Condition: Metastatic Breast Cancer · Response Monitoring · Sponsor: Odense University Hospital
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 overal…
This description comes directly from the study's public registry record.
Malene G Hildebrandt, MD, Professor · 0045 30171888 · malene.grubbe.hildebrandt@rsyd.dk
Helene V Pedersen, MSc · 0045 21647495 · helene.vasegaard.pedersen@rsyd.dk
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| Aalborg University Hospital | Aalborg, Denmark | Recruiting |
| Aarhus University Hospital | Aarhus, Denmark | Recruiting |
| Rigshospitalet | Copenhagen, Denmark | Recruiting |
| Esbjerg and Grindsted Hospital | Esbjerg, Denmark | Recruiting |
| Herlev and Gentofte Hospital | Herlev, Denmark | Recruiting |
| Odense University Hospital | Odense, Denmark | Recruiting |
| Hospital of Southern Jutland | Sønderborg, Denmark | Recruiting |
| Lille Baelt Hospital | Vejle, Denmark | Recruiting |
| Klinikum Der Technischen Universität München | München, Germany | Not Yet Recruiting |
| Irccs Azienda Ospedaliero - Universitario Di Bologna | Bologna, Italy | Recruiting |
| Humanitas Research Hospital | Milan, Italy | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT06877949