Clinical trial NCT03940092: Sodium (23Na) MRI for Tumour Characterisation and Assessment of Therapy Response in Breast Cancer
Official title: Sodium (23Na) MRI for Tumour Characterisation and Assessment of Therapy Response in Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy female volunteers (n≤20), aged 18 years or above.

Female patients (n≤45) aged 18 years or above, with pathologically confirmed primary breast cancer undergoing primary surgery or neo-adjuvant therapy.

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.

Eligibility 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.

Primary outcomes:
measure: Image quality of 23Na-MRI in the breast evaluated radiologically after each 23Na-MRI scan in healthy volunteers and patients.
timeFrame: Up to 2 years
Secondary outcomes:
measure: Correlation of baseline 23Na-MRI with tissue markers of metabolism
timeFrame: Up to 2 years
measure: Change in 23Na-MRI measurements in breast cancer patients undergoing neo-adjuvant therapy
timeFrame: Up to 2 years
Other outcomes:
measure: Correlate changes between 23Na-MRI measurements and changes in FDG-PET and multi-parametric proton-MR imaging
timeFrame: Up to 2 years
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
state: Cambridgeshire
Study officials:
affiliation: University of Cambridge
name: Fiona Gilbert, FRCR
role: PRINCIPAL_INVESTIGATOR
References: