The 18-kDa translocator protein radioligand [18F]GE-180 as a diagnostic and prognostic biomarker following spinal cord injury: A PET-CT pilot study

South Australian Health and Medical Research Institute0 个研究点目标入组 24 人开始时间: 2018年11月30日最近更新: 2023年4月10日

适应症

试验速览

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•1.Male, or female
•2.Aged between 18 and 75 years (inclusive)
•6.Medically stable, in the opinion of the treating physician
•3.4.Have sustained a complete or incomplete, traumatic spinal cord injury, or, have a non-traumatic spinal cord injury (e.g. a spinal cord injury caused by multiple sclerosis, amyotrophic lateral sclerosis, cancer metastasis to spine)
•4.Have complete or incomplete SCI, taking complete as the absence of sensory and motor functions in the lowest sacral segments, as per the International Standard for the Neurological Classification of SCI (ISNCSCI) 2011 revision
•5.Have International Standard for the Neurological Classification of SCI (ISNCSCI) Grade A, Grade B, Grade C or Grade D at acute admission
•6.Have neurological level between C4 and L1, taking this as the most caudal segment with normal motor and sensory functions on both sides of the body (ISNCSCI; revised 2011)
•7.Have submitted to either spinal instrumentation (carbon fibre, or metal fixation in situ), or conservative stabilisation
•8.Are agreeable to sequence analysis for the r.s. 6971 phenotype

•1.Pregnant or breastfeeding
•2.Have history of stroke, or TBI, brachial plexus lesion, or any other serious medical condition; e.g. malignancies, psychiatric, or illicit drug-dependence, which is likely to influence the patient’s ability to participate
•3.Have active osteomyelitis, Paget’s disease, or severe kypho/scoliosis
•4.Have spasticity, or autonomic dysreflexia (AD) unresponsive to standard care, as advised by the treating physician
•5.Have pressure ulcer(s) on the pelves or proximal femur, or other contraindications to participating in the PET-CT imaging protocol, or outcome assessments, as advised by the treating physician
•6.Have medical history of alcohol dependence or medical/ cultural contraindication to alcohol exposure
•7.Have active, or previous participation in investigational drug study within 30 days of enrolment
•8.Considered unwilling, unable or unlikely to comply with the study protocol
•9.Have English language competency insufficient to understand research procedures, or are unable to provide informed consent.

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