Comparative Evaluation of Contrast-Enhanced MRI and FDG-PET/CT in Spinal Pathology: Image Quality and Short-Term Renal-Hematologic Safety

NCT07640386 | Completed DMC

• 1 other identifier: DDMFDW6dc1
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Short-Term Renal-Hematologic Safety; Contrast-Enhanced MRI and FDG-PET/CT; Spinal Pathology

Keywords

Magnetic Resonance Imaging; FDG-PET/CT; Spine Imaging; Image Quality; Signal-to-Noise Ratio; Contrast-to-Noise Ratio; Visual Grading Analysis

Outcome Measures

Primary Outcomes (1)

• Quantitative Image Quality Assessment

  Secondary Outcome Measure 1 Outcome Measure: Blood Urea Nitrogen (BUN) Description: Change in serum blood urea nitrogen concentration following imaging procedures. Time Frame: Baseline (pre-imaging) and 48 hours post-imaging. Unit of Measure: mg/dL Secondary Outcome Measure 2 Outcome Measure: Estimated Glomerular Filtration Rate (eGFR) Description: Change in estimated glomerular filtration rate following imaging procedures. Time Frame: Baseline (pre-imaging) and 48 hours post-imaging. Unit of Measure: mL/min/1.73 m² Secondary Outcome Measure 3 Outcome Measure: Hemoglobin Level Description: Change in hemoglobin concentration following imaging procedures. Time Frame: Baseline (pre-imaging) and 48 hours post-imaging. Unit of Measure: g/dL Secondary Outcome Measure 4 Outcome Measure: Visual Grading Analysis (VGA) Score Description: Qualitative image quality assessment performed by blinded radiologists to evaluate anatomical clarity, lesion delineation, image contrast, and

  Assessed at the imaging visit (up to 1 day).

Secondary Outcomes (1)

• Comparative Evaluation of Image Quality and Short-Term Physiological Effects of Contrast-Enhanced MRI versus FDG-PET/CT in Cervical and Lumbar Spine Pathologies

  For image quality assessment: At the time of imaging For short-term physiological effects (BUN, eGFR, hemoglobin): Baseline (pre-imaging) and 48 hours post-imaging

Study Arms (1)

patient allocation to MRI (n=60) and FDG-PET/CT (n=60) groups with stratification by spinal re-gion

Eligibility Criteria

• Gender Eligibility Details: Inclusion Criteria: Age ≥ 18 years. Clinical symptoms suggestive of cervical or lumbar pathology (e.g., radiculopathy, localized pain, suspected metastasis). Preliminary diagnostic suggestion from prior radiography or non-contrast CT. Exclusion Criteria: Severe renal impairment (estimated Glomerular Filtration Rate, eGFR \< 30 mL/min/1.73m²) or history of acute kidney injury. A total of 120 consecutive patients with clinically indicated cervical or lumbar spinal pathologies were enrolled. Patients were Known hypersensitivity to gadolinium-based metabolic tracerts or FDG. Standard contraindications to MRI (e.g., non-compatible metallic implants, severe claustrophobia). Pregnancy or lactation. Uncontrolled diabetes mellitus (blood glucose \>200 mg/dL at the time of PET/CT). Active systemic infection or inflammatory condition requiring immediate treatment.Adverse Event Monitoring: Allergic reactions, NSF risk, radiation nau-sea tracked via CTCAE v5.0; no serious adverse events occurred
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from the general population through community outreach, advertisements, and screening visits. Individuals who meet the eligibility criteria will be invited to participate.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

(MISR University Scientific Research Innovation Committee,

Giza, Giza Governorate, 43556, Egypt

Location

Related Publications (1)

• References 1. Altman, D.G. Practical Statistics for Medical Research (1st ed.); Chapman and Hall/CRC, 1990. 2. Andreucci, M.; Solomon, R.; Tasanarong, A. Side effects of radiographic contrast media: pathogenesis, risk factors, and pre-vention. Biomed Res Int. 2014, 2014, 741018. 3. Association, W.M. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. Jama 2013, 310, 2191-4. 4. Bajwa, H.; Sritharan, T.; Botha, T.; et al. Assessment of cervical spine CT by an image quality audit using qualitative and quantitative methods. J Med Imaging Radiat Oncol. 2025, 69, 7-16. 5. Benchoufi, M.; Matzner-Lober, E.; Molinari, N.; et al. Interobserver agreement issues in radiology. Diagn Interv Imaging 2020, 101, 639-41. 6. Beyer, T.; Bailey, D.L.; Birk, U.J.; et al. Medical Physics and Imaging-A Timely Perspective. Front. Phys. 2021, 9, 634693. 7. Boellaard, R.; Delgado-Bolton, R.; Oyen, W.J.; et al. FDG PET/CT: EANM procedure guidelines for tumour imaging: version 2.0. Eur J Nucl Med Mol Imaging. 2015, 42, 328-54. 8. Boos, N.; Rieder, R.; Schade, V.; et al. The Imaging characteristics of Magnetic Resonance Imaging, Work Perception, and Psychosocial Factors in Identifying Symptomatic Disc Herniations. Spine 1995, 20. 9. Boriani, L.; Zamparini, E.; Albrizio, M.; et al. Spine Infections: The Role of Fluorodeoxyglucose Positron Emission Tomography (FDG PET) in the Context of the Actual Diagnosis Guideline. Curr Med Imaging 2022, 18, 216-30. 10. Brinjikji, W.; Luetmer, P.H.; Comstock, B.; et al. Systematic literature review of imaging features of spinal degeneration in asymptomatic populations. AJNR Am J Neuroradiol. 2015, 36, 811-6. 11. Brown, T.F.; Yasillo, N.J. Radiation safety considerations for PET centers. J Nucl Med Technol. 1997, 25, 98-102; quiz 4-5. 12. Burmeister, H.P.; Baltzer, P.A.; Möslein, C.; et al. Visual grading characteristics (VGC) analysis of diagnostic image quality for high resolution 3 Tesla MRI vol

  RESULT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: June 10, 2026
• Study Start: April 5, 2025
• Primary Completion: November 3, 2025
• Study Completion: January 1, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-06

Locations

EG (1)