FDG-PET/CT versus conventional CT for response monitoring in metastatic breast cancer: A pilot study for a randomized clinical trial (MONITOR-PILOT)
Key facts
- Where
- Esbjerg, Odense C és Vejle, DániaSee the 3 sites
- Phase
- 2/3. fázis
Where in Dánia
- Esbjerg SygehusEsbjerg, DániaNo longer taking part
- Odense University HospitalOdense C, DániaNo longer taking part
- Lillebaelt HospitalVejle, DániaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Odense University Hospital
- Trial code
- EU 2023-506550-20-00
- Record updated
- 2025. június 13.
- Original description
The primary objective of the MONITOR-RCT is to demonstrate that in patients with metastatic breast cancer, response monitoring based on FDG-PET/CT is superior to response monitoring based on CT with respect to overall survival. The objective will be based on applying standardized response evaluation criteria, using an appropriate adaptation of the PERCIST criteria for FDG-PET/CT and the RECIST1.1 criteria for CT.Read full original descriptionShow less
The primary objective of the MONITOR-RCT is to demonstrate that in patients with metastatic breast cancer, response monitoring based on FDG-PET/CT is superior to response monitoring based on CT with respect to overall survival. The objective will be based on applying standardized response evaluation criteria, using an appropriate adaptation of the PERCIST criteria for FDG-PET/CT and the RECIST1.1 criteria for CT.
Inclusion: Women and men aged≥18 years; Diagnosis of distant relapsed MBC (biopsy-verified) or de novo breast cancer (biopsy verification of primary tumor and disseminated disease at baseline scan); Considered eligible for first-line systemic treatment; Considered eligible for continuous treatment monitoring by scans; Signed informed consent; Ability to read and understand Danish language.
Exclusion: Ongoing oncological treatment for another cancer; Allergy to FDG; Pregnant or lactating women; Exclusively brain metastasis.