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The SONImage Study
Sponsor: The Netherlands Cancer Institute
Summary
SONImage is a multicenter prospective imaging side study, in which a baseline FES-PET is added to conventional work up, in 100 patients with ER+ MBC who will receive endocrine treatment ± CDK 4/6 inhibition within the SONIA study (NCT03425838). SONImage will be executed in two Dutch centers: UMCG and Amsterdam UMC-location VUMC. The aim of the SONImage study is to (1) assess the relationship between FES/FDG-PET heterogeneity patterns at baseline and PFS for first-line endocrine treatment ± CDK 4/6 inhibition in ER+ MBC, and (2) to further improve that by developing a prediction model, within the SONIA study. This molecular imaging based multivariable prediction model may provide a unique measure of benefit of adding CDK 4/6 inhibition to first-line endocrine treatment, allowing patients and providers to weigh individual benefits and (long term) burden for optimized treatment decisions.
Official title: SONImage Study: Can Molecular Imaging Predict Outcome to First-line Endocrine Treatment ± CDK 4/6 Inhibition in Advanced ER+ Breast Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2019-12-05
Completion Date
2025-07
Last Updated
2025-04-18
Healthy Volunteers
No
Conditions
Interventions
FES-PET scan, and possibly one additional visit for an FDG-PET
One visit to either the UMCG or Amsterdam UMC-location VUMC is required for the FES-PET scan, and possibly one additional visit for an FDG-PET. A FES- or FDG-PET scan plus low dose CT will each induce an extra radiation burden of about 6.1 mSv (210 MBq injected for an average patient of 70 kilogram body weight).
Locations (2)
Netherlands Cancer Institute
Amsterdam, Netherlands
VU Medical Center
Amsterdam, Netherlands