Prospective pilot study to evaluate the value of functional and structural tissue parameters of transplant kidneys with and without graft functional deterioration in magnetic resonance imaging.

Prospective pilot study to evaluate the value of functional and structural tissue parameters of transplant kidneys with and without graft functional deterioration in magnetic resonance imaging. - NTX_fMRT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00029979

Enrollment

Registered

2022-08-10

Start date

2022-08-24

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Z94.0

Interventions

Group 1: For patients in cohort 1: The first study-related fMRI scan will be performed prior to planned renal biopsy (same day if possible) after laboratory diagnosis of graft function decline with cl

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Cohort 1: - Graft function deterioration requiring renal biopsy, - Age >18 years, - Written informed consent from the patient. Cohort 2: - Stable renal graft function for at least 6 months, - eGFR >30 ml/min/1.73m², - No known renal artery stenosis, - Age >18 years, - Written informed consent from the patient.

Exclusion criteria

Exclusion criteria: - Presence of non-MR implants or any type of metal in and on the body, - Individuals who report hearing disease or increased sensitivity to loud sounds, - Individuals with impaired temperature sensation and/or increased sensitivity to heating of the body, - Persons suffering from claustrophobia, - Pregnant/breastfeeding women, - Limited capacity of the patient to give consent, - Patients with >150 kg body weight, - Patients who do not want to be informed about incidental findings.

Design outcomes

Primary

Measure	Time frame
Detection of morphological and functional differences between graft kidneys with graft function deterioration and stable graft function using multiparametric fMRI and subsequent correlation with clinical reference standards (laboratory parameters, sonography, renal biopsy).	—

Secondary

Measure	Time frame
- Development and evaluation of software algorithms for automated image registration, organ segmentation and multiparametric evaluation of transplant kidneys. - Determination of possible MR biomarkers for monitoring organ function of transplant kidneys.	—

Countries

Germany

Contacts

Public ContactMartina Guthoff

Universitätsklinikum Tübingen, Innere Medizin IV, Abteilung für Diabetologie, Endokrinologie, Nephrologie, Sektion Nieren- & Hochdruckkrankheiten

martina.guthoff@med.uni-tuebingen.de07071-2982857

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026