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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

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

Clinicaltrials.gov identifier NCT03940092

Recruitment Status Not yet recruiting

First Posted May 7, 2019

Last update posted January 7, 2020

Study Description

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:Breast Cancer
  • Intervention/Treatment: Other: MRI
    Other: PET/MRI
  • Phase: N/A
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
  • 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
  • Estimated Study Start Date: August 2020
  • Estimated Primary Completion Date: October 2021
  • Estimated Study Completion Date: March 2022
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: 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.
: 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.
: 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
Outcome Measures
  • 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
  • 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
Contacts

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

Locations

United Kingdom, Cambridgeshire
Cambridge University Hospitals NHS Foundation Trust
Cambridge

Sponsors and Collaborators

Cambridge University Hospitals NHS Foundation Trust

Investigators

Principal Investigator: Fiona Gilbert, FRCR University of Cambridge

More Information
  • Responsible Party: Cambridge University Hospitals NHS Foundation Trust
  • ClinicalTrials.gov Identifier: NCT03940092 History of Changes
  • Other Study ID Numbers: 260281
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: January 7, 2020
  • Last Verified: January 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Breast Neoplasms