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Exploring new MRI techniques - a study in healthy volunteers and healthy patients

Not Applicable
Conditions
Healthy volunteers and healthy patients with known specific genotypes
Not Applicable
Registration Number
ISRCTN13008110
Lead Sponsor
Cambridge University Hospitals NHS Foundation Trust
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Ongoing
Sex
All
Target Recruitment
120
Inclusion Criteria

Inclusion criteria for healthy volunteers:
1. Over 18 years old
2. Able to and provide written informed consent to participate
3. If female, postmenopausal or if women of childbearing potential (WOCBP) using a suitable form of contraception
4. Capable of undergoing a minimum of one study visit

Inclusion criteria for healthy patients at risk for hereditary metabolic disease:
1. Over 18 years old
2. Able to and provide written informed consent to participate
3. If female, postmenopausal or if of childbearing potential (WOCBP) using a suitable form of contraception
4. Capable of undergoing a minimum of one study visit
5. Carrying a pathogenic variant in the genes for succinate dehydrogenase and undergoing asymptomatic surveillance but without tumour manifestation

Exclusion Criteria

The presence of any of the following will preclude participation as determined by the delegated investigator:
1. Contraindication or inability to tolerate MRI
2. Pregnant or actively breastfeeding woman
3. If using an intrauterine contraceptive device (IUCD) as a method of contraception the device should be MRI-safe at 3 T (researcher to confirm)
4. Clinically significant cardiac, pulmonary or neurological diseases as determined by the investigators
5. Laboratory abnormalities that may impact the study results although no screening will be required for entry into the study.
6. Any other significant medical or psychiatric history rendering the subject ineligible as deemed by the investigators

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
sing MRI imaging:<br>1. 13C. Spatial maps of area under the curve (AUC) timecourse sums of signals from 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.<br>3. Sodium. Maps of estimated millimolar sodium content over the 3D volume of tissue investigated. Optionally also maps of the ratio of intracellular-weighted signal to total sodium signal.<br>
Secondary Outcome Measures
NameTimeMethod
There are no secondary outcome measures
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