Renal Uptake at F-18-FDG PET/CTNCT06268067
Kidney Uptake at F-18 FDG PET/CT Studies and Renal Function Status
An observational study of Renal Uptake at F-18-FDG PET/CT, run by Assiut University.
Trial summary
Searching for a possible correlation between renal uptake at F-18-FDG PET/CT and renal functional parameters in both normal subjects and patients with CKD. Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Uptake at F-18-FDG PET/CT
- What is being tested?
- PET/CT
- Type of treatment
- Medical device
- How many people
- 97 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 Apr 2025
- 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 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Adult patients undergoing PET/CT examination for oncologic or non-oncologic purposes.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Association of Kidney Uptake at F-18 FDG PET/CT Studies and Renal Function Status
Searching for a possible correlation between renal uptake at F-18-FDG PET/CT and renal functional parameters in both normal subjects and patients with CKD.
Read the 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.
- Conditions
- Renal Uptake at F-18-FDG PET/CT
- Being tested
- PET/CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CTDevice
F-18 FDG PET/CT studies
| Study group | Role | What they receive |
|---|---|---|
| Chronic kidney diseased patiens | chronic kidney diseased patients Receives: Device: PET/CT | |
| Normal | normal subjects Receives: Device: PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
significance of renal uptake at F18-FDG PET CT studies
The study assesses the significance of renal uptake at F18-FDG PET CT studies as regards Cr levels and EGFR.
Measured: one year
Secondary outcomes (1)
Early detection of patients with CKD
- Early detection of patients with CKD to initiate appropriate treatment for them, with subsequently improving the survival and quality of life.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Renal Uptake at F-18-FDG PET/CTStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 97 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Mahmoud Farghali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268067
- Sponsor's protocol ID
- Renal uptake at F18 FDG PET/CT
- Status last verified
- Feb 2024
- First submitted
- 13 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 38248741Ammirati 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.
PubMed 31939529
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Kidney Uptake at F-18 FDG PET/CT Studies and Renal Function Status
- ClinicalTrials.gov ID
- NCT06268067
- Acronym / sponsor ID
- Renal uptake at F18 FDG PET/CT
- Conditions
- Renal Uptake at F-18-FDG PET/CT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 20 Feb 2024 (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.
Searching for a possible correlation between renal uptake at F-18-FDG PET/CT and renal functional parameters in both normal subjects and patients with CKD.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic kidney diseased patiens | – | Device: PET/CTchronic kidney diseased patients |
| Normal | – | Device: PET/CTnormal subjects |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Adult patients undergoing PET/CT examination for oncologic or non-oncologic purposes.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/CTF-18 FDG PET/CT studies | Device | Chronic kidney diseased patiens, Normal |
Primary outcome
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.
1 secondary outcome
Early detection of patients with CKD
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Results publication: PubMed 38248741Dondi 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.
- Results publication: PubMed 31939529Ammirati 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.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Uptake at F-18-FDG PET/CT, run by Assiut University.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rana M Farghali, Master (01014491926, drrana.m.f@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
significance of renal uptake at F18-FDG PET CT studies (time frame: one year). 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 NCT06268067, which also lists 2 linked publications.
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 20 Feb 2024.