FES BPET-DBT in Newly Diagnosed Breast Cancer

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT05659797
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BPET/DBT imaging — DEVICE
    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).
  • 18F-FES — DRUG
    Radiolabelled fluoroestradiol for PET imaging

Study Details

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.

Key Dates

Start date
Oct 2, 2023
Status verified
Feb 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: FES BPET-DBT
    FES-BPET/DBT imaging session

Primary Outcome Measure

Uptake of FES on BPET [ Time Frame: 6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19130
Erin Schubert
[email protected]
215-753-6569
Hannah Straughn
[email protected]
Christine Edmonds, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Philadelphia, PA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Pennsylvania· Philadelphia, PA

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