2023-506550-20-00CompletedPhase 2/3
FDG-PET/CT versus conventional CT for response monitoring in metastatic breast cancer: A pilot study for a randomized clinical trial (MONITOR-PILOT)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 13 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 8 Dec 2023
- Start date
- 5 Jul 2024
- Lead sponsor
- Odense University Hospital
- Diseases
- Metastatic breast cancer
- EU CT number
- 2023-506550-20-00
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 30
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- Ongoing oncological treatment for another cancer
- Allergy to FDG
Other
- Pregnant or lactating women
- Exclusively brain metastasis
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Esbjerg Sygehus | Esbjerg | Denmark | Completed |
| Odense University Hospital | Odense C | Denmark | Completed |
| Lillebaelt Hospital | Vejle | Denmark | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.