Breast Cancer
Conditions
Brief summary
The scope of this study is the methodological development and optimisation of sodium MRI (23Na-MRI) protocols for breast cancer imaging. The study further proposes to utilise biomarkers obtained from 23Na-imaging (cell integrity), FDG-PET (metabolism), multi-parametric MRI (perfusion, vascularity, cellularity, morphology) to generate parameter maps specific for physiological processes in breast cancer.
Detailed description
This is a prospective, non-randomised, exploratory study on ≤20 healthy female volunteers (\>18 years), and ≤45 female patients (\>18 years) diagnosed with primary breast cancer. Healthy volunteers (n≤20) will be scheduled to undergo an 23Na-MR examination. Patients scheduled for primary surgery (n≤30) will undergo a single MR examination, involving 23Na-imaging prior to their planned surgery. Immunohistochemical analysis will be performed on surgical tissue specimens to determine tissue markers of interest for correlation with the imaging findings. Patients undergoing neo-adjuvant therapy (n≤15) will undertake up to two (2) combined PET/MR examinations with FDG (18F-2-fluoro-2-deoxy-D-glucose) and 23Na-MRI. Patient imaging will occur at two time points prior to their planned surgery: (i) baseline (prior to initiation of treatment) and (ii) mid-treatment (after 3-4 cycles of chemotherapy). Histopathological analysis will be performed on pre-treatment biopsies for histological markers of interest for correlation with the imaging findings.
Interventions
OTHERMRI
This is a prospective, non-randomised, exploratory study on healthy female volunteers (\>18 years), and female patients (\>18 years) diagnosed with primary breast cancer. Healthy volunteers will be scheduled for an 23Na-MRI examination. Patients scheduled for primary surgery will undergo an MR examination, involving 23Na-imaging prior to their planned surgery.
OTHERPET/MRI
Patients undergoing neo-adjuvant chemotherapy will undertake up to two (2) combined PET/MR examinations with FDG and 23Na-MRI
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Healthy Volunteers * Female, aged 18 years or above * Participant is willing and able to give informed consent for participation in the study. Patients * Female, aged 18 years or above * Pathologically confirmed primary breast cancer * Tumour \>1 cm diameter on mammography and/or ultrasound.
Exclusion criteria
for healthy volunteers and patients: * Pregnant or lactating; * History of serious breast trauma within past 3 months * Implants known to be contraindicated at 3T MRI * Significant or uncontrolled medical problems which according to the opinion of the Principal Investigator render the participant unsuitable for participation in the study * Underlying conditions, including but not limited to medical or psychiatric conditions, which in the opinion of the Principal Investigator would preclude the participant from adhering to the study protocol or completing the study per protocol * Lacking the capacity to provide informed consent. Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Image quality of 23Na-MRI in the breast evaluated radiologically after each 23Na-MRI scan in healthy volunteers and patients. | Up to 2 years | Development and optimisation of protocols for the imaging of intra and extracellular 23Na in breast cancer. Protocols will be developed on healthy volunteers and applied on cohorts of breast cancer patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of baseline 23Na-MRI with tissue markers of metabolism | Up to 2 years | Correlation of baseline tissue sodium concentration as measured by 23Na-MRI with tissue markers of metabolism obtained from histopathological analysis of diagnostic biopsies/specimens |
| Change in 23Na-MRI measurements in breast cancer patients undergoing neo-adjuvant therapy | Up to 2 years | Feasibility of measuring changes 23Na-MRI measurements in breast cancer patients undergoing neo-adjuvant therapy |
Other
| Measure | Time frame | Description |
|---|---|---|
| Correlate changes between 23Na-MRI measurements and changes in FDG-PET and multi-parametric proton-MR imaging | Up to 2 years | Correlation of changes between 23Na-MRI measurements and changes in FDG-PET/multi-parametric proton-MR imaging |
Countries
United Kingdom
Contacts
Primary ContactFiona Gilbert, FRCR
Outcome results
None listed