start Date2023-10-02
Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

  • PET
  • 18F-Fluoroestradiol

Additional Relevant MeSH Terms

  • Breast Cancer