Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-02-11 @ 10:30 PM
Study NCT ID:
NCT03940092
Status:
RECRUITING
Last Update Posted:
2022-02-28
First Post:
2019-04-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sodium (23Na) MRI for Tumour Characterisation and Assessment of Therapy Response in Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '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.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-24', 'studyFirstSubmitDate': '2019-04-30', 'studyFirstSubmitQcDate': '2019-05-04', 'lastUpdatePostDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Correlate changes between 23Na-MRI measurements and changes in FDG-PET and multi-parametric proton-MR imaging', 'timeFrame': 'Up to 2 years', 'description': 'Correlation of changes between 23Na-MRI measurements and changes in FDG-PET/multi-parametric proton-MR imaging'}], 'primaryOutcomes': [{'measure': 'Image quality of 23Na-MRI in the breast evaluated radiologically after each 23Na-MRI scan in healthy volunteers and patients.', 'timeFrame': 'Up to 2 years', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Correlation of baseline 23Na-MRI with tissue markers of metabolism', 'timeFrame': 'Up to 2 years', 'description': 'Correlation of baseline tissue sodium concentration as measured by 23Na-MRI with tissue markers of metabolism obtained from histopathological analysis of diagnostic biopsies/specimens'}, {'measure': 'Change in 23Na-MRI measurements in breast cancer patients undergoing neo-adjuvant therapy', 'timeFrame': 'Up to 2 years', 'description': 'Feasibility of measuring changes 23Na-MRI measurements in breast cancer patients undergoing neo-adjuvant therapy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy female volunteers (n≤20), aged 18 years or above.\n\nFemale patients (n≤45) aged 18 years or above, with pathologically confirmed primary breast cancer undergoing primary surgery or neo-adjuvant therapy.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy Volunteers\n\n* Female, aged 18 years or above\n* Participant is willing and able to give informed consent for participation in the study.\n\nPatients\n\n* Female, aged 18 years or above\n* Pathologically confirmed primary breast cancer\n* Tumour \\>1 cm diameter on mammography and/or ultrasound.\n\nExclusion Criteria for healthy volunteers and patients:\n\n* Pregnant or lactating;\n* History of serious breast trauma within past 3 months\n* Implants known to be contraindicated at 3T MRI\n* Significant or uncontrolled medical problems which according to the opinion of the Principal Investigator render the participant unsuitable for participation in the study\n* 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\n* Lacking the capacity to provide informed consent.\n\nAdditional exclusion criteria for patients\n\n* Has undergone chemotherapy or hormonal therapy for breast cancer in the previous 12 months\n* Previous surgery or radiotherapy for breast cancer to the ipsilateral breast within the past 4 months\n* Previous surgery for benign breast disease within the past 4 months\n* History of kidney disease or known allergic reaction to gadolinium contrast agent.'}, 'identificationModule': {'nctId': 'NCT03940092', 'acronym': 'NaRNIA', 'briefTitle': 'Sodium (23Na) MRI for Tumour Characterisation and Assessment of Therapy Response in Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Cambridge University Hospitals NHS Foundation Trust'}, 'officialTitle': 'Sodium (23Na) MRI for Tumour Characterisation and Assessment of Therapy Response in Breast Cancer', 'orgStudyIdInfo': {'id': '260281'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Volunteers', 'description': 'Healthy volunteers will be scheduled for an 23Na-MR examination', 'interventionNames': ['Other: MRI']}, {'label': 'Breast cancer patients (primary surgery)', 'description': 'Patients scheduled for primary surgery will undergo a single MR examination, involving 23Na-imaging prior to their planned surgery.', 'interventionNames': ['Other: MRI']}, {'label': 'Breast cancer patients (neoadjuvant chemotherapy)', 'description': '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.', 'interventionNames': ['Other: PET/MRI']}], 'interventions': [{'name': 'MRI', 'type': 'OTHER', 'otherNames': ['23Na-MRI'], 'description': 'This is a prospective, non-randomised, exploratory study on healthy female volunteers (\\>18 years), and female patients (\\>18 years) diagnosed with primary breast cancer.\n\nHealthy volunteers will be scheduled for an 23Na-MRI examination.\n\nPatients scheduled for primary surgery will undergo an MR examination, involving 23Na-imaging prior to their planned surgery.', 'armGroupLabels': ['Breast cancer patients (primary surgery)', 'Healthy Volunteers']}, {'name': 'PET/MRI', 'type': 'OTHER', 'otherNames': ['FDG-PET/MRI'], 'description': 'Patients undergoing neo-adjuvant chemotherapy will undertake up to two (2) combined PET/MR examinations with FDG and 23Na-MRI', 'armGroupLabels': ['Breast cancer patients (neoadjuvant chemotherapy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CB2 0QQ', 'city': 'Cambridge', 'state': 'Cambridgeshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Amy J Frary, BSc', 'role': 'CONTACT', 'email': 'af557@medschl.cam.ac.uk', 'phone': '01223767926'}, {'name': 'Fiona J Gilbert, FRCR', 'role': 'CONTACT', 'email': 'fjg28@medschl.cam.ac.uk', 'phone': '01223746439'}], 'facility': 'Cambridge University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}], 'centralContacts': [{'name': 'Fiona Gilbert, FRCR', 'role': 'CONTACT', 'email': 'fjg28@medschl.cam.ac.uk', 'phone': '01223746439'}], 'overallOfficials': [{'name': 'Fiona Gilbert, FRCR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cambridge'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cambridge University Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Department of Radiology; Consultant Radiologist', 'investigatorFullName': 'Professor Fiona J Gilbert', 'investigatorAffiliation': 'Cambridge University Hospitals NHS Foundation Trust'}}}}