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FDG-PET/CT vs. CT for Monitoring Metastatic Breast Cancer

RecruitingNAAges 18 Years - anyAllOdense University Hospital
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In plain words

What the trial is, and whether it could suit you

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 ran

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📋 Eligibility rules (as published)
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
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What it tests

  • FDG-PET/CT
  • CE-CT
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Where

11 sites
Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
Esbjerg and Grindsted Hospital
Esbjerg, Denmark
Herlev and Gentofte Hospital
Herlev, Denmark
Odense University Hospital
Odense, Denmark
Hospital of Southern Jutland
Sønderborg, Denmark
Lille Baelt Hospital
Vejle, Denmark

…and 3 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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