Metastatic Breast Cancer
Conditions
Brief summary
The objective of this study is to apply Whole-body DW imaging alongside the routine management of patients requiring systemic therapy for metastatic breast cancer to compare the time to progression of individual liver metastases within and between patients following stable disease or partial response to palliative systemic therapy for breast cancer.
Interventions
GENETICn/a - observational
Sponsors
Institute of Cancer Research, United Kingdom
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age over 18 years. * First metastatic breast cancer relapse after treatment for early stage disease * A minimum of 10 evaluable lesions in the liver on routine x-ray CT imaging * Patient prescribed cytotoxic, endocrine or biological therapies * Patient physically and psychologically fit enough to consider sequential WB-- - DWI imaging alongside their standard disease monitoring * Written informed consent
Exclusion criteria
* Diagnosis of other cancer within the last 5 years, other than resected non-melanoma skin cancer or cervical intraepithelial neoplasia * Diagnosis of brain metastases. * Contraindication to magnetic resonance MR imaging
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression rate of liver metastases | 3 months | Patients will be monitored by routine CT scans after 3 cycles of cytotoxic/biological therapy or after 3 months of endocrine therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression rate of skeletal metastases | 3 months | Patients will be monitored by routine CT scans after 3 cycles of cytotoxic/biological therapy or after 3 months of endocrine therapy |
| Global and local lesion Apparent Diffusion Coefficient (ADC) distributions of WB-DWI scans within individual patient | 3 months | Patients will be monitored by routine CT scans after 3 cycles of cytotoxic/biological therapy or after 3 months of endocrine therapy |
| Patient acceptability of WB-DWI assessed from questionnaires provided between WB-DWI scans and quantified using a 5-point Likert scale | 3 months | Patients will be monitored by routine CT scans after 3 cycles of cytotoxic/biological therapy or after 3 months of endocrine therapy |
| Comparison of patient acceptability to whole-body CT | 3 months | Patients will be monitored by routine CT scans after 3 cycles of cytotoxic/biological therapy or after 3 months of endocrine therapy |
Countries
United Kingdom
Outcome results
None listed