Status:
ACTIVE_NOT_RECRUITING
The SONImage Study
Lead Sponsor:
The Netherlands Cancer Institute
Collaborating Sponsors:
Dutch Cancer Society
BOOG Study Center
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 inhi...
Detailed Description
Estrogen receptor positive (ER+) breast cancer is the most common cancer and the most frequent cause of cancer-related death in women in the Western World. Cyclin-dependent kinase 4 and 6 (CDK 4/6) in...
Eligibility Criteria
Inclusion
- Patient is eligible and participates in the SONIA trial for ER+ MBC.
- Able to give written informed consent and to comply with the SONImage protocol.
- Documentation of histologically confirmed diagnosis of estrogen receptor (ER) expression \>10% breast cancer based on local results. The receptor status can be determined on the primary tumor or on a tumor biopsy of a metastatic lesion.
Exclusion
- A patient who meets the exclusion criteria of the SONIA trial (see SONIA protocol).
- Contra-indication for PET imaging.
- Use of estrogen receptor ligands (i.e. tamoxifen or fulvestrant) ≤ 5 weeks before FES-PET imaging.
Key Trial Info
Start Date :
December 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04125277
Start Date
December 5 2019
End Date
July 1 2025
Last Update
April 18 2025
Active Locations (2)
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1
Netherlands Cancer Institute
Amsterdam, Netherlands
2
VU Medical Center
Amsterdam, Netherlands