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Observation Study for Prediction of Allograft Survival and Impact of Imaging in Kidney Transplant Recipients.

NCT03764124 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2024-05-09

No results posted yet for this study

Summary

To further develop personalized medicine in kidney transplantation and improve transplant patient outcomes, attention has been given to define early surrogate endpoints that might aid therapeutic interventions, and help clinical decision-making.

To adequately predict transplant patients' individual risks of allograft loss and patients' complications, this would require a complex integration of data, including: donor data, recipient characteristics, transplant characteristics, biopsies results, immunosuppressive regimen, allograft infections, acute kidney injuries, recipient immune profiles, protocol and per cause biopsies and imaging (PET/CT imaging).

This project aims:

1. Assessed the usefulness of 18F-FDG PET/CT imaging in kidney transplantation recipients presenting with suspected acute rejection who underwent a transplant needle biopsy;
2. To develop a prognostic risk score to predict kidney allograft survival;
3. To evaluate the impact of corticoids withdrawal on long term outcomes (risk of rejection and impact on bone mineral density);
4. Evaluate the type and the frequencies of complications in our kidney transplant population

Conditions

  • Kidney Transplantation

Interventions

DIAGNOSTIC_TEST

PET/CT imaging

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 were applied.

Sponsors & Collaborators

  • University of Liege

    lead OTHER

Principal Investigators

  • FRANCOIS JOURET, PhD · CHU Liege department of Nephrology-Dialysis and Transplantation, and Groupe Interdisciplinaire de Géno-protéomique Appliquée, Cardiovascular Sciences.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-01
Primary Completion
2024-08-31
Completion
2024-08-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03764124 on ClinicalTrials.gov