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Search / Trial NCT06877949

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

Metastatic Breast Cancer Response Monitoring Fdg Pet/Ct Survival Progression

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.

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

0 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