Status:
RECRUITING
FDG-PET/CT vs. CT for Monitoring Metastatic Breast Cancer
Lead Sponsor:
Odense University Hospital
Conditions:
Metastatic Breast Cancer
Response Monitoring
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Background Breast cancer is the most commonly diagnosed cancer in Europe and worldwide. With a continuously increasing incidence, it is estimated that by 2040, the breast cancer burden will increase t...
Eligibility Criteria
Inclusion
- Women and men aged ≥18 years
- 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.
- Considered eligible for first-line systemic treatment
- Considered eligible for continuous treatment monitoring by scans.
- Signed informed consent
- 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
- Pregnant or lactating women
- Ongoing oncological treatment for another cancer
- Exclusively brain metastasis
- Allergy to FDG
Key Trial Info
Start Date :
April 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT06877949
Start Date
April 2 2025
End Date
April 1 2029
Last Update
December 31 2025
Active Locations (11)
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1
Aalborg University Hospital
Aalborg, Denmark, 9000
2
Aarhus University Hospital
Aarhus, Denmark, 8200
3
Rigshospitalet
Copenhagen, Denmark, 2100
4
Esbjerg and Grindsted Hospital
Esbjerg, Denmark, 6700