NCT03940092

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 65 (estimated)
• Sponsor: Cambridge University Hospitals NHS Foundation Trust · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
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	PET/MRI	Patients undergoing neo-adjuvant chemotherapy will undertake up to two (2) combined PET/MR examinations with FDG and 23Na-MRI

Timeline

• Start date: 2020-08-13
• Primary completion: 2023-12-31
• Completion: 2025-12-31
• First posted: 2019-05-07
• Last updated: 2022-02-28

Locations

1 site across 1 country: United Kingdom