Added Value of 18 FDG Pet-scanner in Diagnosis and Management of Subclinical Rejection in Kidney Transplant Patients

NCT04702022 | Recruiting

• 1 other identifier: Liege AVOID
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The renal biopsy (RB) represents the gold-standard for the diagnosis of acute renal transplant rejection (AR), and allows early verification of a so-called "subclinical" rejection, ie without any clinical or biological abnormality detectable in a stable kidney transplant patient. The RB also makes it possible to certify a strictly normal renal histology and thus to motivate the withdrawal of corticosteroid therapy. It is this 3-month post-transplant protocol RB protocol that has been effective since 2007 at the CHU Liège. However, RB is an invasive procedure, contraindicated in patients taking anticoagulants, and carrying a significant risk of complications. The potential complications associated with RB motivate the identification and validation of other diagnostic means. In the present project, the investigators propose to study the relevance of positron emission tomography (PET), coupled with conventional tomography (CT), after intravenous injection of 18-fluoro-deoxy-glucose (18FDG) in the overall protocol of the renal transplant patient at 3 months post-transplant to: (i) allow protocol renal biopsy only in patients with suspicion of an acute rejection (ii) be a decision maker for withdrawal from corticosteroids in the absence of rejection In practice, the investigators suggest performing 18FDG PET / CT imaging on the day of the surveillance biopsy, which is systematically performed in all kidney transplant patients at University Hospital of Liège 3 months after transplant. The investigators are considering 3 scenarios:

• Scenario 1. The renal biopsy shows signs of humoral rejection: the patient is excluded from the study and is treated "as usual" on the basis of the histological results.
• Scenario 2. The renal biopsy does not show signs of humoral rejection but the 18FDG PET / CT shows a high metabolic activity of the graft (\> 2.4): the patient is treated "as usual" on the basis of histological findings.
• Scenario 3. The renal biopsy does not show signs of humoral rejection and the 18FDG PET / CT shows a weak metabolic activity of the graft (\<2.4): the immunosuppressive treatment is gradually weaned off corticosteroids. This clinical research project is interested in a major health problem in the follow-up of renal transplant patients, and could make it possible to improve the management of a subclinical rejection of the renal transplant and to increase the withdrawal of corticosteroids including side effects are well known.

Conditions

Kidney Transplant Rejection; Kidney Transplant; Complications

Keywords

PET/CT imaging; Corticoids withdrawal; SubClinical Rejection

Outcome Measures

Primary Outcomes (2)

• Prediction of rejection with 18 FDG data

  use the measurement of renal accumulation of the 18FDG marker at the level of the renal graft as a non-invasive indicator of the absence of a subclinical cellular rejection and to use the information from the renal biopsy only if the metabolic activity of the graft is increased.

  at 3 months

• Withdrawal of corticosteroids with 18FDG data

  use the measurement of renal accumulation of the 18FDG marker in the renal graft as a non-invasive indicator of the absence of cell rejection and to initiate the withdrawal of corticosteroids if the metabolic activity of the graft is normal

  At 6 months

Secondary Outcomes (1)

• Allograft rejection

  at 6 months and 1year

Study Arms (3)

Humoral Arm

OTHER

The renal biopsy shows signs of humoral rejection: the patient is excluded from the study and is treated "as usual" on the basis of the histological results.

Diagnostic Test: 18FDG PET / CT

"Highly Metabolic patients"

OTHER

The renal biopsy does not show signs of humoral rejection but the 18FDG PET / CT shows a high metabolic activity of the graft (\> 2.4): the patient is treated "as usual" on the basis of histological findings.

Diagnostic Test: 18FDG PET / CT

" Low metabolic patients"

OTHER

The renal biopsy does not show signs of humoral rejection and the 18FDG PET / CT shows a weak metabolic activity of the graft (\<2.4): the immunosuppressive treatment is gradually weaned off corticosteroids.

Diagnostic Test: 18FDG PET / CT

Interventions

18FDG PET / CT DIAGNOSTIC_TEST

The PET/CT procedure was performed using cross-calibrated Philips Gemini TF Big Bore or TF 16 PET/CT systems (Philips Medical Systems, Cleveland, OH) at 201 18 minutes following intravenous injection of a mean dose of 3.2 0.2 MBq/kg of body weight of 18 F-FDG. A low-dose helical CT (5-mm slice thickness, 120-kV tube voltage, and 40-mAs tube current-time product) centered to the renal transplant was performed, followed by PET scanning with two bed positions, each lasting 240 seconds. Images were reconstructed using iterative list mode time-of-flight algorithms. Corrections for attenuation, dead time and random and scatter events will be applied.

" Low metabolic patients"; "Highly Metabolic patients"; Humoral Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Kidney recipients aged over 18 and of all sexes

You may not qualify if:

• Pregnant patients
• Polyomavirus nephropathy
• Highly sensitised patients (historical or at 3 months Donor specific antibodies)
• No corticosteroids withdrawal allowed (second kidney transplantation or primary disease)

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

Antoine Bouquegneau

Liège, Liège, 4000, Belgium

RECRUITING

Study Officials

• Francois Jouret

  University of Liege

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antoine Bouquegneau

CONTACT

+32473353321; antoine.bouquegneau@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 8, 2021
• Study Start: January 4, 2021
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 9, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)