NCT05068726

Clinical Utility of FES F18 PET/CT in Metastatic Breast Cancer Patients

Terminated Last updated 31 July 2024

What this trial tests

trial testing 18F Fluoroestradiol Radiopharmaceutical with PET/CT in Metastatic Breast Cancer in 51 participants. Terminated before completion.

Timeline

5 January 2023

Primary endpoint
1 June 2024

1 June 2024

Quick facts

Lead sponsor	GE Healthcare
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	51
Start date	5 January 2023
Primary completion	1 June 2024
Estimated completion	1 June 2024
Sites	24 locations across United States

Drugs / interventions tested

• 18F Fluoroestradiol Radiopharmaceutical with PET/CT — full drug profile →

Conditions studied

• Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →

Sponsor

GE Healthcare — full company profile →

Who can join

Adults 18 to 99, female only, with Metastatic Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase 4, multi-center, open-label, prospective cohort study to evaluate the clinical utility of Fluoroestradiol F18 (Cerianna) PET/CT to guide therapeutic management in ER-positive, HER2-negative metastatic breast cancer patients with progressive disease on first-line standard-of-care hormonal therapy. All patients will undergo a Cerianna PET/CT scan. The treating physician will complete a standardized questionnaire to indicate the second-line therapeutic management plan before the scheduled Cerianna PET/CT. After interpretation of Cerianna PET/CT by local radiologist or nuclear medicine physician, the treating physician will fill out a similar questionnaire to specify the final therapeutic decision. The proportion of patients with a change in therapeutic management plan based on Cerianna PET/CT results will be the primary endpoint. During the study follow-up period of 18 months, data on standard-of-care imaging, treatments/procedures received, and clinical outcomes will be collected. Patients will be asked to complete a health-related quality of life questionnaire at their screening, 6-month, and 18-month visit. Secondary endpoints include visual and quantitative heterogeneity assessment of tumor Cerianna uptake, and PFS rates at 6 months and 18 months after Cerianna PET/CT, which will be assessed between patients with and without a change in therapeutic management plan. Maximum duration of follow-up for each patient: 20 months. First patient first visit to last patient last visit: estimated 36 months.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Current Approaches of Nuclear Molecular Imaging in Breast Cancer.
   Schäfer L, Altunay B, Heesch A, van Nijnatten T, et al · · 2025 · PMID 40647404 · DOI 10.3390/cancers17132105