FDG-PET/CT vs. CT for Monitoring Metastatic Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOdense University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Pregnant or lactating women
Ongoing oncological treatment for another cancer
Exclusively brain metastasis
Allergy to FDG
Trial design
Design model
Parallel
Treatments tested in this trial
FDG-PET/CT
Diagnostic testFDG-PET/CT is used regulary for a continuous, long term monitoring
CE-CT
Diagnostic testCE-CT is used regulary for a continuous, long-term monitoring
Treatment groups
420 Participants
are divided into 2 treatment groupsGroup A: FDG-PET/CTExperimental treatment 1 intervention
Group B: CTActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Overall survival
Time from randomization until death for any reason
Time frame
From date of randomization until the date of death assessed up to 54 months.Secondary outcomes
1
Quality of life: FACT-B
The average FACT-B score experienced by the patient
Time frame
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.2
Quality of Life: Patient complaints
Complaints related to the conduct of scans can be reported by the patients in an open question.
Time frame
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.3
Experience of progression
The number of progressions experienced by the patient
Time frame
The corresponding events will be continuously documented from randomization for up to 54 months.4
Start of a new treatment line due to progression
The number of start points of a new treatment line experienced by the patient
Time frame
The corresponding events will be continuously documented from randomization for up to 54 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov