Comparative Evaluation of Contrast-Enhanced MRI and FDG-PET/CT in Spinal Pathology: Image Quality… (NCT07640386) | Clinical Trial Compass
CompletedNot Applicable
Comparative Evaluation of Contrast-Enhanced MRI and FDG-PET/CT in Spinal Pathology: Image Quality and Short-Term Renal-Hematologic Safety
Egypt120 participantsStarted 2025-04-05
Plain-language summary
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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quantitative Image Quality Assessment
Timeframe: Assessed at the imaging visit (up to 1 day).