Short-Term Renal-Hematologic SafetyNCT07640386
Comparative Evaluation of Contrast-Enhanced MRI and FDG-PET/CT in Spinal Pathology: Image Quality and Short-Term Renal-Hematologic Safety
An observational study of Short-Term Renal-Hematologic Safety and Contrast-Enhanced MRI and FDG-PET/CT, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Short-Term Renal-Hematologic Safety, Contrast-Enhanced MRI and FDG-PET/CT, Spinal Pathology
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Apr 2025to 1 Jan 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
(MISR University Scientific Research Innovation Committee,
Giza, Giza Governorate, 43556
About this study
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.
Read the detailed description
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.
Study Population
Eligible participants are adults with clinically suspected or confirmed cervical or lumbar spinal pathology requiring advanced imaging evaluation. Conditions may include degenerative, inflammatory, infectious, neoplastic, traumatic, or post-surgical spinal disorders.
Imaging Procedures
MRI examinations are performed using a 3 Tesla scanner equipped with a dedicated spinal coil. Standard spinal imaging protocols include sagittal and axial T1-weighted and T2-weighted sequences. Intravenous gadolinium-based contrast administration is performed according to institutional guidelines and standard clinical practice.
FDG-PET/CT examinations are performed following standard patient preparation procedures, including fasting requirements and blood glucose assessment. Intravenous administration of 18F-fluorodeoxyglucose (FDG) is followed by image acquisition using routine clinical PET/CT protocols. CT acquisition is used for attenuation correction and anatomical localization according to institutional practice.
Image Quality Assessment
Quantitative image quality assessment includes measurement of signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) using standardized regions of interest. Measurements are performed using predefined image analysis procedures to ensure consistency across participants.
Qualitative image quality assessment is performed using Visual Grading Analysis (VGA). Independent blinded radiologists evaluate image quality using predefined criteria related to anatomical detail, tissue contrast, lesion conspicuity, image noise, and overall diagnostic usability.
Physiological and Safety Assessments
Short-term physiological effects associated with imaging procedures are evaluated using laboratory measurements obtained before imaging and 48 hours after imaging. Laboratory assessments include blood urea nitrogen (BUN), estimated glomerular filtration rate (eGFR), and hemoglobin concentration.
Routine safety monitoring is performed according to institutional standards. Adverse events associated with contrast administration or imaging procedures are documented and managed according to standard clinical protocols.
Subgroup Analyses
Prespecified subgroup analyses evaluate image quality metrics according to spinal region (cervical versus lumbar) and age group (50 years or younger versus older than 50 years). These analyses are intended to explore potential differences in imaging performance across clinically relevant patient subgroups.
Study Objectives
The primary objectives are to compare quantitative image quality metrics between contrast-enhanced MRI and FDG-PET/CT and to evaluate qualitative image quality using blinded radiologist assessment.
Secondary objectives include assessment of short-term changes in renal and hematologic laboratory parameters following imaging procedures performed as part of routine clinical care.
Ethics
The study is conducted in accordance with applicable ethical principles, institutional policies, and approved research protocols. Institutional Review Board approval has been obtained, and informed consent procedures are implemented as required by the approved protocol and applicable regulations.
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patient allocation to MRI (n=60) and FDG-PET/CT (n=60) groups with stratification by spinal re-gion | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Short-term physiological effects of contrast-enhanced MRI and FDG-PET/CT, assessed via changes in renal function and hematologic parameters:
Serum blood urea nitrogen (BUN) at baseline and 48 hours post-imaging Estimated glomerular filtration rate (eGFR) at baseline and 48 hours post-imaging Hemoglobin levels at baseline and 48 hours post-imaging Qualitative image evaluation, measured by Visual Grading Analysis (VGA) performed by blinded radiologists to assess anatomical clarity, lesion delineation, and overall diagnostic usability.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start5 Apr 2025
- Primary completion3 Nov 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Short-Term Renal-Hematologic SafetyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Elgendi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640386
- Sponsor's protocol ID
- DDMFDW6dc1
- Status last verified
- Jun 2026
- First submitted
- 31 May 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Contrast-Enhanced MRI and FDG-PET/CT in Spinal Pathology: Image Quality and Short-Term Renal-Hematologic Safety
- ClinicalTrials.gov ID
- NCT07640386
- Acronym / sponsor ID
- DDMFDW6dc1
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Apr 2025 (actual)
- Primary completion
- 3 Nov 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study Population
Eligible participants are adults with clinically suspected or confirmed cervical or lumbar spinal pathology requiring advanced imaging evaluation. Conditions may include degenerative, inflammatory, infectious, neoplastic, traumatic, or post-surgical spinal disorders.
Imaging Procedures
MRI examinations are performed using a 3 Tesla scanner equipped with a dedicated spinal coil. Standard spinal imaging protocols include sagittal and axial T1-weighted and T2-weighted sequences. Intravenous gadolinium-based contrast administration is performed according to institutional guidelines and standard clinical practice.
FDG-PET/CT examinations are performed following standard patient preparation procedures, including fasting requirements and blood glucose assessment. Intravenous administration of 18F-fluorodeoxyglucose (FDG) is followed by image acquisition using routine clinical PET/CT protocols. CT acquisition is used for attenuation correction and anatomical localization according to institutional practice.
Image Quality Assessment
Quantitative image quality assessment includes measurement of signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) using standardized regions of interest. Measurements are performed using predefined image analysis procedures to ensure consistency across participants.
Qualitative image quality assessment is performed using Visual Grading Analysis (VGA). Independent blinded radiologists evaluate image quality using predefined criteria related to anatomical detail, tissue contrast, lesion conspicuity, image noise, and overall diagnostic usability.
Physiological and Safety Assessments
Short-term physiological effects associated with imaging procedures are evaluated using laboratory measurements obtained before imaging and 48 hours after imaging. Laboratory assessments include blood urea nitrogen (BUN), estimated glomerular filtration rate (eGFR), and hemoglobin concentration.
Routine safety monitoring is performed according to institutional standards. Adverse events associated with contrast administration or imaging procedures are documented and managed according to standard clinical protocols.
Subgroup Analyses
Prespecified subgroup analyses evaluate image quality metrics according to spinal region (cervical versus lumbar) and age group (50 years or younger versus older than 50 years). These analyses are intended to explore potential differences in imaging performance across clinically relevant patient subgroups.
Study Objectives
The primary objectives are to compare quantitative image quality metrics between contrast-enhanced MRI and FDG-PET/CT and to evaluate qualitative image quality using blinded radiologist assessment.
Secondary objectives include assessment of short-term changes in renal and hematologic laboratory parameters following imaging procedures performed as part of routine clinical care.
Ethics
The study is conducted in accordance with applicable ethical principles, institutional policies, and approved research protocols. Institutional Review Board approval has been obtained, and informed consent procedures are implemented as required by the approved protocol and applicable regulations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient allocation to MRI (n=60) and FDG-PET/CT (n=60) groups with stratification by spinal re-gion | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quantitative Image Quality Assessment
Time frame: Assessed at the imaging visit (up to 1 day).
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
1 secondary outcome
Comparative Evaluation of Image Quality and Short-Term Physiological Effects of Contrast-Enhanced MRI versus FDG-PET/CT in Cervical and Lumbar Spine Pathologies
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Results publicationReferences 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
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Short-Term Renal-Hematologic Safety and Contrast-Enhanced MRI and FDG-PET/CT, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative Image Quality Assessment (time frame: Assessed at the imaging visit (up to 1 day).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07640386, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.