Sodium (23Na) MRI for Tumour Characterisation and Assessment of Therapy Response in Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Image quality of 23Na-MRI in the breast evaluated radiologically after each 23Na-MRI scan in healthy volunteers and patients.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteers
- •Female, aged 18 years or above
- •Participant is willing and able to give informed consent for participation in the study.
- •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 exclusion criteria for patients
- •Has undergone chemotherapy or hormonal therapy for breast cancer in the previous 12 months
- •Previous surgery or radiotherapy for breast cancer to the ipsilateral breast within the past 4 months
- •Previous surgery for benign breast disease within the past 4 months
- •History of kidney disease or known allergic reaction to gadolinium contrast agent.
排除标准
- 未提供
结局指标
主要结局
Image quality of 23Na-MRI in the breast evaluated radiologically after each 23Na-MRI scan in healthy volunteers and patients.
时间窗: 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
次要结局
- Correlation of baseline 23Na-MRI with tissue markers of metabolism(Up to 2 years)
- Change in 23Na-MRI measurements in breast cancer patients undergoing neo-adjuvant therapy(Up to 2 years)
研究者
Professor Fiona J Gilbert
Head of Department of Radiology; Consultant Radiologist
Cambridge University Hospitals NHS Foundation Trust