NCT04125277

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 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Dec 2019

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 14, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

December 5, 2019

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

April 18, 2025

Status Verified

April 1, 2025

Enrollment Period

5.6 years

First QC Date

October 10, 2019

Last Update Submit

April 15, 2025

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival after first line treatment (PFS1)

    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.

    5 years

Secondary Outcomes (3)

  • Patient response

    5 years

  • Response measurement individual lesion

    5 years

  • Response measurement target lesions

    5 years

Other Outcomes (1)

  • Association baseline FES/FDG-PET heterogeneity score with primary endpoint.

    5 years

Study Arms (1)

Imaging

EXPERIMENTAL

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).

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

Interventions

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

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).

Imaging

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Contra-indication for PET imaging.
  • Use of estrogen receptor ligands (i.e. tamoxifen or fulvestrant) ≤ 5 weeks before FES-PET imaging.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Netherlands Cancer Institute

Amsterdam, Netherlands

Location

VU Medical Center

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • C. P. Schröder, MD, PhD

    The Netherlands Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2019

First Posted

October 14, 2019

Study Start

December 5, 2019

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

April 18, 2025

Record last verified: 2025-04

Locations

NL(2)