Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone
- Conditions
- Metastatic Breast Cancer
- Interventions
- Other: WB-MRI
- Registration Number
- NCT06321666
- Lead Sponsor
- European Institute of Oncology
- Brief Summary
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.
- Detailed Description
This is a monocentric study. All patients will undergo assessments by CT and WB-MRI at all time points.
* A baseline bone scan or Fluorodeoxyglucose-Position Emission Tomography (FDG-PET) will be performed.
* CT scans and WB--MRI are performed every 12 weeks until week 96, and then every 24 weeks until disease progression is evident (as defined in section 7.1.3).
* At the point of disease progression, a repeat bone scan or FDG-PET/CT will be obtained in addition to the CT and WB-MRI. Participation in the trials ends at the point of disease progression.
Patients will be reviewed in outpatient clinic:
* At baseline
* Every 12 weeks until week 96, with the results of their recent scans.
* As with the imaging, the trial visits will change to every 24 weeks after the week 96 visit.
At the week 12 and week 36 visits, the patients will undergo a clinical examination and perform a pain thermometer score and Patient Imaging Questionnaire.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 58
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description WB-MRI and CT Scan WB-MRI CT scan (neck/thorax/abdomen/pelvis) and WB-MRI
- Primary Outcome Measures
Name Time Method Proportion of disease progression in bone metastasis identified by WB-MRI prior to CT scan 36 months Number of patients where disease progression in bone metastases were identified using WB-MRI prior to identification by CT scan
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
IEO Istituto Europeo di Oncologia
🇮🇹Milan, Italy