Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The SONImage Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04125277
Recruitment Status : Recruiting
First Posted : October 14, 2019
Last Update Posted : January 12, 2022
Sponsor:
Collaborators:
Dutch Cancer Society
BOOG Study Center
Information provided by (Responsible Party):
C.P. Schroder, University Medical Center Groningen

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: FES-PET scan, and possibly one additional visit for an FDG-PET Not Applicable

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) inhibitors improve outcome, when added to standard first- and second-line endocrine therapy. However, they also add patient- and financial burden due to (long term) increased toxicity and hospital visits. Therefore, benefits of additional CDK 4/6 inhibitors should be weighed against their burden. Tools to support such treatment decisions by patients and providers are currently lacking. Whole body heterogeneity of ER expression, measured by 16α-[18F]fluoro-17β-estradiol (FES)-PET scan and 18F-fluorodeoxyglucose (FDG)-PET scan was related to time to progression on combined treatment in previous work. Therefore in SONImage a baseline FES-PET is added to conventional work up, in 100 patients with ER+ MBC who will receive first line endocrine treatment ± CDK 4/6 inhibition within the SONIA study. The objectives are 1. to correlate PFS1 (according to SONIA criteria) to baseline FES/FDG-PET heterogeneity; 2. to assess interaction between baseline FES/FDG-PET heterogeneity, treatment allocation, and PFS1 (according to SONIA criteria); 3. to correlate response measurements of individual lesions to baseline FES/FDG heterogeneity and detailed FES/FDG imaging features; 4. to develop a multivariable model to predict individual PFS benefit to first-line AI ± CDK 4/6 inhibition, based on detailed FES/FDG image features and standard clinicopathological information, in n=100 SONIA patients; 5. to validate this prediction model in two independent patient cohorts with baseline FES/FDG-PET scans (Dutch IMPACT-MBC trial; international ET-TRANSCAN trial). 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. Particularly for the approximately 25% of patients with ER+ MBC who have an excellent- or poor outcome despite CDK 4/6 inhibition in the first-line, this could have profound implications, as they may refrain from combined treatment. Ultimately, this could potentially contribute to FES/FDG-PET based treatment decisions in clinical practice, reduction of unnecessary toxicity and costs, while improving patient outcome and QoL.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: SONImage Study: Can Molecular Imaging Predict Outcome to First-line Endocrine Treatment ± CDK 4/6 Inhibition in Advanced ER+ Breast Cancer
Actual Study Start Date : December 5, 2019
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Imaging
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
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).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Patient response [ Time Frame: 5 years ]
    Per patient response according to RECIST1.1

  2. Response measurement individual lesion [ Time Frame: 5 years ]
    Change in size (=response measurement) per individual lesion at the largest measurable response measured on CT compared to baseline CT

  3. Response measurement target lesions [ Time Frame: 5 years ]
    - Per patient trajectory of change in size of target lesions according to RECIST 1.1, from baseline CT until CT at progression of disease.


Other Outcome Measures:
  1. Association baseline FES/FDG-PET heterogeneity score with primary endpoint. [ Time Frame: 5 years ]
    Cox-regression to estimate HRs for PFS and corresponding 95% CIs between FES/FDG heterogeneity groups, while adjusting for treatment allocation.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is eligible and participates in the SONIA trial for ER+ MBC.
  2. Able to give written informed consent and to comply with the SONImage protocol.
  3. 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 Criteria:

  1. A patient who meets the exclusion criteria of the SONIA trial (see SONIA protocol).
  2. Contra-indication for PET imaging.
  3. Use of estrogen receptor ligands (i.e. tamoxifen or fulvestrant) ≤ 5 weeks before FES-PET imaging.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04125277


Contacts
Layout table for location contacts
Contact: C. P. Schröder, MD, PhD +31 50 361 2821 c.p.schroder@umcg.nl
Contact: J. Boers, MD +31 50 361 6161 j.boers@umcg.nl

Locations
Layout table for location information
Netherlands
VU Medical Center Recruiting
Amsterdam, Netherlands
Contact: C. W. Menke-van der Houven van Oordt, MD, PhD    +31 20 444 4444    c.menke@amsterdamumc.nl   
Contact: R. Iqbal, MD    +31 20 444 4444    r.iqbal@amsterdamumc.nl   
Principal Investigator: C. W. Menke-van der Houven van Oordt, MD, PhD         
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9713 GZ
Contact: C. P. Schröder, MD, PhD    +31 50 361 2821    c.p.schroder@umcg.nl   
Contact: J. Boers, MD    +31 50 361 6161    j.boers@umcg.nl   
Principal Investigator: C. P. Schröder, MD, PhD         
Sponsors and Collaborators
University Medical Center Groningen
Dutch Cancer Society
BOOG Study Center
Investigators
Layout table for investigator information
Principal Investigator: C. P. Schröder, MD, PhD University Medical Center Groningen
Layout table for additonal information
Responsible Party: C.P. Schroder, Principal investigator, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT04125277    
Other Study ID Numbers: 201900572
First Posted: October 14, 2019    Key Record Dates
Last Update Posted: January 12, 2022
Last Verified: January 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases