FDG-PET/CT vs. CT for Monitoring Metastatic Breast Cancer
MONITOR-RCT
FDG-PET/CT Versus Conventional CT for Response Monitoring in Metastatic Breast Cancer: A Multicenter Randomized Clinical Trial (MONITOR-RCT)
2 other identifiers
interventional
420
3 countries
11
Brief Summary
Several studies have shown improved sensitivity of FDG-PET/CT compared with conventional imaging for diagnosing metastatic breast cancer in retrospective and smaller prospective studies. For response monitoring, we expect FDG-PET/CT to detect disease progression earlier than CT in patients treated for metastatic breast cancer, enabling earlier start of second-line therapies. Current knowledge about the potential benefit of FDG-PET/CT for response monitoring of patients with metastatic breast cancer comes from observational studies. Consequently, current evidence is only hypothesis-generating and prospective, randomized trials such as the MONITOR-RCT are needed to corroborate these findings. The MONITOR-RCT clinical trial aims to investigate whether monitoring with FDG-PET/CT can improve survival in patients diagnosed with metastatic breast cancer. It is a parallel group comparative randomized trial comparing an experimental monitoring strategy based on FDG-PET/CT with a standard monitoring strategy based on CT. Participating patients should have newly diagnosed metastatic breast cancer and be considered eligible for initiating first-line medical treatment and subsequent regular response monitoring. A total of 420 patients will be included in the study, with recruitment taking place across 11 participating hospital sites in Denmark, Germany, and Italy. The main questions it aims to answer are:
- Can monitoring with FDG-PET/CT compared to conventional CT prolong the overall survival of MBC patients?
- Is this-as expected-due to earlier detection of disease progression and earlier initiation of second-line therapies?
- Is this accompanied by less need for additional diagnostics, less need for hospitalization, and improved quality of life? Participants will:
- Undergo FDG-PET/CT scans at scheduled intervals to monitor disease progression.
- Be given standard treatments as part of oncological care, which is informed by the FDG-PET/CT scans
- Fill out questionnaires about their quality of life at various time points throughout the study. Objectives are: Primary: To demonstrate superiority in overall survival of response monitoring with FDG-PET/CT in patients with metastatic breast cancer over response monitoring based on CT. Appropriately adapted PERCIST criteria for FDG-PET/CT and the RECIST1.1 criteria for CT will be used. Secondary: To demonstrate superiority in quality of life and exposure to oncologic treatment with FDG-PET/CT and to investigate the cost-effectiveness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2025
Longer than P75 for not_applicable
11 active sites
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
February 21, 2025
CompletedFirst Posted
Study publicly available on registry
March 14, 2025
CompletedStudy Start
First participant enrolled
April 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2029
February 20, 2026
December 1, 2025
4 years
February 21, 2025
February 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
Time from randomization until death for any reason
From date of randomization until the date of death assessed up to 54 months.
Secondary Outcomes (10)
Quality of life: FACT-B
Measured at baseline, after 3, 6, 9, 12, 18, 24, 30, 36, 42, 48 and 54 months - if the patient is still alive. Average over all time points wil be reported.
Quality of Life: Patient complaints
Assessed at baseline, after 3, 6, 9, 12, 18, 24, 30, 36, 42, 48 and 54 months - if the patient is still alive. Reporting will not be time point specific.
Experience of progression
The corresponding events will be continuously documented from randomization for up to 54 months.
Start of a new treatment line due to progression
The corresponding events will be continuously documented from randomization for up to 54 months.
Time to first progression
From date of randomization until the date of first documented progression assessed up to 54 months.
- +5 more secondary outcomes
Study Arms (2)
FDG-PET/CT
EXPERIMENTALMonitoring of patients with FDG-PET/CT
CT
ACTIVE COMPARATORMonitoring of patients with current standard.
Interventions
FDG-PET/CT is used regulary for a continuous, long term monitoring
Eligibility Criteria
You may qualify if:
- Women and men aged ≥18 years
- Diagnosis of distant relapsed MBC (biopsy-verified) or de novo breast cancer. In patients with distant relapsed MBC, biopsy verification from a distant metastasis is required. In patients with de novo MBC, biopsy verification of primary tumor and diagnostic imaging with distant metastasis with a typical pattern of MBC is required.
- Considered eligible for first-line systemic treatment
- Considered eligible for continuous treatment monitoring by scans.
- Signed informed consent
- Participants must have the ability to read and understand the following languages based on their country of participation: in Denmark, patients must be able to read and understand Danish; in Italy, they must be able to read and understand Italian or English; and in Germany, they must be able to read and understand German or English.
- In case of patients for whom it is necessary to start first-line systemic treatment while still waiting for the evaluation of the biopsy, it is allowed to include the patients, as long as the other criteria are fulfilled and the biopsy is made or planned. In case verification by biopsy fails, the patients will leave the trial (cf. 4c). We expect that up to 3% of the patients included will start first-line systemic treatment prior to evaluation of the biopsy
You may not qualify if:
- Pregnant or lactating women
- Ongoing oncological treatment for another cancer
- Exclusively brain metastasis
- Allergy to FDG
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Aalborg University Hospital
Aalborg, 9000, Denmark
Aarhus University Hospital
Aarhus, 8200, Denmark
Rigshospitalet
Copenhagen, 2100, Denmark
Esbjerg and Grindsted Hospital
Esbjerg, 6700, Denmark
Herlev and Gentofte Hospital
Herlev, 2730, Denmark
Odense University Hospital
Odense, 5000, Denmark
Hospital of Southern Jutland
Sønderborg, 6400, Denmark
Lille Baelt Hospital
Vejle, 7100, Denmark
Klinikum Der Technischen Universität München
München, 81675, Germany
Irccs Azienda Ospedaliero - Universitario Di Bologna
Bologna, 40138, Italy
Humanitas Research Hospital
Milan, 20089, Italy
Related Publications (2)
Naghavi-Behzad M, Vogsen M, Vester RM, Olsen MMB, Oltmann H, Braad PE, Asmussen JT, Gerke O, Vach W, Kidholm K, Kodahl AR, Weber W, Hildebrandt MG. Response monitoring in metastatic breast cancer: a comparison of survival times between FDG-PET/CT and CE-CT. Br J Cancer. 2022 May;126(9):1271-1279. doi: 10.1038/s41416-021-01654-w. Epub 2022 Jan 10.
PMID: 35013575BACKGROUNDVogsen M, Harbo F, Jakobsen NM, Nissen HJ, Dahlsgaard-Wallenius SE, Gerke O, Jensen JD, Asmussen JT, Jylling AMB, Braad PE, Vach W, Ewertz M, Hildebrandt MG. Response Monitoring in Metastatic Breast Cancer: A Prospective Study Comparing 18F-FDG PET/CT with Conventional CT. J Nucl Med. 2023 Mar;64(3):355-361. doi: 10.2967/jnumed.121.263358. Epub 2022 Oct 7.
PMID: 36207136BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Malene G Hildebrandt, MD, Professor
Odense University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2025
First Posted
March 14, 2025
Study Start
April 2, 2025
Primary Completion (Estimated)
April 1, 2029
Study Completion (Estimated)
April 1, 2029
Last Updated
February 20, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- The possibility to apply for IPD data access will be opened after end of the study.
- Access Criteria
- Cr. the plan description given above.
While most of the data itself will not be publicly accessible due to its sensitive nature metadata will be made openly accessible in well-known open repositories under controlled access where applicable. Detailed information about data access conditions will be included, specifying that data is available only under strict ethical and legal guidelines, with access requests subject to approval by ethics committees and data-use agreements as mandated by GDPR and national regulations.