Comparing FDG-PET/CT and CT for Monitoring Metastatic Breast Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of FDG-PET/CT compared to conventional CT for monitoring patients with metastatic breast cancer. The goal is to determine if FDG-PET/CT can detect disease progression earlier, allowing for timely initiation of second-line therapies. The study involves a randomized, parallel group design where participants will receive either FDG-PET/CT or standard CT monitoring. The findings aim to provide robust evidence on the potential survival benefits of using FDG-PET/CT in this patient population.

Why it matters

Who can join: the full rules

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

Where it's running

• Aalborg University Hospital
  Aalborg, Denmark Recruiting
• Aarhus University Hospital
  Aarhus, Denmark Recruiting
• Rigshospitalet
  Copenhagen, Denmark Recruiting
• Esbjerg and Grindsted Hospital
  Esbjerg, Denmark Recruiting
• Herlev and Gentofte Hospital
  Herlev, Denmark Recruiting
• Odense University Hospital
  Odense, Denmark Recruiting

Study contacts

• Principal investigator: Malene G Hildebrandt, MD, Professor — Odense University Hospital
• Study coordinator: Malene G Hildebrandt, MD, Professor
• Email: malene.grubbe.hildebrandt@rsyd.dk
• Phone: 0045 30171888

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.