Using sodium MRI to assess breast cancer and treatment response
Sodium (23Na) MRI for Tumour Characterisation and Assessment of Therapy Response in Breast Cancer
This study is testing a new type of MRI that uses sodium to see how breast cancer behaves and responds to treatment in women with the disease and healthy volunteers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 65 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Cambridge University Hospitals NHS Foundation Trust Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Cambridge, Cambridgeshire) |
| Trial ID | NCT03940092 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on developing and optimizing sodium MRI (23Na-MRI) protocols for imaging breast cancer. It involves healthy female volunteers and female patients diagnosed with primary breast cancer, who will undergo various imaging examinations, including 23Na-MRI and FDG-PET. The study aims to correlate imaging findings with histopathological markers from tissue specimens to enhance understanding of tumor characteristics and treatment response. The research will provide insights into physiological processes in breast cancer through advanced imaging techniques.
Who should consider this trial
Good fit: Ideal candidates include females aged 18 years or older with pathologically confirmed primary breast cancer and tumors larger than 1 cm.
Not a fit: Patients who are pregnant, lactating, or have significant medical issues that prevent participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of breast cancer diagnosis and treatment monitoring.
How similar studies have performed: While the use of sodium MRI in breast cancer is an emerging field, similar imaging approaches have shown promise in other cancers, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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.
Where this trial is running
Cambridge, Cambridgeshire
- Cambridge University Hospitals NHS Foundation Trust — Cambridge, Cambridgeshire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Fiona Gilbert, FRCR — University of Cambridge
- Study coordinator: Fiona Gilbert, FRCR
- Email: fjg28@medschl.cam.ac.uk
- Phone: 01223746439
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.