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

Breast Cancer Clinical Trial

— NaRNIA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03940092
• Other study ID #: 260281
• Status: Recruiting
• Start date: August 13, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2022
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: Fiona Gilbert, FRCR
• Phone: 01223746439
• Email: fjg28[@]medschl.cam.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• MRI
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.
• PET/MRI
Patients undergoing neo-adjuvant chemotherapy will undertake up to two (2) combined PET/MR examinations with FDG and 23Na-MRI

Locations

Country	Name	City	State
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge	Cambridgeshire

Sponsors (1)

Lead Sponsor	Collaborator
Cambridge University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlate changes between 23Na-MRI measurements and changes in FDG-PET and multi-parametric proton-MR imaging	Correlation of changes between 23Na-MRI measurements and changes in FDG-PET/multi-parametric proton-MR imaging	Up to 2 years
Primary	Image quality of 23Na-MRI in the breast evaluated radiologically after each 23Na-MRI scan in healthy volunteers and patients.	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	Up to 2 years
Secondary	Correlation of baseline 23Na-MRI with tissue markers of metabolism	Correlation of baseline tissue sodium concentration as measured by 23Na-MRI with tissue markers of metabolism obtained from histopathological analysis of diagnostic biopsies/specimens	Up to 2 years
Secondary	Change in 23Na-MRI measurements in breast cancer patients undergoing neo-adjuvant therapy	Feasibility of measuring changes 23Na-MRI measurements in breast cancer patients undergoing neo-adjuvant therapy	Up to 2 years