sing advanced MRI to explore metabolism and tissue structure in multiple sclerosis (MISSION MIMS)

Not Applicable

• Conditions: Multiple sclerosis; Nervous System Diseases

• Registration Number: ISRCTN10088443
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-21
• Last Update Posted: 5 August 2024
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

MS patients (for C13 and DMI)
1. Be aged 18 years or older.
2. Have a confirmed diagnosis of MS.
3. Be aware of and understand their diagnosis.
4. Be able to provide written informed consent according to ICH/GCP, national and local regulations.
5. Be willing and able to comply with scheduled visits, laboratory tests, imaging and other study procedures.

Healthy volunteers (C13 and DMI)
1. Be aged 18 years or older
2. Be able to provide written informed consent according to ICH/GCP, national and local regulations
3. Be willing and able to comply with scheduled visits, laboratory tests, imaging and other study procedures

Exclusion Criteria

MS patients (for C13 and DMI)
1. Have uncontrolled diabetes or glucose deranging conditions, or treatment that would cause such effects.
2. Have any medical condition that may increase the risk associated with study participation or in the judgement of the investigators make it unsuitable for the patient to enter the study.
3. Have a known allergy, adverse reaction or contraindication to any of the injected contrast agents used in this study including gadolinium contrast agents or pyruvate.
4. Be otherwise unsuitable for MRI e.g. having a permanent pacemaker, severe obesity or inability to lie still.
5. Be pregnant or breastfeeding

Healthy volunteers (for C13 and DMI)
1. Have uncontrolled diabetes or glucose deranging conditions, or treatment that would cause such effects. The significance of this will be determined by the research team.
2. Have any medical condition that may increase the risk associated with study participation, or in the judgement of the investigators make it unsuitable for the patient to enter the study.
3. Have a known allergy, adverse reaction or contraindication to any of the injected contrast agents used in this study including gadolinium contrast agents or pyruvate.
4. Be otherwise unsuitable for MRI e.g. having a permanent pacemaker, severe obesity or inability to lie still.
5. Be pregnant or breastfeeding
6. Any previous or current neurological condition deemed to be significant by the research team.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sing MRI imaging:<br>1. 13C. Spatial maps of area under the curve (AUC) timecourse sums of signals from<br>hyperpolarized pyruvate, lactate, and any other metabolites detected, and ratios between these metabolite AUCs. Also estimates of the kinetic rate constants of conversion between injected tracer pyruvate and the metabolites formed (lactate, other). The timecourse typically covers approximately 1 minute beginning approximately 16 seconds after the start of injection.<br>2. DMI. Spectral peak intensity ratios between deuterated water, glucose, glutamate (brain only), lactate and lipids. These will be either in spatial maps derived from 3D spectroscopic imaging, or in unlocalized spectra from the whole sensitive volume of the coil.

Secondary Outcome Measures

Name	Time	Method
Sensitivity and spatial resolution of carbon-13 imaging of pyruvate and lactate in the human brain as measured by computing the signal-to-noise ratio in images of the area-under-the-curve of the timecourse signals of pyruvate, lactate and bicarbonate.