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

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ClinicalTrials.gov Identifier: NCT03940092
Recruitment Status : Recruiting
First Posted : May 7, 2019
Last Update Posted : February 28, 2022
Sponsor:
Information provided by (Responsible Party):
Professor Fiona J Gilbert, Cambridge University Hospitals NHS Foundation Trust

Study Description
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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.

Condition or disease Intervention/treatment
Breast Cancer 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 Design
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Study Type : Observational
Estimated Enrollment : 65 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sodium (23Na) MRI for Tumour Characterisation and Assessment of Therapy Response in Breast Cancer
Actual Study Start Date : August 13, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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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 Name: 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 Name: 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 Name: FDG-PET/MRI


Outcome Measures
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Primary Outcome Measures :
  1. Image quality of 23Na-MRI in the breast evaluated radiologically after each 23Na-MRI scan in healthy volunteers and patients. [ Time Frame: Up to 2 years ]
    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


Secondary Outcome Measures :
  1. Correlation of baseline 23Na-MRI with tissue markers of metabolism [ Time Frame: Up to 2 years ]
    Correlation of baseline tissue sodium concentration as measured by 23Na-MRI with tissue markers of metabolism obtained from histopathological analysis of diagnostic biopsies/specimens

  2. Change in 23Na-MRI measurements in breast cancer patients undergoing neo-adjuvant therapy [ Time Frame: Up to 2 years ]
    Feasibility of measuring changes 23Na-MRI measurements in breast cancer patients undergoing neo-adjuvant therapy


Other Outcome Measures:
  1. Correlate changes between 23Na-MRI measurements and changes in FDG-PET and multi-parametric proton-MR imaging [ Time Frame: Up to 2 years ]
    Correlation of changes between 23Na-MRI measurements and changes in FDG-PET/multi-parametric proton-MR imaging


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.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03940092


Contacts
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Contact: Fiona Gilbert, FRCR 01223746439 fjg28@medschl.cam.ac.uk

Locations
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United Kingdom
Cambridge University Hospitals NHS Foundation Trust Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Contact: Amy J Frary, BSc    01223767926    af557@medschl.cam.ac.uk   
Contact: Fiona J Gilbert, FRCR    01223746439    fjg28@medschl.cam.ac.uk   
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Fiona Gilbert, FRCR University of Cambridge
More Information
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Responsible Party: Professor Fiona J Gilbert, Head of Department of Radiology; Consultant Radiologist, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03940092    
Other Study ID Numbers: 260281
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: February 28, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases