Metabolic MRI of amyotrophic lateral sclerosis and mini strokes

MRI of neurometabolic impairment in ALS and TIA using hyperpolarized pyruvate

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-000352-36-DK

Enrollment

Registered

2020-02-13

Start date

2020-04-27

Completion date

Unknown

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic lateral sclerosis Transient ischemic attack MedDRA version: 21.1 Level: PT Classification code 10002026 Term: Amyotrophic lateral sclerosis System Organ Class: 10029205 - Nervous system disorders

Interventions

Product Name: Hyperpolarized [1-13C]pyruvate Pharmaceutical Form: Concentrate and solvent for solution for infusion INN or Proposed INN: SODIUM PYRUVATE Other descriptive name: SODIUM PYRUVATE Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All participants: - Aged 18 – 85 years. The age and gender of the healthy controls of the main study will be matched to the patients in ALS and TIA groups - Pre-menopausal women must be confirmed non-pregnant by an onsite test ALS group: - Fulfilling the 2015 revised El Escorial criteria - Upper motor neuron symptoms TIA group: - TIA within the last 10 days. TIA is defined as symptoms shorter than 24 hours (time definition) with a likely vascular genesis (mimics such as urinary tract infection, hypoglycemia and migraine are excluded) - Symptoms must include unilateral weakness of face and/or limb - Symptom duration > 10 minutes Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 21

Exclusion criteria

Exclusion criteria: Contraindications for MRI with contrast: - Chronic kidney disease - Significant cardiac disease such as severe left ventricular outflow obstruction - Significant obstructive lung disease or severe asthma - Pacemaker, neurostimulator or cholera implant - Metal foreign bodies such as fragments and irremovable piercings - Unsafe medical implants (safety of heart valves, hips and the like must be confirmed) - Intracranial clips or coils - Claustrophobia - Largest circumference including arms > 160 cm Competing neurological, psychiatric, liver or systemic disease including diabetes (except prior TIA, unspecific brain MRI findings, hypertension, atherosclerosis and hyperlipidemia/cholesterolemia which are allowed)

Design outcomes

Primary

Measure	Time frame
Main Objective: This project seeks to detect and characterize metabolic impairment in patients with amyotrophic lateral sclerosis and patients with a transient ischemic attack with a new MRI technique termed Hyperpolarized Pyruvate MRI. ;Secondary Objective: Not applicable;Primary end point(s): Cerebral metabolism as assessed with 13C label exchange from hyperpolarized pyruvate to bicarbonate, lactate and alanine. ;Timepoint(s) of evaluation of this end point: After the scan.	—

Measure

Time frame

Main Objective: This project seeks to detect and characterize metabolic impairment in patients with amyotrophic lateral sclerosis and patients with a transient ischemic attack with a new MRI technique termed Hyperpolarized Pyruvate MRI. ;Secondary Objective: Not applicable;Primary end point(s): Cerebral metabolism as assessed with 13C label exchange from hyperpolarized pyruvate to bicarbonate, lactate and alanine. ;Timepoint(s) of evaluation of this end point: After the scan.

—

Secondary

Measure	Time frame
Secondary end point(s): Disease characterization from clinical examination, interviews and patient records. ;Timepoint(s) of evaluation of this end point: After the scan.	—

Countries

Denmark

Contacts

Public ContactThe MR Research Centre

Aarhus University

cl@clin.au.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026