Comparing FDG-PET/CT and CT for Monitoring Metastatic Breast Cancer
FDG-PET/CT Versus Conventional CT for Response Monitoring in Metastatic Breast Cancer: A Multicenter Randomized Clinical Trial (MONITOR-RCT)
This study is testing if a special type of imaging called FDG-PET/CT can find problems in metastatic breast cancer patients sooner than regular CT scans, so they can start new treatments faster.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 420 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Odense University Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 11 sites (Aalborg and 10 other locations) |
| Trial ID | NCT06877949 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with biopsy-verified metastatic breast cancer who are eligible for first-line systemic treatment.
Not a fit: Patients with non-metastatic breast cancer or those not eligible for systemic treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates for patients with metastatic breast cancer by enabling earlier treatment interventions.
How similar studies have performed: Previous studies have suggested improved sensitivity of FDG-PET/CT over conventional imaging, but this approach is being rigorously tested in a prospective randomized setting for the first time.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aalborg and 10 other locations
- 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)
- Hospital of Southern Jutland — Sønderborg, Denmark (Recruiting)
- Lille Baelt Hospital — Vejle, Denmark (Recruiting)
- Klinikum Der Technischen Universität München — München, Germany (Not_yet_recruiting)
- Irccs Azienda Ospedaliero - Universitario Di Bologna — Bologna, Italy (Recruiting)
- Humanitas Research Hospital — Milan, Italy (Not_yet_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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.