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FES-PET/DBT Imaging for Breast Cancer

Phase < 1
Recruiting
Led By Christine Edmonds, MD
Research Sponsored by Abramson Cancer Center at Penn Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants will be ≥ 18 years of age.
Known ER positive (by immunohistochemistry) breast cancer.
Must not have
Currently taking tamoxifen or raloxifene
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will assess if a novel imaging device combining PET & DBT can aid in the diagnosis of breast cancer for those 18+. Up to 20 evaluable subjects will take part and receive FES-BPET/DBT imaging, but results won't direct treatment decisions.

Who is the study for?
This trial is for adults over 18 with newly diagnosed estrogen-receptor positive breast cancer, featuring at least one lesion that's 1.0 cm or larger. It's not suitable for pregnant or breastfeeding women, those unable to undergo imaging procedures, taking tamoxifen/raloxifene, or with conditions compromising safety/participation.
What is being tested?
The study tests a new imaging technique combining Breast Positron Emission Tomography (BPET) and Digital Breast Tomosynthesis (DBT) after an [18F]-Fluoroestradiol (FES) injection in patients. This observational study won't influence treatment decisions; up to 20 subjects will be imaged once.
What are the potential side effects?
Since this is an observational imaging study using BPET/DBT and FES injection, traditional medication side effects are not the focus. However, there may be risks associated with the imaging process itself or reactions to the FES tracer used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My breast cancer is estrogen receptor positive.
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I have a tumor larger than 1 cm visible on an imaging test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently taking tamoxifen or raloxifene.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Image artifacts
Image quality
Parenchymal appearance
+2 more
Secondary study objectives
Estrogen receptor IHC

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: FES BPET-DBTExperimental Treatment2 Interventions
FES-BPET/DBT imaging session

Find a Location

Who is running the clinical trial?

Abramson Cancer Center at Penn MedicineLead Sponsor
418 Previous Clinical Trials
464,102 Total Patients Enrolled
46 Trials studying Breast Cancer
360,867 Patients Enrolled for Breast Cancer
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
108,335 Total Patients Enrolled
40 Trials studying Breast Cancer
35,293 Patients Enrolled for Breast Cancer
Christine Edmonds, MDPrincipal InvestigatorAbramson Cancer Center at Penn Medicine

Media Library

FES BPET-DBT Clinical Trial Eligibility Overview. Trial Name: NCT05659797 — Phase < 1
Breast Cancer Research Study Groups: FES BPET-DBT
Breast Cancer Clinical Trial 2023: FES BPET-DBT Highlights & Side Effects. Trial Name: NCT05659797 — Phase < 1
FES BPET-DBT 2023 Treatment Timeline for Medical Study. Trial Name: NCT05659797 — Phase < 1
~0 spots leftby Jan 2025
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