Clinical trial · Observational
Sodium (23Na) MRI for Tumour Characterisation and Assessment of Therapy Response in Breast Cancer
NCT03940092CI-TRIAL-00056786NaRNIAunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI | Other | — | UNRESOLVED |
| PET/MRI | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.