Comparative Evaluation of Contrast-Enhanced MRI and FDG-PET/CT in Spinal Pathology: Image Quality and Short-Term Renal-Hematologic Safety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
研究概览
简要总结
This prospective comparative observational study evaluates image quality characteristics and short-term physiological effects associated with contrast-enhanced magnetic resonance imaging (MRI) and fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) in patients with cervical and lumbar spinal pathologies.
A total of 120 adult participants undergo either contrast-enhanced MRI or FDG-PET/CT as part of routine clinical evaluation. Image quality is assessed using quantitative metrics, including signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR), as well as qualitative Visual Grading Analysis (VGA) performed by blinded radiologists. Short-term physiological effects are evaluated using blood urea nitrogen (BUN), estimated glomerular filtration rate (eGFR), and hemoglobin measurements obtained before imaging and 48 hours after imaging.
The study aims to compare image quality characteristics and short-term physiological parameters associated with these imaging modalities and to examine the influence of age group and spinal region on imaging performance.
详细描述
Background and Rationale
Magnetic resonance imaging (MRI) and fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) are widely used imaging modalities for the evaluation of cervical and lumbar spinal disorders. MRI primarily provides high-resolution anatomical information, whereas FDG-PET/CT provides metabolic and functional information that may assist in the assessment of inflammatory, infectious, degenerative, and neoplastic spinal conditions. Although both modalities are routinely used in clinical practice, differences in image quality characteristics and short-term physiological effects associated with imaging procedures remain areas of interest.
Study Design
This study is a prospective comparative observational study designed to evaluate image quality characteristics and short-term physiological effects associated with contrast-enhanced MRI and FDG-PET/CT in adult patients with cervical or lumbar spinal pathologies. A total of 120 participants are included, with 60 participants undergoing contrast-enhanced MRI and 60 participants undergoing FDG-PET/CT according to routine clinical indications and standard institutional workflows.
The study is non-interventional. No experimental treatments, investigational drugs, or deviations from standard clinical care are introduced. All imaging procedures are performed according to established institutional protocols and manufacturer recommendations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older.
- •Clinically suspected or confirmed cervical or lumbar spinal pathology.
- •Presence of symptoms suggestive of spinal disease, including radiculopathy, localized spinal pain, neurological deficits, or suspected metastatic involvement.
- •Referred for diagnostic evaluation with contrast-enhanced MRI or FDG-PET/CT according to routine clinical indications.
- •Availability of baseline clinical and laboratory data, including renal function assessment.
- •Ability to provide informed consent.
排除标准
- •Severe renal impairment (eGFR <30 mL/min/1.73 m²) or acute kidney injury.
- •Known hypersensitivity to gadolinium-based contrast agents or 18F-FDG.
- •Contraindications to MRI, including non-compatible metallic implants or severe claustrophobia.
- •Pregnancy or breastfeeding.
- •Uncontrolled diabetes mellitus (blood glucose >200 mg/dL at the time of PET/CT examination).
- •Active systemic infection or inflammatory condition requiring immediate treatment.
- •Inability to complete the required imaging procedures.
- •Incomplete clinical, laboratory, or imaging data required for study evaluation.
研究者
Ahmed Elgendi
Research Scientist
Cairo University