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Completed
NCT07640386
Comparative Evaluation of Contrast-Enhanced MRI and FDG-PET/CT in Spinal Pathology: Image Quality and Short-Term Renal-Hematologic Safety
Conditions: Short-Term Renal-Hematologic Safety, Contrast-Enhanced MRI and FDG-PET/CT, Spinal Pathology
Sex: All
Healthy volunteers: Yes
Enrollment: 120
Sponsor: Cairo University
Location: (MISR University Scientific Research Innovation Committee, Giza Giza Governorate
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.
Eligibility Criteria
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 \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.
Source: ClinicalTrials.gov (NCT07640386). StuddyBuddy aggregates publicly available trial information.