Sodium (23Na) MRI for Tumour Characterisation and Assessment of Therapy Response in Breast Cancer (NaRNIA)

NHS Foundation Trust

Status: Enrolling

Conditions: Breast Cancer

Treatments: Other: PET/MRI; Other: MRI

Study type: Observational

Funder types: Other

Identifiers

NCT03940092

260281

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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.

Trial design

65 participants in 3 patient groups

Healthy Volunteers

Description:

Healthy volunteers will be scheduled for an 23Na-MR examination

Treatment:

Other: MRI

Breast cancer patients (primary surgery)

Description:

Patients scheduled for primary surgery will undergo a single MR examination, involving 23Na-imaging prior to their planned surgery.

Treatment:

Other: MRI

Breast cancer patients (neoadjuvant chemotherapy)

Description:

Patients undergoing neo-adjuvant therapy will undertake up to two (2) combined PET/MR examinations with FDG. Examinations will be conducted at baseline and after 3-4 cycles of chemotherapy.

Treatment:

Other: PET/MRI