Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04702022

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Kidney transplant recipients aged over 18 years
  • All sexes eligible
Not 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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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

Long-term Monitoring

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

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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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