Breast CancerNaRNIANCT03940092
Sodium (23Na) MRI for Tumour Characterisation and Assessment of Therapy Response in Breast Cancer
An observational study of Breast Cancer, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MRI and PET/MRI
- How many people
- 65 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Aug 2020to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0QQ
Amy J Frary, BSc, 01223767926, af557@medschl.cam.ac.uk
Fiona J Gilbert, FRCR, 01223746439, fjg28@medschl.cam.ac.uk
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- MRI, PET/MRI
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
Also called 23Na-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/MRIOther
Also called FDG-PET/MRI
Patients undergoing neo-adjuvant chemotherapy will undertake up to two (2) combined PET/MR examinations with FDG and 23Na-MRI
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Healthy volunteers will be scheduled for an 23Na-MR examination Receives: 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. Receives: 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. Receives: Other: PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 2 years
Secondary outcomes (2)
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
Measured: 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
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start13 Aug 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Fiona J Gilbert, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Fiona Gilbert, FRCR, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940092
- Sponsor's protocol ID
- 260281
- Acronym
- NaRNIA
- Status last verified
- Feb 2022
- First submitted
- 30 Apr 2019
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium (23Na) MRI for Tumour Characterisation and Assessment of Therapy Response in Breast Cancer
- ClinicalTrials.gov ID
- NCT03940092
- Acronym / sponsor ID
- NaRNIA / 260281
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Other: MRIHealthy volunteers will be scheduled for an 23Na-MR examination |
| Breast cancer patients (primary surgery) | – | Other: MRIPatients scheduled for primary surgery will undergo a single MR examination, involving 23Na-imaging prior to their planned surgery. |
| Breast cancer patients (neoadjuvant chemotherapy) | – | Other: PET/MRIPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIAlso: 23Na-MRIThis 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 | Breast cancer patients (primary surgery), Healthy Volunteers |
| PET/MRIAlso: FDG-PET/MRIPatients undergoing neo-adjuvant chemotherapy will undertake up to two (2) combined PET/MR examinations with FDG and 23Na-MRI | Other | Breast cancer patients (neoadjuvant chemotherapy) |
Primary outcome
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
2 secondary outcomes
Correlation of baseline 23Na-MRI with tissue markers of metabolism
Time frame: Up to 2 years
Change in 23Na-MRI measurements in breast cancer patients undergoing neo-adjuvant therapy
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fiona Gilbert, FRCR principal investigator
University of Cambridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fiona Gilbert, FRCR (01223746439, fjg28@medschl.cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2022.