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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: MRI; Other: PET/MRI

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.

• Study Type: Observational
• Enrollment (Anticipated): 65

Contacts and Locations

• Study Contact: Name: Fiona Gilbert, FRCR; Phone Number: 01223746439; Email: fjg28@medschl.cam.ac.uk

Study Locations

• United Kingdom
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
      • Recruiting
      • Cambridge University Hospitals NHS Foundation Trust
      • Contact: Amy J Frary, BSc; Phone Number: 01223767926; Email: af557@medschl.cam.ac.uk
      • Contact: Fiona J Gilbert, FRCR; Phone Number: 01223746439; Email: fjg28@medschl.cam.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Volunteers; Healthy volunteers will be scheduled for an 23Na-MR examination	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.; Other Names: 23Na-MRI
Breast cancer patients (primary surgery); Patients scheduled for primary surgery will undergo a single MR examination, involving 23Na-imaging prior to their planned surgery.	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.; Other Names: 23Na-MRI
Breast cancer patients (neoadjuvant chemotherapy); 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.	Other: PET/MRI; Patients undergoing neo-adjuvant chemotherapy will undertake up to two (2) combined PET/MR examinations with FDG and 23Na-MRI; Other Names: FDG-PET/MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Fiona Gilbert, FRCR, University of Cambridge

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 13, 2020
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2025

Study Registration Dates

• First Submitted: April 30, 2019
• First Submitted That Met QC Criteria: May 4, 2019
• First Posted (ACTUAL): May 7, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 28, 2022
• Last Update Submitted That Met QC Criteria: February 24, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 260281

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No