NCT04125277: SONImage

SONImage Study: Can Molecular Imaging Predict Outcome to First-line Endocrine Treatment ± CDK 4/6 Inhibition in Advanced ER+ Breast Cancer

Active, enrolled NA Last updated 15 April 2025

What this trial tests

NA trial testing FES-PET scan, and possibly one additional visit for an FDG-PET in Breast Cancer in 100 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

5 December 2019

Primary endpoint
1 July 2025

1 July 2025

Quick facts

Lead sponsor	The Netherlands Cancer Institute
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	100
Start date	5 December 2019
Primary completion	1 July 2025
Estimated completion	1 July 2025
Sites	2 locations across Netherlands

Drugs / interventions tested

• FES-PET scan, and possibly one additional visit for an FDG-PET

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

The Netherlands Cancer Institute

Who can join

18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Progression-free survival after first line treatment (PFS1)
  Time frame: 5 years
  Progression-free survival after first line treatment (PFS1) defined as time from randomization until objective disease progression, symptomatic deterioration, or initiation of a new therapeutic agent on first line treatment, death, or progression during a break in initial therapy and without further therapy within one month, whichever occurs first.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Application of PET Tracers in Molecular Imaging for Breast Cancer.
   Boers J, de Vries EFJ, Glaudemans AWJM, Hospers GAP, et al · · 2020 · cited 25× · PMID 32627087 · DOI 10.1007/s11912-020-00940-9
2. Current status of contemporary diagnostic radiotracers in the management of breast cancer: first steps toward theranostic applications.
   Altena R, Tzortzakakis A, Af Burén S, Tran TA, et al · · 2023 · cited 9× · PMID 37195374 · DOI 10.1186/s13550-023-00995-2