OncoMatch/Clinical Trials/NCT05659797
FES BPET-DBT in Newly Diagnosed Breast Cancer
Is NCT05659797 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments including BPET/DBT imaging and 18F-FES for breast cancer.
Treatment: BPET/DBT imaging · 18F-FES — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (positive by immunohistochemistry)
Known ER positive (by immunohistochemistry) breast cancer
Prior therapy
Cannot have received: selective estrogen receptor modulator (tamoxifen, raloxifene)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Pennsylvania · Philadelphia, Pennsylvania
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