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

NCT03940092 | Unknown

• 1 other identifier: 260281
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Correlation of baseline 23Na-MRI with tissue markers of metabolism

  Up to 2 years

• Change in 23Na-MRI measurements in breast cancer patients undergoing neo-adjuvant therapy

  Up to 2 years

Other Outcomes (1)

• Correlate changes between 23Na-MRI measurements and changes in FDG-PET and multi-parametric proton-MR imaging

  Up to 2 years

Study Arms (3)

Healthy Volunteers

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

Other: 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

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

Interventions

MRI OTHER

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.

Also known as: 23Na-MRI

Breast cancer patients (primary surgery); Healthy Volunteers

PET/MRI OTHER

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

Also known as: FDG-PET/MRI

Breast cancer patients (neoadjuvant chemotherapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Cambridge University Hospitals NHS Foundation Trust

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Histopathological analysis will be performed on diagnostic biopsies and tumour specimens from participating breast cancer patients. Immunohistochemical staining will be performed on histological samples to assess tumour vascularity, metabolism, and other markers of interest for correlation with imaging findings.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Fiona Gilbert, FRCR

  University of Cambridge

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fiona Gilbert, FRCR

CONTACT

01223746439; fjg28@medschl.cam.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Radiology; Consultant Radiologist

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 7, 2019
• Study Start: August 13, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: February 28, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)