Clinical trial · Interventional
Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone: A Whole Body MRI Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial is a feasibility study prior to a planned phase III trial. Currently, assessing response to treatment of metastatic breast cancer in the bone is limited by the technical problems associated with CT scans and bone scans. WB-MRI provides theoretical and practical advantages that allow for more detailed analysis of disease response or progression. This may allow for earlier identification of progressive disease and earlier change in treatment. Participants in the study will have a CT scan, bone scan and WB-MRI at baseline and then repeated CT and WB-MRI scans every 12 weeks (until week 96, and then every 24 weeks) until there is evidence of progressive disease on either of the imaging modalities. In addition to the regular scans on the study, patients will be given the opportunity to participate in a study of how reproducible the findings of WB-MRI scans are. At the point of disease progression, a repeat bone scan is performed and the involvement of the patient in the trial comes to an end.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bone scan | Diagnostic Test | — | UNRESOLVED |
| Computerised Tomography | Diagnostic Test | — | UNRESOLVED |
| Whole Body Magnetic Resonance Imaging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Main study group
- description
- Patients will have repeat CT (Computerised Tomography) scans and WB-MRI (Whole Body Magnetic Resonance Imaging) every 12 weeks until disease progression. A baseline bone scan (99mTc-MDP) will be performed. At the point of disease progression, a repeat bone scan will be obtained in addition to the CT and WB-MRI.
- interventionNames
- Diagnostic Test: Computerised Tomography
- Diagnostic Test: Whole Body Magnetic Resonance Imaging
- Diagnostic Test: Bone scan
- type
- OTHER
- label
- WB-MRI sub-study group
- description
- Patients will be given the opportunity to participate in a sub-study of WB-MRI reproducibility. This involves a repeat scan of the Whole Body Magnetic Resonance Imaging (WB-MRI) diffusion-weighted sequences. This will be shorter in duration than the full WB-MRI scan and will take place within one hour of completing the full WB-MRI scan.
- interventionNames
- Diagnostic Test: Whole Body Magnetic Resonance Imaging
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological diagnosis of breast cancer * Single or multiple bone metastases (no extraosseous or non-bony metastatic disease permitted) * Due to start a new line of either hormone therapy or chemotherapy (use of bisphosphonates / denosumab or targeted agents e.g. trastuzumab in addition to hormone therapy / chemotherapy permitted) * Aged 18 and over * Life expectancy of over 6 months * No current active malignancy other than breast cancer * Written informed consent must be given according to GCP, and national/local regulations Exclusion Criteria: * Radical treatment to sole site of metastatic disease e.g. Cyberknife to solitary bone metastasis * Absolute contraindication to MRI studies, CT scans or bone scans * Pregnancy * Psychological, familial, sociological or geographical conditions that would hamper compliance with the study protocol; such conditions should be discussed with the patient before registration in the trial before patient registration.
References
Publications (1)
- DERIVEDKosmin M, Padhani AR, Gogbashian A, Woolf D, Ah-See ML, Ostler P, Sutherland S, Miles D, Noble J, Koh DM, Marshall A, Dunn J, Makris A. Comparison of Whole-Body MRI, CT, and Bone Scintigraphy for Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to Bone. Radiology. 2020 Dec;297(3):622-629. doi: 10.1148/radiol.2020192683. Epub 2020 Oct 20. PMID 33078998