Actively Recruiting
Non-invasive Diagnosis and Management of Subclinical Rejection in Kidney Transplant Patients Using 18F-fluorodeoxy Glucose Positron Emission Tomography (18FDG-PET/CT)
Led by University of Liege · Updated on 2025-04-09
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating non-invasive methods to diagnose and manage subclinical acute rejection in kidney transplant patients. The study focuses on comparing the use of 18-fluoro-deoxy-glucose positron emission tomography combined with computed tomography (18FDG PET/CT) with the standard renal biopsy performed approximately three months after transplantation. This approach aims to reduce the need for invasive biopsies and support decisions on corticosteroid withdrawal by detecting metabolic activity indicative of rejection. Participants undergo 18FDG PET/CT imaging on the day of their scheduled surveillance biopsy. Based on biopsy and PET/CT results, patients are categorized into three groups: those with humoral rejection receive standard treatment and exit the study; those without humoral rejection but with high metabolic activity on PET/CT also continue standard care; and those without humoral rejection and low metabolic activity have their corticosteroid treatment gradually reduced. Throughout the study, kidney transplant patients receive regular assessments including histological analysis of biopsy samples by blinded pathologists and PET/CT imaging with standardized procedures. Researchers measure metabolic activity ratios and track outcomes such as prediction of rejection at three months and corticosteroid withdrawal at six months. Follow-up includes monitoring graft rejection at six months and one year, providing comprehensive data on the safety and utility of PET/CT in managing subclinical rejection.
CONDITIONS
Brief Title
Added Value of 18 FDG Pet-scanner in Diagnosis and Management of Subclinical Rejection in Kidney Transplant Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Kidney transplant recipients aged over 18 years
- All sexes eligible
You will not qualify if you...
- Pregnant patients
- Patients with polyomavirus nephropathy
- Highly sensitised patients with historical or 3-month donor specific antibodies
- Patients not allowed corticosteroid withdrawal (e.g., second kidney transplantation or primary disease)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within a 48-hour period around the biopsy at ~3 months post-transplant
Participants undergo a PET/CT scan and a surveillance transplant biopsy at approximately 3 months post kidney transplantation to assess metabolic activity and detect subclinical rejection.
1 visit for PET/CT and biopsy procedures
Duration - Up to 9 months after diagnostic evaluation (up to 1 year post-transplant)
Participants are monitored for kidney transplant health and rejection outcomes up to 1 year post-transplant, including corticosteroid withdrawal for those with low metabolic activity detected by PET/CT.
Follow-up visits during the 6 to 12 month period as per clinical care
Trial Site Locations
Total: 1 location
1
Antoine Bouquegneau
Liège, Liège, Belgium, 4000
Actively Recruiting
Research Team
A
Antoine Bouquegneau
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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