FDG-PET/CT vs. CT for Monitoring Metastatic Breast Cancer
Launched by ODENSE UNIVERSITY HOSPITAL · Mar 10, 2025
Trial Information
Current as of April 26, 2025
Recruiting
Keywords
ClinConnect Summary
The MONITOR-RCT clinical trial is studying whether a special imaging technique called FDG-PET/CT can help doctors better monitor patients with metastatic breast cancer compared to the standard CT scans. This trial hopes to find out if using FDG-PET/CT can detect disease progression earlier, allowing for quicker treatment decisions that might improve survival and quality of life for patients. The study will include 420 participants who have recently been diagnosed with metastatic breast cancer and are eligible for first-line treatment.
To participate, individuals must be at least 18 years old and have a confirmed diagnosis of metastatic breast cancer. They will undergo FDG-PET/CT scans at scheduled times during the study, along with receiving standard treatment. Participants will also be asked to fill out questionnaires about their quality of life throughout the trial. The goal is to see if FDG-PET/CT can lead to better outcomes compared to traditional CT scans, potentially reducing the need for extra tests and hospital visits.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Women and men aged ≥18 years
- • 2. 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.
- • 3. Considered eligible for first-line systemic treatment
- • 4. Considered eligible for continuous treatment monitoring by scans.
- • 5. Signed informed consent
- • 6. 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
- Exclusion Criteria:
- • 1. Pregnant or lactating women
- • 2. Ongoing oncological treatment for another cancer
- • 3. Exclusively brain metastasis
- • 4. Allergy to FDG
About Odense University Hospital
Odense University Hospital is a leading academic medical center located in Denmark, dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital is committed to enhancing patient outcomes and fostering collaboration among multidisciplinary teams. With a focus on translating scientific discoveries into practical applications, Odense University Hospital leverages its state-of-the-art facilities and expertise to conduct rigorous trials across various medical fields, ensuring adherence to the highest ethical and regulatory standards. Through these efforts, the hospital aims to contribute significantly to the global body of medical knowledge and improve the quality of care for patients both locally and internationally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Copenhagen, , Denmark
Odense, , Denmark
Aalborg, , Denmark
Aarhus, , Denmark
Herlev, , Denmark
Milan, , Italy
Esbjerg, , Denmark
Sønderborg, , Denmark
Vejle, , Denmark
München, , Germany
Bologna, , Italy
Patients applied
Trial Officials
Malene G Hildebrandt, MD, Professor
Principal Investigator
Odense University Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported