- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06268067
Kidney Uptake at F-18 FDG PET/CT Studies and Renal Function Status
The Association of Kidney Uptake at F-18 FDG PET/CT Studies and Renal Function Status
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
F-18-Fluoro-Deoxy-Glucose Positron Emission Tomography (F-18 FDG PET/CT) is a hybrid imaging modality that in the last few years has been gaining more attention, due to its ability for evaluation different conditions, both neoplastic or benign. In the urinary tract, FDG is filtered by the glomerulus and is not reabsorbed by the renal tubules. So, significant activity may be displayed in any part of the urinary tract. Chronic kidney disease is highly prevalent and associated with higher cardiovascular risk. CKD is diagnosed when an estimated glomerular filtration rate (EGFR) lower than 60 mL/min/1.73 m2 present for at least three months or by alteration in the renal structure[3]. The Kidney Disease: Improving Global Outcomes (KDIGO) CKD guidelines recommend use of the EGFR for determination of the disease because of its simplicity, cost-effectiveness, and accuracy in predicting renal function in standard conditions. The estimating equation for the assessment of EGFR in adults is the CKD Epidemiology Collaboration (CKD-EPI).
In some cases, it has been reported that the impairment of renal function doesn't significantly compromise the clearance of background activity of F-18-FDG. In contrast, other papers observed that CKD patients have a higher physiological tracer uptake in the liver and blood pool. Different studies investigated the ability of CKD in modification of the F-18-FDG uptake during a PET/CT scan have also been published with contradictory results.
Therefore, we search for the association between renal uptake at F-18-FDG PET/CT and renal functional parameters in both normal subjects and CKD patients.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Rana M Farghali, Master
- Phone Number: 01014491926
- Email: drrana.m.f@aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Adult patients undergoing PET/CT examination for oncologic or non-oncologic purposes.
For all the patients included in this study, data about serum Cr levels and estimated glomerular filtration rate (EGFR) calculated with the CKD-EPI formula.
Description
Inclusion Criteria:
- Adult patients undergoing PET/CT examination for oncologic or non-oncologic purposes.
Exclusion Criteria:
- Patients underwent PET/CT examination with age under 18 years.
- Presence of pathological conditions affecting kidneys (e.g., cancers, inflammation, polycystic kidney disease)
- Inability to stay still for the duration of the scan.
- Claustrophobia.
- Patients with uncontrolled diabetics (blood glucose >200 mg/dl immediately before PET/CT scan)
- Pregnant females.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Normal
normal subjects
|
F-18 FDG PET/CT studies
|
Chronic kidney diseased patiens
chronic kidney diseased patients
|
F-18 FDG PET/CT studies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
significance of renal uptake at F18-FDG PET CT studies
Time Frame: one year
|
The study assesses the significance of renal uptake at F18-FDG PET CT studies as regards Cr levels and EGFR.
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Early detection of patients with CKD
Time Frame: one year
|
• Early detection of patients with CKD to initiate appropriate treatment for them, with subsequently improving the survival and quality of life.
|
one year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Dondi F, Pisani AR, Lucarelli NM, Gazzilli M, Talin A, Albano D, Rubini D, Maggialetti N, Rubini G, Bertagna F. Correlation between Kidney Uptake at [18F]FDG PET/CT and Renal Function. J Pers Med. 2023 Dec 28;14(1):40. doi: 10.3390/jpm14010040.
- Ammirati AL. Chronic Kidney Disease. Rev Assoc Med Bras (1992). 2020 Jan 13;66Suppl 1(Suppl 1):s03-s09. doi: 10.1590/1806-9282.66.S1.3.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Renal uptake at F18 FDG PET/CT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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