Clinical trial · Interventional
Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone
Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone: A Whole Body MRI Study MILANO : RESPECT-MI
NCT06321666CI-TRIAL-00075248RESPECT-MIunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 is a non randomized, single arm study, where each patient will undergo imaging with Computed Tomography (CT) and Whole-body magnetic resonance imaging (WB-MRI) at different timepoint. The primary endpoint is time to progression as documented by CT or WB-MRI.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| WB-MRI | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- WB-MRI and CT Scan
- description
- CT scan (neck/thorax/abdomen/pelvis) and WB-MRI
- interventionNames
- Other: WB-MRI
Primary outcomes (1)
- measure
- Proportion of disease progression in bone metastasis identified by WB-MRI prior to CT scan
- timeFrame
- 36 months
- description
- Number of patients where disease progression in bone metastases were identified using WB-MRI prior to identification by CT scan
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological diagnosis of breast cancer * Single or multiple bone metastases (additional 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 Exclusion Criteria: * Radical treatment to sole site of metastatic disease e.g. Cyberknife to solitary bone metastasis * Absolute contraindication to MRI studies, CT scans, bone scans or FDG-PET/CT * Pregnancy * Psychological, familial, sociological or geographical conditions that would hamper compliance with the study protocol; such conditions should be discussed with the patient as part of the informed consent process.
References
Publications (0)
Data not yet available
No reference posted for this study.